Specialist, Associate Operations Engineer, Cell Therapy in Devens, MA
Bristol-Myers Squibb
Specialist, Associate Operations Engineer, Cell Therapy in Devens, MA
Job Description
Provides on-the-floor and on-site troubleshooting and technical support to Manufacturing and patient increase (RAMP) campaign support for variable shifts (Panama schedule, 0600 to 1800 or 1800 to 0600 variable shifting of days coverage) Facilitates deviation prevention and deviation closure through site quality systems Analyze and summarize manufacturing data to support impact assessments and investigations Owner of change controls for routine process and procedure changes CAPA owner for Manufacturing improvements Author and revise manufacturing SOPs and provide technical content and direction for electronic batch records Participates in technology transfer efforts for new processes and product implementation Train and support GMP operators on new procedures, processes, and changes Applies continuous improvement tools to identify and close procedural and compliance gaps Identify opportunities for process improvements and operational efficiencies, and lead implementation efforts. Interfaces with other functions such as Scheduling, Global MSAT, Supply Chain, Quality, and Facilities & Engineering Support equipment and systems validation activities, including review of equipment qualification documents, drafting user requirements, and participating on impact assessments Ability to perform gowning activities and enter the manufacturing plant. Exposure to strong magnetic fields is commonplace in the manufacturing areas. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. BSc and/or MSc degree in Science or Chem/Bio Engineering Minimum 1+ years of industry experience. cGMP and/or Cell Therapy manufacturing experience preferred
Key Responsibilities
- Provide on-the-floor and on-site troubleshooting and technical support to Manufacturing and patient increase (RAMP) campaign
- Facilitate deviation prevention and deviation closure through site quality systems
- Analyze and summarize manufacturing data to support impact assessments and investigations
- Own change controls for routine process and procedure changes
- Be CAPA owner for Manufacturing improvements
- Author and revise manufacturing SOPs and provide technical content and direction for electronic batch records
- Participate in technology transfer efforts for new processes and product implementation
- Train and support GMP operators on new procedures, processes, and changes
- Apply continuous improvement tools to identify and close procedural and compliance gaps
- Identify opportunities for process improvements and operational efficiencies, and lead implementation efforts
- Interface with other functions such as Scheduling, Global MSAT, Supply Chain, Quality, and Facilities & Engineering
- Support equipment and systems validation activities, including review of equipment qualification documents, drafting user requirements, and participating on impact assessments
Required Qualifications
- BSc and/or MSc degree in Science or Chem/Bio Engineering
- Minimum 1+ years of industry experience
Preferred Qualifications
- cGMP and/or Cell Therapy manufacturing experience
Skills Required
- Troubleshooting and technical support skills
- Data analysis and summarization skills
- Ability to author and revise SOPs
- Training and support skills for GMP operators
- Continuous improvement skills
- Ability to interface with multiple functions
- Skills in equipment and systems validation
Benefits & Perks
- Paid national holidays and optional holidays
- Global Shutdown Days between Christmas and New Year's holiday
- Up to 120 hours of paid vacation
- Up to two (2) paid days to volunteer
- Sick time off
- Summer hours flexibility
Additional Requirements
- Ability to work variable shifts (Panama schedule, 0600 to 1800 or 1800 to 0600)
- Ability to perform gowning activities and enter the manufacturing plant
- Willingness to work in areas with exposure to strong magnetic fields
Locations
- Devens MA, United States
Salary
Estimated Salary Rangemedium confidence
75,000 - 110,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Troubleshooting and technical support skillsintermediate
- Data analysis and summarization skillsintermediate
- Ability to author and revise SOPsintermediate
- Training and support skills for GMP operatorsintermediate
- Continuous improvement skillsintermediate
- Ability to interface with multiple functionsintermediate
- Skills in equipment and systems validationintermediate
Required Qualifications
- BSc and/or MSc degree in Science or Chem/Bio Engineering (experience)
- Minimum 1+ years of industry experience (experience)
Preferred Qualifications
- cGMP and/or Cell Therapy manufacturing experience (experience)
Responsibilities
- Provide on-the-floor and on-site troubleshooting and technical support to Manufacturing and patient increase (RAMP) campaign
- Facilitate deviation prevention and deviation closure through site quality systems
- Analyze and summarize manufacturing data to support impact assessments and investigations
- Own change controls for routine process and procedure changes
- Be CAPA owner for Manufacturing improvements
- Author and revise manufacturing SOPs and provide technical content and direction for electronic batch records
- Participate in technology transfer efforts for new processes and product implementation
- Train and support GMP operators on new procedures, processes, and changes
- Apply continuous improvement tools to identify and close procedural and compliance gaps
- Identify opportunities for process improvements and operational efficiencies, and lead implementation efforts
- Interface with other functions such as Scheduling, Global MSAT, Supply Chain, Quality, and Facilities & Engineering
- Support equipment and systems validation activities, including review of equipment qualification documents, drafting user requirements, and participating on impact assessments
Benefits
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
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Specialist, Associate Operations Engineer, Cell Therapy in Devens, MA
Bristol-Myers Squibb
Specialist, Associate Operations Engineer, Cell Therapy in Devens, MA
Job Description
Provides on-the-floor and on-site troubleshooting and technical support to Manufacturing and patient increase (RAMP) campaign support for variable shifts (Panama schedule, 0600 to 1800 or 1800 to 0600 variable shifting of days coverage) Facilitates deviation prevention and deviation closure through site quality systems Analyze and summarize manufacturing data to support impact assessments and investigations Owner of change controls for routine process and procedure changes CAPA owner for Manufacturing improvements Author and revise manufacturing SOPs and provide technical content and direction for electronic batch records Participates in technology transfer efforts for new processes and product implementation Train and support GMP operators on new procedures, processes, and changes Applies continuous improvement tools to identify and close procedural and compliance gaps Identify opportunities for process improvements and operational efficiencies, and lead implementation efforts. Interfaces with other functions such as Scheduling, Global MSAT, Supply Chain, Quality, and Facilities & Engineering Support equipment and systems validation activities, including review of equipment qualification documents, drafting user requirements, and participating on impact assessments Ability to perform gowning activities and enter the manufacturing plant. Exposure to strong magnetic fields is commonplace in the manufacturing areas. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. BSc and/or MSc degree in Science or Chem/Bio Engineering Minimum 1+ years of industry experience. cGMP and/or Cell Therapy manufacturing experience preferred
Key Responsibilities
- Provide on-the-floor and on-site troubleshooting and technical support to Manufacturing and patient increase (RAMP) campaign
- Facilitate deviation prevention and deviation closure through site quality systems
- Analyze and summarize manufacturing data to support impact assessments and investigations
- Own change controls for routine process and procedure changes
- Be CAPA owner for Manufacturing improvements
- Author and revise manufacturing SOPs and provide technical content and direction for electronic batch records
- Participate in technology transfer efforts for new processes and product implementation
- Train and support GMP operators on new procedures, processes, and changes
- Apply continuous improvement tools to identify and close procedural and compliance gaps
- Identify opportunities for process improvements and operational efficiencies, and lead implementation efforts
- Interface with other functions such as Scheduling, Global MSAT, Supply Chain, Quality, and Facilities & Engineering
- Support equipment and systems validation activities, including review of equipment qualification documents, drafting user requirements, and participating on impact assessments
Required Qualifications
- BSc and/or MSc degree in Science or Chem/Bio Engineering
- Minimum 1+ years of industry experience
Preferred Qualifications
- cGMP and/or Cell Therapy manufacturing experience
Skills Required
- Troubleshooting and technical support skills
- Data analysis and summarization skills
- Ability to author and revise SOPs
- Training and support skills for GMP operators
- Continuous improvement skills
- Ability to interface with multiple functions
- Skills in equipment and systems validation
Benefits & Perks
- Paid national holidays and optional holidays
- Global Shutdown Days between Christmas and New Year's holiday
- Up to 120 hours of paid vacation
- Up to two (2) paid days to volunteer
- Sick time off
- Summer hours flexibility
Additional Requirements
- Ability to work variable shifts (Panama schedule, 0600 to 1800 or 1800 to 0600)
- Ability to perform gowning activities and enter the manufacturing plant
- Willingness to work in areas with exposure to strong magnetic fields
Locations
- Devens MA, United States
Salary
Estimated Salary Rangemedium confidence
75,000 - 110,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Troubleshooting and technical support skillsintermediate
- Data analysis and summarization skillsintermediate
- Ability to author and revise SOPsintermediate
- Training and support skills for GMP operatorsintermediate
- Continuous improvement skillsintermediate
- Ability to interface with multiple functionsintermediate
- Skills in equipment and systems validationintermediate
Required Qualifications
- BSc and/or MSc degree in Science or Chem/Bio Engineering (experience)
- Minimum 1+ years of industry experience (experience)
Preferred Qualifications
- cGMP and/or Cell Therapy manufacturing experience (experience)
Responsibilities
- Provide on-the-floor and on-site troubleshooting and technical support to Manufacturing and patient increase (RAMP) campaign
- Facilitate deviation prevention and deviation closure through site quality systems
- Analyze and summarize manufacturing data to support impact assessments and investigations
- Own change controls for routine process and procedure changes
- Be CAPA owner for Manufacturing improvements
- Author and revise manufacturing SOPs and provide technical content and direction for electronic batch records
- Participate in technology transfer efforts for new processes and product implementation
- Train and support GMP operators on new procedures, processes, and changes
- Apply continuous improvement tools to identify and close procedural and compliance gaps
- Identify opportunities for process improvements and operational efficiencies, and lead implementation efforts
- Interface with other functions such as Scheduling, Global MSAT, Supply Chain, Quality, and Facilities & Engineering
- Support equipment and systems validation activities, including review of equipment qualification documents, drafting user requirements, and participating on impact assessments
Benefits
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
Tags & Categories
Answer 10 quick questions to check your fit for Specialist, Associate Operations Engineer, Cell Therapy in Devens, MA @ Bristol-Myers Squibb.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs