My Next Stage
Senior Specialist, Equipment Commissioning & Qualification
My Next Stage, 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. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
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. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here at BMS with our Cell Therapy team.
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. The position focus is on providing technical expertise and decision making while ensuring end-to-end and timely completion of Process Equipment projects and ongoing work activities of low to moderate complexity, individually and with support of others. Role & Responsibilities:
The Senior Specialist supports the Commissioning, Qualification, and Validation team as an individual contributor to: 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. Provide input and feedback for change strategy, qualification approach, compliance gaps, and risk mitigation. Review and approve calibration plans, preventative maintenance schedules, system criticality/classification assessments, alarm assessments, and asset change requests within the computerized maintenance management system. System Ownership Procure new CQV equipment and implement associated procedures to support process equipment qualifications. Train new users to operate CQV equipment and troubleshoot as needed. Create, revise, and periodically review procedural documents for CQV equipment such as temperature and humidity mapping systems, CO2 instruments, and LN2 foggers. 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. Periodically update the CQV validated systems list. Ensure manufacturing and laboratory equipment is maintained in a validated state in compliance with GMP, BMS standards, and health authority regulations. Serve as a subject matter expert for equipment qualification in internal and regulatory audits. Qualifications & Experience
The Senior Specialist contributes essential skills, competencies, and experience necessary for equipment commissioning and qualification, including: 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 (incubators, refrigerators, freezers, cryogenic storage systems) is required. Highly preferred experience designing and performing airflow visualization studies for biological safety cabinets, isolators, and controlled/classified areas. Preferred experience commissioning and qualifying isolators and filling/capping equipment, with a technical background and basic understanding of operation and changeover of aseptic fill/finish technology. Process oriented with strong problem solving and critical thinking skills. Adaptive and able to develop new and improved strategies, approaches, and procedures. Excellent technical writing skills and proficiency with Microsoft Word formatting functions. Detail oriented and technically accurate author and reviewer of documents for system lifecycle deliverables in alignment with the site validation program. Strong multi‐tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a fast-paced environment and concurrently monitor tasks and assignments with others that may impact timely completion. Excellent communication and interpersonal skills; communicate effectively, efficiently, and in a timely manner. Experience dealing with a diverse workforce; team oriented and professionally mature. Highly proficient in Microsoft Office Suite – Word, Excel, PowerPoint and Outlook. Working knowledge of scheduling software, material inventory management systems, calibration/maintenance management systems, and environmental monitoring systems. Strong understanding of quality management systems, document management systems, records management, and data integrity principles. Experience interacting with external and/or internal auditors in a compliance audit environment, with direct interaction including face to face interaction in response to audit questions is preferred. Bristol Myers Squibb is an equal employment opportunity employer and is committed to providing equal employment opportunities to all applicants. We are dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations, and ongoing support in their roles. If you require a reasonable accommodation in completing this application, or in any part of the recruitment process, please direct your inquiries to
adastaffingsupport@bms.com . Visit
careers.bms.com/
eeo
-accessibility
to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
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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. The position focus is on providing technical expertise and decision making while ensuring end-to-end and timely completion of Process Equipment projects and ongoing work activities of low to moderate complexity, individually and with support of others. Role & Responsibilities:
The Senior Specialist supports the Commissioning, Qualification, and Validation team as an individual contributor to: 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. Provide input and feedback for change strategy, qualification approach, compliance gaps, and risk mitigation. Review and approve calibration plans, preventative maintenance schedules, system criticality/classification assessments, alarm assessments, and asset change requests within the computerized maintenance management system. System Ownership Procure new CQV equipment and implement associated procedures to support process equipment qualifications. Train new users to operate CQV equipment and troubleshoot as needed. Create, revise, and periodically review procedural documents for CQV equipment such as temperature and humidity mapping systems, CO2 instruments, and LN2 foggers. 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. Periodically update the CQV validated systems list. Ensure manufacturing and laboratory equipment is maintained in a validated state in compliance with GMP, BMS standards, and health authority regulations. Serve as a subject matter expert for equipment qualification in internal and regulatory audits. Qualifications & Experience
The Senior Specialist contributes essential skills, competencies, and experience necessary for equipment commissioning and qualification, including: 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 (incubators, refrigerators, freezers, cryogenic storage systems) is required. Highly preferred experience designing and performing airflow visualization studies for biological safety cabinets, isolators, and controlled/classified areas. Preferred experience commissioning and qualifying isolators and filling/capping equipment, with a technical background and basic understanding of operation and changeover of aseptic fill/finish technology. Process oriented with strong problem solving and critical thinking skills. Adaptive and able to develop new and improved strategies, approaches, and procedures. Excellent technical writing skills and proficiency with Microsoft Word formatting functions. Detail oriented and technically accurate author and reviewer of documents for system lifecycle deliverables in alignment with the site validation program. Strong multi‐tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a fast-paced environment and concurrently monitor tasks and assignments with others that may impact timely completion. Excellent communication and interpersonal skills; communicate effectively, efficiently, and in a timely manner. Experience dealing with a diverse workforce; team oriented and professionally mature. Highly proficient in Microsoft Office Suite – Word, Excel, PowerPoint and Outlook. Working knowledge of scheduling software, material inventory management systems, calibration/maintenance management systems, and environmental monitoring systems. Strong understanding of quality management systems, document management systems, records management, and data integrity principles. Experience interacting with external and/or internal auditors in a compliance audit environment, with direct interaction including face to face interaction in response to audit questions is preferred. Bristol Myers Squibb is an equal employment opportunity employer and is committed to providing equal employment opportunities to all applicants. We are dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations, and ongoing support in their roles. If you require a reasonable accommodation in completing this application, or in any part of the recruitment process, please direct your inquiries to
adastaffingsupport@bms.com . Visit
careers.bms.com/
eeo
-accessibility
to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
#J-18808-Ljbffr