Process Engineer
Bristol-Myers Squibb
Process Engineer
Job Description
Act as SME for processes being technology transferred into the BMS Leiden Cell Therapy Facility. Prepare for and own process validation activities. Continuously monitor, analyze, and optimize the end-to-end process and anticipate and permanently resolve issues that may arise during production. Provide technical input and act as lead investigator for process related deviations, ensuring compliance with internal standards and regulatory requirements. Author, review and approve the content of technical documentation (e.g. investigations, changes, SOPs and batch records, protocols and reports) Acts as SME and leads interactions on behalf of MSAT during production campaigns in both the shopfloor and Front-Line Support. Provide prompt input on resolution of events occurring during manufacturing. Responsible for troubleshooting. Support the change initiatives and the implementation of process improvement initiatives. Drive and own change controls and change actions and be responsible with MSAT impact assessments. Bachelor's degree in relevant science or engineering discipline. Advanced degree preferred. Preferably 5 or more years of manufacturing support or related experience in the biopharmaceutical industry (preferably in MSAT, manufacturing or process development roles). Advanced Knowledge of facility/clean room design, process design or equipment, automation. Hands-on experience with single-use technologies, closed systems, or cold chain/cryogenic technologies. Experience with the start-up, process transfer or set up of the new manufacturing facilities.
About the Role/Company
- The company operates a Cell Therapy Facility in Leiden
- The role is within the MSAT (Manufacturing Science and Technology) department
Key Responsibilities
- Act as SME for processes being technology transferred into the BMS Leiden Cell Therapy Facility
- Prepare for and own process validation activities
- Continuously monitor, analyze, and optimize the end-to-end process
- Anticipate and permanently resolve issues that may arise during production
- Provide technical input and act as lead investigator for process related deviations
- Ensure compliance with internal standards and regulatory requirements
- Author, review and approve the content of technical documentation (e.g., investigations, changes, SOPs, batch records, protocols, and reports)
- Lead interactions on behalf of MSAT during production campaigns in both the shopfloor and Front-Line Support
- Provide prompt input on resolution of events occurring during manufacturing
- Responsible for troubleshooting
- Support the change initiatives and the implementation of process improvement initiatives
- Drive and own change controls and change actions
- Be responsible with MSAT impact assessments
Required Qualifications
- Bachelor's degree in relevant science or engineering discipline
Preferred Qualifications
- Advanced degree
- or more years of manufacturing support or related experience in the biopharmaceutical industry
- Experience in MSAT, manufacturing or process development roles
- Advanced Knowledge of facility/clean room design, process design or equipment, automation
- Hands-on experience with single-use technologies, closed systems, or cold chain/cryogenic technologies
- Experience with the start-up, process transfer or set up of new manufacturing facilities
Skills Required
- Technical expertise in process engineering
- Strong analytical and problem-solving skills
- Ability to lead and manage technical investigations
- Effective communication and documentation skills
- Ability to work collaboratively with various teams
Locations
- Leiden – NL, United States
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
75,000 - 120,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Technical expertise in process engineeringintermediate
- Strong analytical and problem-solving skillsintermediate
- Ability to lead and manage technical investigationsintermediate
- Effective communication and documentation skillsintermediate
- Ability to work collaboratively with various teamsintermediate
Required Qualifications
- Bachelor's degree in relevant science or engineering discipline (experience)
Preferred Qualifications
- Advanced degree (experience)
- or more years of manufacturing support or related experience in the biopharmaceutical industry (experience)
- Experience in MSAT, manufacturing or process development roles (experience)
- Advanced Knowledge of facility/clean room design, process design or equipment, automation (experience)
- Hands-on experience with single-use technologies, closed systems, or cold chain/cryogenic technologies (experience)
- Experience with the start-up, process transfer or set up of new manufacturing facilities (experience)
Responsibilities
- Act as SME for processes being technology transferred into the BMS Leiden Cell Therapy Facility
- Prepare for and own process validation activities
- Continuously monitor, analyze, and optimize the end-to-end process
- Anticipate and permanently resolve issues that may arise during production
- Provide technical input and act as lead investigator for process related deviations
- Ensure compliance with internal standards and regulatory requirements
- Author, review and approve the content of technical documentation (e.g., investigations, changes, SOPs, batch records, protocols, and reports)
- Lead interactions on behalf of MSAT during production campaigns in both the shopfloor and Front-Line Support
- Provide prompt input on resolution of events occurring during manufacturing
- Responsible for troubleshooting
- Support the change initiatives and the implementation of process improvement initiatives
- Drive and own change controls and change actions
- Be responsible with MSAT impact assessments
Tags & Categories
Process Engineer
Bristol-Myers Squibb
Process Engineer
Job Description
Act as SME for processes being technology transferred into the BMS Leiden Cell Therapy Facility. Prepare for and own process validation activities. Continuously monitor, analyze, and optimize the end-to-end process and anticipate and permanently resolve issues that may arise during production. Provide technical input and act as lead investigator for process related deviations, ensuring compliance with internal standards and regulatory requirements. Author, review and approve the content of technical documentation (e.g. investigations, changes, SOPs and batch records, protocols and reports) Acts as SME and leads interactions on behalf of MSAT during production campaigns in both the shopfloor and Front-Line Support. Provide prompt input on resolution of events occurring during manufacturing. Responsible for troubleshooting. Support the change initiatives and the implementation of process improvement initiatives. Drive and own change controls and change actions and be responsible with MSAT impact assessments. Bachelor's degree in relevant science or engineering discipline. Advanced degree preferred. Preferably 5 or more years of manufacturing support or related experience in the biopharmaceutical industry (preferably in MSAT, manufacturing or process development roles). Advanced Knowledge of facility/clean room design, process design or equipment, automation. Hands-on experience with single-use technologies, closed systems, or cold chain/cryogenic technologies. Experience with the start-up, process transfer or set up of the new manufacturing facilities.
About the Role/Company
- The company operates a Cell Therapy Facility in Leiden
- The role is within the MSAT (Manufacturing Science and Technology) department
Key Responsibilities
- Act as SME for processes being technology transferred into the BMS Leiden Cell Therapy Facility
- Prepare for and own process validation activities
- Continuously monitor, analyze, and optimize the end-to-end process
- Anticipate and permanently resolve issues that may arise during production
- Provide technical input and act as lead investigator for process related deviations
- Ensure compliance with internal standards and regulatory requirements
- Author, review and approve the content of technical documentation (e.g., investigations, changes, SOPs, batch records, protocols, and reports)
- Lead interactions on behalf of MSAT during production campaigns in both the shopfloor and Front-Line Support
- Provide prompt input on resolution of events occurring during manufacturing
- Responsible for troubleshooting
- Support the change initiatives and the implementation of process improvement initiatives
- Drive and own change controls and change actions
- Be responsible with MSAT impact assessments
Required Qualifications
- Bachelor's degree in relevant science or engineering discipline
Preferred Qualifications
- Advanced degree
- or more years of manufacturing support or related experience in the biopharmaceutical industry
- Experience in MSAT, manufacturing or process development roles
- Advanced Knowledge of facility/clean room design, process design or equipment, automation
- Hands-on experience with single-use technologies, closed systems, or cold chain/cryogenic technologies
- Experience with the start-up, process transfer or set up of new manufacturing facilities
Skills Required
- Technical expertise in process engineering
- Strong analytical and problem-solving skills
- Ability to lead and manage technical investigations
- Effective communication and documentation skills
- Ability to work collaboratively with various teams
Locations
- Leiden – NL, United States
Salary
Salary not disclosed
Estimated Salary Rangemedium confidence
75,000 - 120,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Technical expertise in process engineeringintermediate
- Strong analytical and problem-solving skillsintermediate
- Ability to lead and manage technical investigationsintermediate
- Effective communication and documentation skillsintermediate
- Ability to work collaboratively with various teamsintermediate
Required Qualifications
- Bachelor's degree in relevant science or engineering discipline (experience)
Preferred Qualifications
- Advanced degree (experience)
- or more years of manufacturing support or related experience in the biopharmaceutical industry (experience)
- Experience in MSAT, manufacturing or process development roles (experience)
- Advanced Knowledge of facility/clean room design, process design or equipment, automation (experience)
- Hands-on experience with single-use technologies, closed systems, or cold chain/cryogenic technologies (experience)
- Experience with the start-up, process transfer or set up of new manufacturing facilities (experience)
Responsibilities
- Act as SME for processes being technology transferred into the BMS Leiden Cell Therapy Facility
- Prepare for and own process validation activities
- Continuously monitor, analyze, and optimize the end-to-end process
- Anticipate and permanently resolve issues that may arise during production
- Provide technical input and act as lead investigator for process related deviations
- Ensure compliance with internal standards and regulatory requirements
- Author, review and approve the content of technical documentation (e.g., investigations, changes, SOPs, batch records, protocols, and reports)
- Lead interactions on behalf of MSAT during production campaigns in both the shopfloor and Front-Line Support
- Provide prompt input on resolution of events occurring during manufacturing
- Responsible for troubleshooting
- Support the change initiatives and the implementation of process improvement initiatives
- Drive and own change controls and change actions
- Be responsible with MSAT impact assessments
Tags & Categories