Bristol Myers Squibb
Senior Specialist, Equipment Commissioning & Qualification
Bristol Myers Squibb, Trenton, New Jersey, United States
Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. Position Summary
The Senior Specialist supports the successful operation of facilities, laboratories, and business functions at multi-use sites through interaction with internal team members and peer-level customers as well as external service providers. Role & Responsibilities
Author, review, approve, and execute equipment qualification protocols, plans, summary reports, protocol deviations, and other validation deliverables as required. Author, review, and approve equipment risk assessments, system categorization assessments, and change control impact assessments. Propose, present, and execute change controls for equipment introduction, modification, and retirement. Review and approve calibration plans, preventative maintenance schedules, system criticality/classification assessments, alarm assessments, and asset change requests. System Ownership
Procure new CQV equipment and implement associated procedures to support process equipment qualifications. Create, revise, and periodically review procedural documents for CQV equipment. Coordinate system usage to maintain CQV timelines while adhering to system calibration and maintenance schedules. Perform data integrity risk assessments, audit trail reviews, and user access reviews for CQV equipment. Compliance and Regulatory Responsibilities
Lead and support workflows related to quality events and actions including deviations, investigations, proactive initiatives, and corrective and preventive actions. Create, revise and periodically review CQV program SOPs and associated work instructions/practices. Administer and perform system periodic reviews and CQV document periodic reviews, and review/approve corresponding deliverables. Ensure manufacturing and laboratory equipment is maintained in a validated state in compliance with GMP, BMS standards, and health authority regulations. Qualifications & Experience
BS in an Engineering/Science discipline required or minimum of 6 years of experience leading equipment qualifications. Minimum of 6 years of experience in FDA-regulated industry. Minimum of 4 years of experience developing and executing equipment qualifications, process validations, and/or test method validations. Strong background and experience in laboratory and manufacturing operations, with advanced knowledge of cGMP pharmaceutical manufacturing and associated process equipment utilized for cell therapy clinical manufacturing. Experience executing temperature/humidity mapping qualifications for controlled storage areas and/or controlled temperature units. Compensation Overview: Warren - NJ - US $86,490 - $104,803 Bristol Myers Squibb offers a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.
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Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. Position Summary
The Senior Specialist supports the successful operation of facilities, laboratories, and business functions at multi-use sites through interaction with internal team members and peer-level customers as well as external service providers. Role & Responsibilities
Author, review, approve, and execute equipment qualification protocols, plans, summary reports, protocol deviations, and other validation deliverables as required. Author, review, and approve equipment risk assessments, system categorization assessments, and change control impact assessments. Propose, present, and execute change controls for equipment introduction, modification, and retirement. Review and approve calibration plans, preventative maintenance schedules, system criticality/classification assessments, alarm assessments, and asset change requests. System Ownership
Procure new CQV equipment and implement associated procedures to support process equipment qualifications. Create, revise, and periodically review procedural documents for CQV equipment. Coordinate system usage to maintain CQV timelines while adhering to system calibration and maintenance schedules. Perform data integrity risk assessments, audit trail reviews, and user access reviews for CQV equipment. Compliance and Regulatory Responsibilities
Lead and support workflows related to quality events and actions including deviations, investigations, proactive initiatives, and corrective and preventive actions. Create, revise and periodically review CQV program SOPs and associated work instructions/practices. Administer and perform system periodic reviews and CQV document periodic reviews, and review/approve corresponding deliverables. Ensure manufacturing and laboratory equipment is maintained in a validated state in compliance with GMP, BMS standards, and health authority regulations. Qualifications & Experience
BS in an Engineering/Science discipline required or minimum of 6 years of experience leading equipment qualifications. Minimum of 6 years of experience in FDA-regulated industry. Minimum of 4 years of experience developing and executing equipment qualifications, process validations, and/or test method validations. Strong background and experience in laboratory and manufacturing operations, with advanced knowledge of cGMP pharmaceutical manufacturing and associated process equipment utilized for cell therapy clinical manufacturing. Experience executing temperature/humidity mapping qualifications for controlled storage areas and/or controlled temperature units. Compensation Overview: Warren - NJ - US $86,490 - $104,803 Bristol Myers Squibb offers a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.
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