The Senior MSAT/Process Engineer will support the GMP manufacturing of Humacyte’s unique HAV and related products with limited supervision and guidance. This role will collaborate effectively with personnel in Manufacturing, Engineering, Process Development, Quality Assurance, and Quality Control utilizing strong communication, technical expertise and influencing skills to maintain and improve manufacturing operations.
Remote Work Designation : Not Remote
Major Accountabilities:
Serves as a process expert in HAV production systems; able to fully understand the manufacturing process
Primary responsible person to ensure bioprocessing equipment is ready for use when required
Identifies technical issues on bioprocessing equipment and initiates activities to resolve the issue quickly. Identifies and implements procedures and activities to prevent the same issue from occurring.
Lead efforts in troubleshooting out-of-trend manufacturing processes, providing the intellectual, scientific and engineering leadership to identify and implement corrective actions
Provides guidance and is accountable for determining the root causes of equipment related deviations in a timely and conclusive manner.
Ensures deep understanding of standards of practice, process science and departmental policies through participation in training and development opportunities
Provides comprehensive training and guidance to operations staff
Partner with Process Development to ensure successful process transfer
Assist in equipment selection and design, qualification, and start up activities. Work with Bioprocessing to ensure robust procedures are utilized for operation of equipment
Develop and execute test protocols, vendor site visits, FAT/SAT, etc.
Work with the Validation team to develop and execute validation strategies
Identify continuous improvement opportunities in terms of cost savings, process robustness, and manufacturing efficiency gains
Special Competencies:
Possess a demonstrated proficiency working in a Process Engineering role with a clear understanding of GMP manufacturing
Possess a demonstrated technical foundation of cell- and tissue- based products
Strong Scientific and Engineering technical experience performing and supporting cell culture based bioprocessing activities, using adherent mammalian cells preferred
Experience supporting and troubleshooting single use bioprocessing technologies as well as fixed stainless steel bioprocessing equipment
Experience leading projects related to bioprocessing deviations, change control, process optimization, technical troubleshooting, and bioprocessing process changes
Works and leads well in a team environment
Strong experience working cross functionally within a BioPharma Bioprocessing organization
General Competencies:
Able to communicate effectively in English, both verbally and in writing
Possess a positive roll-up-the-sleeves attitude and optimistic outlook
Represents the organization in a positive and professional manner
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
Reports to work on time and as scheduled
Qualifications:
BS degree in relevant discipline, required.
Master’s degree or above in related discipline, preferred.
Background in chemical engineering, biochemical engineering, biotechnology, bioprocess, cell technology, biomedical engineering, cell therapy, tissue engineering, regenerative medicine, or process development required
10 years of relevant pharma or biotech industry experience, minimum 5 years GMP experience required
Apr 24, 2024
Full time
The Senior MSAT/Process Engineer will support the GMP manufacturing of Humacyte’s unique HAV and related products with limited supervision and guidance. This role will collaborate effectively with personnel in Manufacturing, Engineering, Process Development, Quality Assurance, and Quality Control utilizing strong communication, technical expertise and influencing skills to maintain and improve manufacturing operations.
Remote Work Designation : Not Remote
Major Accountabilities:
Serves as a process expert in HAV production systems; able to fully understand the manufacturing process
Primary responsible person to ensure bioprocessing equipment is ready for use when required
Identifies technical issues on bioprocessing equipment and initiates activities to resolve the issue quickly. Identifies and implements procedures and activities to prevent the same issue from occurring.
Lead efforts in troubleshooting out-of-trend manufacturing processes, providing the intellectual, scientific and engineering leadership to identify and implement corrective actions
Provides guidance and is accountable for determining the root causes of equipment related deviations in a timely and conclusive manner.
Ensures deep understanding of standards of practice, process science and departmental policies through participation in training and development opportunities
Provides comprehensive training and guidance to operations staff
Partner with Process Development to ensure successful process transfer
Assist in equipment selection and design, qualification, and start up activities. Work with Bioprocessing to ensure robust procedures are utilized for operation of equipment
Develop and execute test protocols, vendor site visits, FAT/SAT, etc.
Work with the Validation team to develop and execute validation strategies
Identify continuous improvement opportunities in terms of cost savings, process robustness, and manufacturing efficiency gains
Special Competencies:
Possess a demonstrated proficiency working in a Process Engineering role with a clear understanding of GMP manufacturing
Possess a demonstrated technical foundation of cell- and tissue- based products
Strong Scientific and Engineering technical experience performing and supporting cell culture based bioprocessing activities, using adherent mammalian cells preferred
Experience supporting and troubleshooting single use bioprocessing technologies as well as fixed stainless steel bioprocessing equipment
Experience leading projects related to bioprocessing deviations, change control, process optimization, technical troubleshooting, and bioprocessing process changes
Works and leads well in a team environment
Strong experience working cross functionally within a BioPharma Bioprocessing organization
General Competencies:
Able to communicate effectively in English, both verbally and in writing
Possess a positive roll-up-the-sleeves attitude and optimistic outlook
Represents the organization in a positive and professional manner
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
Reports to work on time and as scheduled
Qualifications:
BS degree in relevant discipline, required.
Master’s degree or above in related discipline, preferred.
Background in chemical engineering, biochemical engineering, biotechnology, bioprocess, cell technology, biomedical engineering, cell therapy, tissue engineering, regenerative medicine, or process development required
10 years of relevant pharma or biotech industry experience, minimum 5 years GMP experience required
Position Background:
The Automation Engineer 2 is responsible for supporting any existing and new project automation systems at Humacyte, an FDA regulated site. This includes daily verifications required for data integrity requirements and modifications to the system configuration as required for process, building or historian automation requirements. There is an expectation that the employee will have a primary system responsibility, either DeltaV, PLC, BAS, or PI focused, but will be able to support all automation system as required .
Remote Work Designation : Not Remote
Major Accountabilities:
Utilizing current engineering skills and knowledge, provide routine automation expertise for the development of custom commercial manufacturing equipment for a human acellular vessel product with the guidance and direction of more senior team members and/or manager
Support and maintain existing PI data historian in existing manufacturing and R&D facilities
In collaboration with Senior Automation Engineer and/or Associate Director, Automation, support the installation and validation of a PI data historian for the commercial manufacturing facility
Support the installation and validation of a DeltaV system for the commercial manufacturing process
Support the installation and validation a building automation system for the commercial manufacturing facility
Support the installation and validation of OEM and custom PLCs for the commercial manufacturing process
Assist process development team in testing prototype equipment and by independently developing automation for custom research and development equipment
Promote transparency around process development activities through routine internal updates to direct manager and/or cross-functional colleagues
Support and troubleshooting automation during development, technology transfer, and commercial manufacturing
Perform thorough system tests to ensure robustness of custom automation
Assist in oversight in transition of automated equipment to comply with regulatory and quality control requirements
Assist in the development of automation documentation, including functional requirements, design documents, test protocols, SOPs and reports
Respond to automation-based alarms during standard office hours and as on-call support, as required
Support regulatory filings as required
Other duties, as assigned
Special Competencies:
Demonstrated knowledge and understanding of developing and supporting automation for commercial manufacturing processes
Familiarity with automation of bioprocess applications in GMP facility
Familiarity and understanding of basic and/or advanced cGMP compliance in the biotech/bioprocessing manufacturing environment
Knowledge of Code of Federal Regulations 21 CFR 1271 a plus
Detail-oriented, self-motivated and scientifically driven
Strong analytical and problem-solving skills
Strong knowledge of GMP quality systems
Excellent communication and interpersonal skills
General Competencies:
Able to communicate effectively in English, both verbally and in writing
Excellent communication and interpersonal skills
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 Mechanical Engineering, Electrical Engineering, Chemical Engineering, or similar field, required
At least 3 years of industry experience in process and equipment automation
At least 3 years of relevant pharma or biotech industry experience
Experience with automation platforms including Allen-Bradley PLC, DeltaV DCS, Beckhoff TwinCAT PLC and/or Johnson Controls
Experience installing and/or supporting PI historian system
Background in Automation, Electrical Engineering or Mechanical Engineering
Knowledge and experience with standard bioprocessing skills as well as use and maintenance of common laboratory procedures and equipment
Will spend time in a clean room environment for manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines
Apr 24, 2024
Full time
Position Background:
The Automation Engineer 2 is responsible for supporting any existing and new project automation systems at Humacyte, an FDA regulated site. This includes daily verifications required for data integrity requirements and modifications to the system configuration as required for process, building or historian automation requirements. There is an expectation that the employee will have a primary system responsibility, either DeltaV, PLC, BAS, or PI focused, but will be able to support all automation system as required .
Remote Work Designation : Not Remote
Major Accountabilities:
Utilizing current engineering skills and knowledge, provide routine automation expertise for the development of custom commercial manufacturing equipment for a human acellular vessel product with the guidance and direction of more senior team members and/or manager
Support and maintain existing PI data historian in existing manufacturing and R&D facilities
In collaboration with Senior Automation Engineer and/or Associate Director, Automation, support the installation and validation of a PI data historian for the commercial manufacturing facility
Support the installation and validation of a DeltaV system for the commercial manufacturing process
Support the installation and validation a building automation system for the commercial manufacturing facility
Support the installation and validation of OEM and custom PLCs for the commercial manufacturing process
Assist process development team in testing prototype equipment and by independently developing automation for custom research and development equipment
Promote transparency around process development activities through routine internal updates to direct manager and/or cross-functional colleagues
Support and troubleshooting automation during development, technology transfer, and commercial manufacturing
Perform thorough system tests to ensure robustness of custom automation
Assist in oversight in transition of automated equipment to comply with regulatory and quality control requirements
Assist in the development of automation documentation, including functional requirements, design documents, test protocols, SOPs and reports
Respond to automation-based alarms during standard office hours and as on-call support, as required
Support regulatory filings as required
Other duties, as assigned
Special Competencies:
Demonstrated knowledge and understanding of developing and supporting automation for commercial manufacturing processes
Familiarity with automation of bioprocess applications in GMP facility
Familiarity and understanding of basic and/or advanced cGMP compliance in the biotech/bioprocessing manufacturing environment
Knowledge of Code of Federal Regulations 21 CFR 1271 a plus
Detail-oriented, self-motivated and scientifically driven
Strong analytical and problem-solving skills
Strong knowledge of GMP quality systems
Excellent communication and interpersonal skills
General Competencies:
Able to communicate effectively in English, both verbally and in writing
Excellent communication and interpersonal skills
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 Mechanical Engineering, Electrical Engineering, Chemical Engineering, or similar field, required
At least 3 years of industry experience in process and equipment automation
At least 3 years of relevant pharma or biotech industry experience
Experience with automation platforms including Allen-Bradley PLC, DeltaV DCS, Beckhoff TwinCAT PLC and/or Johnson Controls
Experience installing and/or supporting PI historian system
Background in Automation, Electrical Engineering or Mechanical Engineering
Knowledge and experience with standard bioprocessing skills as well as use and maintenance of common laboratory procedures and equipment
Will spend time in a clean room environment for manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines
Service Technician II position includes the following responsibilities: service, maintenance, troubleshooting, testing and general repairs of MQ’s construction equipment. Employee is able to complete most duties and responsibilities with minor or no “how-to” instructions or supervision.
Responsibilities:
Preventative Maintenance and Repair
Perform preventative maintenance on power generation equipment according to Multiquip’s established guidelines and service/maintenance schedules.
Accurately troubleshoot and diagnose standard power generation equipment.
Knowledge to perform standard repairs on power generation equipment and related supporting accessories; replace supporting accessories when required.
Removes, disassembles, assembles, and installs components and parts; including mechanical, electrical and hydraulic components.
Inspection and repair of all supporting systems such as fuel, cooling, and mechanical systems.
DOT Inspection and repair of all trailers manufactured by Multiquip Inc. DOT certification testing is available to the employee for this job function.
Properly setup and test equipment utilizing proper testing procedures while utilizing safe operation practices.
Cuts, route, comb, twist, tie wrap, and attaches wire to terminal points, according to layout, using soldering gun and hand tools and is able to connect wiring to accessories, such as relays, circuit breakers, plugs, switches, solenoids, etc.
Prepares and completes service reports in a precise and timely manner as required.
Must be able to communicate technical matters clearly, both written and verbally.
Inventory Management and Administrative Tasks
Ability to track and manage employee’s specific inventory during inspection and repair processes.
Request equipment and or supplies for the purpose of maintaining inventory and ensuring availability of the items required to complete necessary jobs.
Participates in meetings and trainings as assigned for the purpose of conveying or gathering information required to perform job functions.
Performs all work in accordance with Multiquip’s established quality standards along with all safety procedures and maintains a clean and safe working environment.
Ability to operate and utilize standard computer programs such as all Microsoft Office tools, Adobe Acrobat, web-based service tools and reporting tools.
Collaboration and Support
This position will work with other service technicians to ensure all work scheduled is performed safely and to the customer's satisfaction. Technicians ability to assist senior level technicians as needed is required.
Performs other duties as assigned by the employees’ manager/supervisor.
Qualifications
Education and/or Work Experience Requirements:
High school diploma or (GED) equivalent;
Minimum of 3 years of experience on current (2020 and newer) power generation equipment.
Diesel engine generator/Electrical troubleshooting experience required.
Skills, Abilities and Tooling:
We are looking for a dedicated individual who is a team player with a positive attitude.
Is mechanically inclined and able to complete assigned tasks with minimal or no supervision.
Has great overall understanding of complex and/or logical functions.
Has the ability to travel to job sites for repairs as needed.
Has strong problem-solving skills and is detailed oriented with a high level of accuracy.
Is able to read and interpret documents such as equipment and environment safety rules, operating and maintenance instructions as well as written procedures to include troubleshooting flow charts and equipment service manuals.
Must have all standard tooling to complete repairs.
Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to stand. The employee frequently is required to use hands to finger, handle, or feel and talk or hear, kneel, crouch or crawl. The employee will occasionally lift and/ or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus.
Compensation and Benefits
Pay wage: $28/hr + DOE
Shift: Day Shift (7am-3:30pm) M-F
Competitive compensation, including Annual Bonuses & Merit Increases
11 paid Holidays
Generous Paid Time Off - Accrues at a rate of 4 weeks per year to start
Paid volunteer Time Off
Paid Parental Leave
Excellent Benefits Package for Full Time Employee that starts the 1st of the month after 30 days of hire date including:
Medical, Dental, Vision, Life Insurance, Disability, Flex Spending, Accidental Insurance, Critical Illness Insurance, Hospital Indemnity Insurance, & Legal insurance
Retirement Planning - 401(k) plan including Discretionary Company Match
Tuition Reimbursement up to $5,250 a year
Employee Referral Program
Employee Assistance Program
Apr 04, 2024
Full time
Service Technician II position includes the following responsibilities: service, maintenance, troubleshooting, testing and general repairs of MQ’s construction equipment. Employee is able to complete most duties and responsibilities with minor or no “how-to” instructions or supervision.
Responsibilities:
Preventative Maintenance and Repair
Perform preventative maintenance on power generation equipment according to Multiquip’s established guidelines and service/maintenance schedules.
Accurately troubleshoot and diagnose standard power generation equipment.
Knowledge to perform standard repairs on power generation equipment and related supporting accessories; replace supporting accessories when required.
Removes, disassembles, assembles, and installs components and parts; including mechanical, electrical and hydraulic components.
Inspection and repair of all supporting systems such as fuel, cooling, and mechanical systems.
DOT Inspection and repair of all trailers manufactured by Multiquip Inc. DOT certification testing is available to the employee for this job function.
Properly setup and test equipment utilizing proper testing procedures while utilizing safe operation practices.
Cuts, route, comb, twist, tie wrap, and attaches wire to terminal points, according to layout, using soldering gun and hand tools and is able to connect wiring to accessories, such as relays, circuit breakers, plugs, switches, solenoids, etc.
Prepares and completes service reports in a precise and timely manner as required.
Must be able to communicate technical matters clearly, both written and verbally.
Inventory Management and Administrative Tasks
Ability to track and manage employee’s specific inventory during inspection and repair processes.
Request equipment and or supplies for the purpose of maintaining inventory and ensuring availability of the items required to complete necessary jobs.
Participates in meetings and trainings as assigned for the purpose of conveying or gathering information required to perform job functions.
Performs all work in accordance with Multiquip’s established quality standards along with all safety procedures and maintains a clean and safe working environment.
Ability to operate and utilize standard computer programs such as all Microsoft Office tools, Adobe Acrobat, web-based service tools and reporting tools.
Collaboration and Support
This position will work with other service technicians to ensure all work scheduled is performed safely and to the customer's satisfaction. Technicians ability to assist senior level technicians as needed is required.
Performs other duties as assigned by the employees’ manager/supervisor.
Qualifications
Education and/or Work Experience Requirements:
High school diploma or (GED) equivalent;
Minimum of 3 years of experience on current (2020 and newer) power generation equipment.
Diesel engine generator/Electrical troubleshooting experience required.
Skills, Abilities and Tooling:
We are looking for a dedicated individual who is a team player with a positive attitude.
Is mechanically inclined and able to complete assigned tasks with minimal or no supervision.
Has great overall understanding of complex and/or logical functions.
Has the ability to travel to job sites for repairs as needed.
Has strong problem-solving skills and is detailed oriented with a high level of accuracy.
Is able to read and interpret documents such as equipment and environment safety rules, operating and maintenance instructions as well as written procedures to include troubleshooting flow charts and equipment service manuals.
Must have all standard tooling to complete repairs.
Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to stand. The employee frequently is required to use hands to finger, handle, or feel and talk or hear, kneel, crouch or crawl. The employee will occasionally lift and/ or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus.
Compensation and Benefits
Pay wage: $28/hr + DOE
Shift: Day Shift (7am-3:30pm) M-F
Competitive compensation, including Annual Bonuses & Merit Increases
11 paid Holidays
Generous Paid Time Off - Accrues at a rate of 4 weeks per year to start
Paid volunteer Time Off
Paid Parental Leave
Excellent Benefits Package for Full Time Employee that starts the 1st of the month after 30 days of hire date including:
Medical, Dental, Vision, Life Insurance, Disability, Flex Spending, Accidental Insurance, Critical Illness Insurance, Hospital Indemnity Insurance, & Legal insurance
Retirement Planning - 401(k) plan including Discretionary Company Match
Tuition Reimbursement up to $5,250 a year
Employee Referral Program
Employee Assistance Program