The MSAT Engineer - Analytics will support the development and execution of process analytics, process support, and control strategy activities with limited supervision and guidance. This role will be ~50% process analytics and 50% process engineering support. This role will collaborate effectively with personnel in Manufacturing, Engineering, Process Development, Quality Assurance, and Quality Control utilizing strong communication, and technical expertise to maintain and improve manufacturing operations.
Remote Work Designation : Not Remote
Major Accountabilities:
Provides advanced level support for execution and development of the manufacturing control strategy and Process Analytics program
Acquires, analyses, and reports data trends using graphical and statistical methods and utilizes expertise to make recommendations to next level management based on data analysis
Develops systems and processes for the acquisition and analysis of data trends from process, equipment, and raw materials.
Applies statistical process control techniques to independently develop and implement (following appropriate change control) process specifications, parameters, operating ranges, and action limits.
Supports the execution of commercial manufacturing campaigns
Provides guidance to others on advanced and/or moderately complex theory and concepts behind the process including an understanding of the impact of any process changes or improvements, as well as the impact of any process deviations or drift
Proactively identifies technical issues on bioprocessing equipment and recommends activities to resolve the issue. Implements procedures and activities to prevent the same issue from occurring.
Authors standard operating procedures, reports, and protocols and solicit next level manager approval for final documents
Special Competencies:
Advanced knowledge of statistical process control methods and data interpretation
Knowledge of multivariate modeling techniques
Familiarity with data engineering concept for collection, storage, and validation of data
Demonstrated technical foundation of cell- and tissue- based products and a strong familiarity with GMP manufacturing
Able to independently troubleshoot advanced or moderately complex bioprocess activities and perform typical and atypical bioprocess optimization studies
Possesses advanced knowledge of the cell biological aspects of the process, as well as the engineering and mass-transfer aspects of the process
Possesses understanding and demonstrated knowledge of equipment and procedures and identifies potential problem before they occur
General Competencies:
Able to communicate effectively in English, both verbally and in writing
Possess a positive roll-up-the-sleeves attitude and optimistic outlook
Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
Excellent organizational and time management skills with ability to set own priorities in a timely manner
High degree of flexibility and adaptability
Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
Must be able to work as needed to meet tight deadlines and at peak periods
Self-motivated and organized critical thinker with solid interpersonal and business communication skills
Demonstrated ability to work in a cross functional team
Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
Always observe safety precautions and regulations in all areas where duties are performed
Responsible for reporting all safety hazards and potential unsafe working conditions
Ensures Humacyte or other required trainings/certifications are up to date
Represents the organization in a positive and professional manner
Reports to work on time and as scheduled
Qualifications:
BS in Engineering or other relevant discipline required.
MS in related discipline preferred.
Background in chemical engineering, biochemical engineering, biotechnology, bioprocess, cell therapy, tissue engineering, regenerative medicine, or process development required.
Minimum of 2 years of commercial manufacturing or Phase 3 CDMO or 6 years Phase 1-3 clinical manufacturing experience required.
Demonstrated experience with the Process Validation Lifecycle and Statistical Process Control methods
Experience with application of analytical systems and computational methods to biological systems in a GMP environment
Demonstrated experience leading basic troubleshooting and participating in complex troubleshooting/
Possess a demonstrated technical foundation of cell- and tissue- based products.
Experience with bioprocessing deviations, change control, process optimization, and technical troubleshooting.
Works well in a team environment.
Strong experience working cross functionally within a BioPharma Bioprocessing organization.
Apr 24, 2024
Full time
The MSAT Engineer - Analytics will support the development and execution of process analytics, process support, and control strategy activities with limited supervision and guidance. This role will be ~50% process analytics and 50% process engineering support. This role will collaborate effectively with personnel in Manufacturing, Engineering, Process Development, Quality Assurance, and Quality Control utilizing strong communication, and technical expertise to maintain and improve manufacturing operations.
Remote Work Designation : Not Remote
Major Accountabilities:
Provides advanced level support for execution and development of the manufacturing control strategy and Process Analytics program
Acquires, analyses, and reports data trends using graphical and statistical methods and utilizes expertise to make recommendations to next level management based on data analysis
Develops systems and processes for the acquisition and analysis of data trends from process, equipment, and raw materials.
Applies statistical process control techniques to independently develop and implement (following appropriate change control) process specifications, parameters, operating ranges, and action limits.
Supports the execution of commercial manufacturing campaigns
Provides guidance to others on advanced and/or moderately complex theory and concepts behind the process including an understanding of the impact of any process changes or improvements, as well as the impact of any process deviations or drift
Proactively identifies technical issues on bioprocessing equipment and recommends activities to resolve the issue. Implements procedures and activities to prevent the same issue from occurring.
Authors standard operating procedures, reports, and protocols and solicit next level manager approval for final documents
Special Competencies:
Advanced knowledge of statistical process control methods and data interpretation
Knowledge of multivariate modeling techniques
Familiarity with data engineering concept for collection, storage, and validation of data
Demonstrated technical foundation of cell- and tissue- based products and a strong familiarity with GMP manufacturing
Able to independently troubleshoot advanced or moderately complex bioprocess activities and perform typical and atypical bioprocess optimization studies
Possesses advanced knowledge of the cell biological aspects of the process, as well as the engineering and mass-transfer aspects of the process
Possesses understanding and demonstrated knowledge of equipment and procedures and identifies potential problem before they occur
General Competencies:
Able to communicate effectively in English, both verbally and in writing
Possess a positive roll-up-the-sleeves attitude and optimistic outlook
Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
Excellent organizational and time management skills with ability to set own priorities in a timely manner
High degree of flexibility and adaptability
Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
Must be able to work as needed to meet tight deadlines and at peak periods
Self-motivated and organized critical thinker with solid interpersonal and business communication skills
Demonstrated ability to work in a cross functional team
Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
Always observe safety precautions and regulations in all areas where duties are performed
Responsible for reporting all safety hazards and potential unsafe working conditions
Ensures Humacyte or other required trainings/certifications are up to date
Represents the organization in a positive and professional manner
Reports to work on time and as scheduled
Qualifications:
BS in Engineering or other relevant discipline required.
MS in related discipline preferred.
Background in chemical engineering, biochemical engineering, biotechnology, bioprocess, cell therapy, tissue engineering, regenerative medicine, or process development required.
Minimum of 2 years of commercial manufacturing or Phase 3 CDMO or 6 years Phase 1-3 clinical manufacturing experience required.
Demonstrated experience with the Process Validation Lifecycle and Statistical Process Control methods
Experience with application of analytical systems and computational methods to biological systems in a GMP environment
Demonstrated experience leading basic troubleshooting and participating in complex troubleshooting/
Possess a demonstrated technical foundation of cell- and tissue- based products.
Experience with bioprocessing deviations, change control, process optimization, and technical troubleshooting.
Works well in a team environment.
Strong experience working cross functionally within a BioPharma Bioprocessing organization.
M3 Engineering & Technology
Charlotte, NC 28226, USA
Knowledge of Revit, AutoCAD, RISA 3D & MS Office. Produce design drawings. The position requires specification writing/editing abilities. Preparation of equipment bid packages, shop drawings, review and report writing.
Interaction and coordinate with clients, vendors, co-workers, other disciplines, and departments as necessary to coordinate and effectively communicate project design goals, needs and overall status.
Provide filed assistance and front-end information gathering at project sites when needed.
Must be able to work in a project team and maintain a project schedule, be a self-starter, detailed oriented and have exceptional organizational skills.
Must be able to interact with clients and co-workers in a professional and respectful manner and work in a team environment sharing roles and responsibilities with limited supervision.
Industrial and construction field is a plus!
Apr 18, 2024
Full time
Knowledge of Revit, AutoCAD, RISA 3D & MS Office. Produce design drawings. The position requires specification writing/editing abilities. Preparation of equipment bid packages, shop drawings, review and report writing.
Interaction and coordinate with clients, vendors, co-workers, other disciplines, and departments as necessary to coordinate and effectively communicate project design goals, needs and overall status.
Provide filed assistance and front-end information gathering at project sites when needed.
Must be able to work in a project team and maintain a project schedule, be a self-starter, detailed oriented and have exceptional organizational skills.
Must be able to interact with clients and co-workers in a professional and respectful manner and work in a team environment sharing roles and responsibilities with limited supervision.
Industrial and construction field is a plus!
M3 Engineering & Technology
Charlotte, NC 28226, USA
Knowledge of Revit, AutoCAD, RISA 3D & MS Office. Produce design drawings. The position requires specification writing/editing abilities. Preparation of equipment bid packages, shop drawings, review and report writing.
Interaction and coordinate with clients, vendors, co-workers, other disciplines, and departments as necessary to coordinate and effectively communicate project design goals, needs and overall status.
Provide filed assistance and front-end information gathering at project sites when needed.
Must be able to work in a project team and maintain a project schedule, be a self-starter, detailed oriented and have exceptional organizational skills.
Must be able to interact with clients and co-workers in a professional and respectful manner and work in a team environment sharing roles and responsibilities with limited supervision.
Industrial and construction field is a plus!
Apr 18, 2024
Full time
Knowledge of Revit, AutoCAD, RISA 3D & MS Office. Produce design drawings. The position requires specification writing/editing abilities. Preparation of equipment bid packages, shop drawings, review and report writing.
Interaction and coordinate with clients, vendors, co-workers, other disciplines, and departments as necessary to coordinate and effectively communicate project design goals, needs and overall status.
Provide filed assistance and front-end information gathering at project sites when needed.
Must be able to work in a project team and maintain a project schedule, be a self-starter, detailed oriented and have exceptional organizational skills.
Must be able to interact with clients and co-workers in a professional and respectful manner and work in a team environment sharing roles and responsibilities with limited supervision.
Industrial and construction field is a plus!
M3 Engineering & Technology
Charlotte, NC 28226, USA
Knowledge of Revit, AutoCAD, RISA 3D & MS Office. Produce design drawings. The position requires specification writing/editing abilities. Preparation of equipment bid packages, shop drawings, review and report writing.
Interaction and coordinate with clients, vendors, co-workers, other disciplines, and departments as necessary to coordinate and effectively communicate project design goals, needs and overall status.
Provide filed assistance and front-end information gathering at project sites when needed.
Must be able to work in a project team and maintain a project schedule, be a self-starter, detailed oriented and have exceptional organizational skills.
Must be able to interact with clients and co-workers in a professional and respectful manner and work in a team environment sharing roles and responsibilities with limited supervision.
Industrial and construction field is a plus!
Apr 18, 2024
Full time
Knowledge of Revit, AutoCAD, RISA 3D & MS Office. Produce design drawings. The position requires specification writing/editing abilities. Preparation of equipment bid packages, shop drawings, review and report writing.
Interaction and coordinate with clients, vendors, co-workers, other disciplines, and departments as necessary to coordinate and effectively communicate project design goals, needs and overall status.
Provide filed assistance and front-end information gathering at project sites when needed.
Must be able to work in a project team and maintain a project schedule, be a self-starter, detailed oriented and have exceptional organizational skills.
Must be able to interact with clients and co-workers in a professional and respectful manner and work in a team environment sharing roles and responsibilities with limited supervision.
Industrial and construction field is a plus!
M3 Engineering & Technology
Charlotte, NC 28226, USA
Knowledge of Revit, AutoCAD, RISA 3D & MS Office. Produce design drawings. The position requires specification writing/editing abilities. Preparation of equipment bid packages, shop drawings, review and report writing.
Interaction and coordinate with clients, vendors, co-workers, other disciplines, and departments as necessary to coordinate and effectively communicate project design goals, needs and overall status.
Provide filed assistance and front-end information gathering at project sites when needed.
Must be able to work in a project team and maintain a project schedule, be a self-starter, detailed oriented and have exceptional organizational skills.
Must be able to interact with clients and co-workers in a professional and respectful manner and work in a team environment sharing roles and responsibilities with limited supervision.
Industrial and construction field is a plus!
Apr 18, 2024
Full time
Knowledge of Revit, AutoCAD, RISA 3D & MS Office. Produce design drawings. The position requires specification writing/editing abilities. Preparation of equipment bid packages, shop drawings, review and report writing.
Interaction and coordinate with clients, vendors, co-workers, other disciplines, and departments as necessary to coordinate and effectively communicate project design goals, needs and overall status.
Provide filed assistance and front-end information gathering at project sites when needed.
Must be able to work in a project team and maintain a project schedule, be a self-starter, detailed oriented and have exceptional organizational skills.
Must be able to interact with clients and co-workers in a professional and respectful manner and work in a team environment sharing roles and responsibilities with limited supervision.
Industrial and construction field is a plus!
M3 Engineering & Technology
Charlotte, NC 28226, USA
Knowledge of Revit, AutoCAD, RISA 3D & MS Office. Produce design drawings. The position requires specification writing/editing abilities. Preparation of equipment bid packages, shop drawings, review and report writing.
Interaction and coordinate with clients, vendors, co-workers, other disciplines, and departments as necessary to coordinate and effectively communicate project design goals, needs and overall status.
Provide filed assistance and front-end information gathering at project sites when needed.
Must be able to work in a project team and maintain a project schedule, be a self-starter, detailed oriented and have exceptional organizational skills.
Must be able to interact with clients and co-workers in a professional and respectful manner and work in a team environment sharing roles and responsibilities with limited supervision.
Industrial and construction field is a plus!
Apr 18, 2024
Full time
Knowledge of Revit, AutoCAD, RISA 3D & MS Office. Produce design drawings. The position requires specification writing/editing abilities. Preparation of equipment bid packages, shop drawings, review and report writing.
Interaction and coordinate with clients, vendors, co-workers, other disciplines, and departments as necessary to coordinate and effectively communicate project design goals, needs and overall status.
Provide filed assistance and front-end information gathering at project sites when needed.
Must be able to work in a project team and maintain a project schedule, be a self-starter, detailed oriented and have exceptional organizational skills.
Must be able to interact with clients and co-workers in a professional and respectful manner and work in a team environment sharing roles and responsibilities with limited supervision.
Industrial and construction field is a plus!
M3 Engineering & Technology
Charlotte, NC 28226, USA
Knowledge of Revit, AutoCAD, RISA 3D & MS Office. Produce design drawings. The position requires specification writing/editing abilities. Preparation of equipment bid packages, shop drawings, review and report writing.
Interaction and coordinate with clients, vendors, co-workers, other disciplines, and departments as necessary to coordinate and effectively communicate project design goals, needs and overall status.
Provide filed assistance and front-end information gathering at project sites when needed.
Must be able to work in a project team and maintain a project schedule, be a self-starter, detailed oriented and have exceptional organizational skills.
Must be able to interact with clients and co-workers in a professional and respectful manner and work in a team environment sharing roles and responsibilities with limited supervision.
Industrial and construction field is a plus!
Apr 18, 2024
Full time
Knowledge of Revit, AutoCAD, RISA 3D & MS Office. Produce design drawings. The position requires specification writing/editing abilities. Preparation of equipment bid packages, shop drawings, review and report writing.
Interaction and coordinate with clients, vendors, co-workers, other disciplines, and departments as necessary to coordinate and effectively communicate project design goals, needs and overall status.
Provide filed assistance and front-end information gathering at project sites when needed.
Must be able to work in a project team and maintain a project schedule, be a self-starter, detailed oriented and have exceptional organizational skills.
Must be able to interact with clients and co-workers in a professional and respectful manner and work in a team environment sharing roles and responsibilities with limited supervision.
Industrial and construction field is a plus!
M3 Engineering & Technology
Charlotte, NC 28226, USA
Knowledge of Revit, AutoCAD, RISA 3D & MS Office. Produce design drawings. The position requires specification writing/editing abilities. Preparation of equipment bid packages, shop drawings, review and report writing.
Interaction and coordinate with clients, vendors, co-workers, other disciplines, and departments as necessary to coordinate and effectively communicate project design goals, needs and overall status.
Provide filed assistance and front-end information gathering at project sites when needed.
Must be able to work in a project team and maintain a project schedule, be a self-starter, detailed oriented and have exceptional organizational skills.
Must be able to interact with clients and co-workers in a professional and respectful manner and work in a team environment sharing roles and responsibilities with limited supervision.
Industrial and construction field is a plus!
Apr 18, 2024
Full time
Knowledge of Revit, AutoCAD, RISA 3D & MS Office. Produce design drawings. The position requires specification writing/editing abilities. Preparation of equipment bid packages, shop drawings, review and report writing.
Interaction and coordinate with clients, vendors, co-workers, other disciplines, and departments as necessary to coordinate and effectively communicate project design goals, needs and overall status.
Provide filed assistance and front-end information gathering at project sites when needed.
Must be able to work in a project team and maintain a project schedule, be a self-starter, detailed oriented and have exceptional organizational skills.
Must be able to interact with clients and co-workers in a professional and respectful manner and work in a team environment sharing roles and responsibilities with limited supervision.
Industrial and construction field is a plus!
Public Utility Commission of Texas
Austin, TX 78711, USA
Perform moderately complex program management work developing, coordinating, implementing, and overseeing the Texas Energy Fund established in Texas Utilities Code Chapter 34, which promotes greater resiliency of the Texas electric grid by establishing loan and grant programs to support the construction, maintenance, and modernization of dispatchable electric generating facilities in Texas. Work involves monitoring and managing the progress, schedule, and quality of the Texas Energy Fund implementation to ensure that program deliverables are acceptable, fulfill the terms of the project contract and legislative specifications, and are completed within budget. Work requires extensive contact with internal and external stakeholders, including Commission attorneys, engineering and regulatory staff, industry representatives, the Texas Treasury Safekeeping Trust Company, and other professional staff. Work under general to limited supervision with moderate to considerable latitude for the use of initiative and independent judgment.
ESSENTIAL FUNCTIONS :
Plan, develop and implement functions of the Texas Energy Fund programs implemented under Public Utility Commission of Texas (PUCT) oversight.
Assist the Project Manager and Contract Administrator for contracts awarded as a part of the Texas Energy Fund project, specifically including oversight of the professional services firm engaged to develop and administer Texas Energy Fund programs.
Develop program information and status reports.
Develop and approve program budgets, schedules, work plans, resource requirements, and cost estimates and projections.
Review any proposed changes to program parameters and changes to original program plan and budget; track the implementation of changes.
Develop and review program plans including timelines and milestones, and contingency planning.
Assist in the development of program goals and objectives consistent with the enabling legislation and the objectives of the Texas Energy Fund programs.
Analyze data and establish criteria for evaluating programs, projects, proposals, and other pertinent information related to program assignments.
Develop and implement plans to communicate program methodology and processes to interested groups and team members.
Establish comprehensive strategies and methodologies for identifying, assessing, reporting, managing, and mitigating risk for the programs.
Monitor and manage program quality and cost to ensure that program deliverables are acceptable, fulfill the terms of the project contract or specifications, and are completed within budget.
Identify and implement process improvements in the area of program management.
Coordinate program activities with other state agencies, governmental entities, or private sector partners and contractors.
Assist with the development and management of the loan and grant application processes.
Review loan and grant applications, reports, and funds release requests.
Identify and implement process improvements throughout program administration.
Identify potential program risks and design strategies to mitigate or avoid and difficulties. Review the financial reporting associated with the Texas Energy Fund programs.
Coordinate program activities with internal and external stakeholders.
Compile and distribute program information, program status reports, and program budget expenditures. May testify before legislative and interested groups on program status and other issues of public interest.
Demonstrate a spirit of teamwork, offering positive and constructive ideas, encouragement, support to other members of the staff and team, and respond professionally to constructive feedback from others, while upholding the PUC’s mission and core values.
Adhere to all PUC personnel policies and division procedures and perform other work as assigned.
REQUIRED MINIMUM QUALIFICATIONS :
Undergraduate degree from an accredited four-year college university; and
Two (2) years of full-time program management experience supporting loans and grant management, and financial activities.
PREFERRED QUALIFICATIONS :
Undergraduate or graduate degree in finance or business.
Experience overseeing grant or loan programs with a state government agency.
Experience with regulatory, statutory, or policy analysis.
Work experience in the Texas electric utility industry.
Apr 01, 2024
Full time
Perform moderately complex program management work developing, coordinating, implementing, and overseeing the Texas Energy Fund established in Texas Utilities Code Chapter 34, which promotes greater resiliency of the Texas electric grid by establishing loan and grant programs to support the construction, maintenance, and modernization of dispatchable electric generating facilities in Texas. Work involves monitoring and managing the progress, schedule, and quality of the Texas Energy Fund implementation to ensure that program deliverables are acceptable, fulfill the terms of the project contract and legislative specifications, and are completed within budget. Work requires extensive contact with internal and external stakeholders, including Commission attorneys, engineering and regulatory staff, industry representatives, the Texas Treasury Safekeeping Trust Company, and other professional staff. Work under general to limited supervision with moderate to considerable latitude for the use of initiative and independent judgment.
ESSENTIAL FUNCTIONS :
Plan, develop and implement functions of the Texas Energy Fund programs implemented under Public Utility Commission of Texas (PUCT) oversight.
Assist the Project Manager and Contract Administrator for contracts awarded as a part of the Texas Energy Fund project, specifically including oversight of the professional services firm engaged to develop and administer Texas Energy Fund programs.
Develop program information and status reports.
Develop and approve program budgets, schedules, work plans, resource requirements, and cost estimates and projections.
Review any proposed changes to program parameters and changes to original program plan and budget; track the implementation of changes.
Develop and review program plans including timelines and milestones, and contingency planning.
Assist in the development of program goals and objectives consistent with the enabling legislation and the objectives of the Texas Energy Fund programs.
Analyze data and establish criteria for evaluating programs, projects, proposals, and other pertinent information related to program assignments.
Develop and implement plans to communicate program methodology and processes to interested groups and team members.
Establish comprehensive strategies and methodologies for identifying, assessing, reporting, managing, and mitigating risk for the programs.
Monitor and manage program quality and cost to ensure that program deliverables are acceptable, fulfill the terms of the project contract or specifications, and are completed within budget.
Identify and implement process improvements in the area of program management.
Coordinate program activities with other state agencies, governmental entities, or private sector partners and contractors.
Assist with the development and management of the loan and grant application processes.
Review loan and grant applications, reports, and funds release requests.
Identify and implement process improvements throughout program administration.
Identify potential program risks and design strategies to mitigate or avoid and difficulties. Review the financial reporting associated with the Texas Energy Fund programs.
Coordinate program activities with internal and external stakeholders.
Compile and distribute program information, program status reports, and program budget expenditures. May testify before legislative and interested groups on program status and other issues of public interest.
Demonstrate a spirit of teamwork, offering positive and constructive ideas, encouragement, support to other members of the staff and team, and respond professionally to constructive feedback from others, while upholding the PUC’s mission and core values.
Adhere to all PUC personnel policies and division procedures and perform other work as assigned.
REQUIRED MINIMUM QUALIFICATIONS :
Undergraduate degree from an accredited four-year college university; and
Two (2) years of full-time program management experience supporting loans and grant management, and financial activities.
PREFERRED QUALIFICATIONS :
Undergraduate or graduate degree in finance or business.
Experience overseeing grant or loan programs with a state government agency.
Experience with regulatory, statutory, or policy analysis.
Work experience in the Texas electric utility industry.