Senior Specialist, QC Support, Cell Therapy

Bristol-Myers Squibb; Harvard (MA); Vor Ort; USD 91.000 - 110.000; Vollzeit

Zusammenfassung

Bristol Myers Squibb is seeking a Senior Specialist to manage QC equipment lifecycle activities and serve as the system owner for QC equipment. You will create user requirements, validation protocols, and essential documentation while coordinating with QC labs, Site Engineering, and Facility Services.

The role requires 4+ years in a regulated lab, strong knowledge of cGMP, and experience with SAP/Valgenesis/Maximo.

Qualifikationen

• Bachelor’s degree or equivalent required, preferably in science.
• Advanced degree preferred; Netherlands: MLO level 4 required.
• 4+ years of relevant laboratory experience or equivalent.
• Advanced knowledge of computerized systems and enterprise applications such as SAP, Valgenesis and Maximo preferred.
• Demonstrated technical writing skills.
• Working knowledge of data integrity principles preferred.
• Demonstrated experience with equipment qualification and validation.
• Knowledge of cGMP and regulatory requirements.

Aufgaben

• Manage the lifecycle activities of QC laboratory equipment. May serve as the QC equipment system owner.
• Create equipment User Requirement, validation protocols and equipment related documents.
• Collaborate with QC laboratories, Site Engineering, Facility Services, and other departments for the commissioning and decommissioning of laboratory equipment.
• Schedule, facilitate and participate in performing the qualification, calibration, maintenance, repairs of QC laboratory equipment, whether performed internally or by vendors.
• Maintain equipment records in accordance with GMP requirements and written procedures.
• Maintain electronic equipment database, equipment logs, equipment status metrics, and applying equipment status labels.
• Anticipate and perform routine troubleshooting and problem solving with minimal guidance.
• Train and mentor others on equipment lifecycle process and procedures as applicable.
• Perform document revision, project, CAPA and deviation/ investigation, change management actions, related tasks and/ or continuous improvement efforts.
• Review GMP documentation/ records, including vendor executed validation documents for GDP adherence.
• Perform other tasks as required to support the QC laboratories.

Kenntnisse

Regulatory knowledge

Problem solving

Communication

Teamwork

Technical writing

Data integrity

Equipment qualification

Quality systems

Ausbildung

Bachelor’s degree or equivalent

Advanced degree preferred

MLO level 4 (Netherlands)

Tools

SAP

Valgenesis

Maximo

Jobbeschreibung

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Position Summary

The Senior Specialist position manages the lifecycle activities of QC laboratory equipment. May serve as the QC equipment system owner.

Duties/Responsibilities

• Manage the lifecycle activities of QC laboratory equipment. May serve as the QC equipment system owner.
• Create equipment User Requirement, validation protocols and equipment related documents.
• Collaborate with QC laboratories, Site Engineering, Facility Services, and other departments for the commissioning and decommissioning of laboratory equipment.
• Schedule, facilitate and participate in performing the qualification, calibration, maintenance, repairs of QC laboratory equipment, whether performed internally or by vendors.
• Maintain equipment records in accordance with GMP requirements and written procedures.
• Maintain electronic equipment database, equipment logs, equipment status metrics, and applying equipment status labels.
• Anticipate and perform routine troubleshooting and problem solving with minimal guidance.
• Train and mentor others on equipment lifecycle process and procedures as applicable.
• Perform document revision, project, CAPA and deviation/ investigation, change management actions, related tasks and/ or continuous improvement efforts.
• Review GMP documentation/ records, including vendor executed validation documents for GDP adherence.
• Perform other tasks as required to support the QC laboratories.

Reporting Relationship

• This position will report to QC management.

Qualifications

Specific Knowledge, Skills, Abilities:

• Ability to accurately and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements.
• High problem-solving ability/mentality, technically adept and logical.
• Ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs.
• Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
• Bachelor’s degree or equivalent required, preferably in science.
• Advanced degree preferred. Netherlands: MLO level 4 required.4+ years of relevant laboratory experience or equivalent combination of education and experience, preferably in a regulated environment.Advanced knowledge of computerized systems and enterprise applications such as SAP, Valgenesis and Maximo preferred.
• Demonstrated technical writing skills.
• Working knowledge of data integrity principles preferred.
• Demonstrated experience with equipment qualification and validation.

Compensation Overview:

Devens - MA - US: $91,180 - $110,488

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits:

• Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
• U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
• Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
• Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
• U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working. (https://careers.bms.com/life-at-bms/ways-of-working/)

Supporting People with Disabilities

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. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail] . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

For roles based in Washington State only: If you live in or expect to work from Washington State if hired for this position, please visit this page (https://www.atg.wa.gov/fair-chance-act) for important information about the Washington Fair Chance Act.

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection .

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

R1607709 : Senior Specialist, QC Support, Cell Therapy

Req Number:

R1607709

Location:

Devens - Massachusetts - US

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.