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
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.
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