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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. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. 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. Read more: careers.bms.com/working-with-us .

Position Summary

The Sr. Engineer Compliance owns and leads all the Technical Services team on all QA aspect to ensure the compliance within regulations and BMS site rules. He/she supports the Sr. Manager Methods, Engineering, Reliability and C&Q in monitoring quality and performance metrics.

He/She is the single contact point for Technical Services.

Duties/Responsibilities

• Coordinate QA Events for Technical Services team.

• Manage deviations, CAPAs, Change, IA, Findings, PI, QRA, DIRA investigations within TS teams.

• Act as a liaison between TS, MS&T and QA to ensure alignment on quality issues. (e.g. dev meetings Following and other QA share events)

• Maintain logs and documentation for quality events and ensure timely resolution.

• Prepare as coordinator and assist for internal and external cGxP audits, ensuring compliance.

• Quality Risk Management and Mitigation: Identify potential risks related to quality events within the technical services activities and work with teams to implement mitigation strategies.

• Quality Continuous Improvement Initiatives: Support or lead initiatives aimed at improving TS processes with a focus on enhancing quality compliance and operational efficiency.

• Qualification Knowledge for all QA events in qualification

• Training compliance: Ensure staff are trained on QA procedures and regulatory requirements.

• Ensure equipment and systems are qualified, validated and maintained in compliance with local policies, guidelines, and procedures during their lifecycle.

• Can review validation documents, including requirement specifications, qualification/validation plans, protocols, reports, traceability matrix and summary reports.

• Contributes to the development and maintenance of the local site procedures.

• Lead/Facilitate risk assessments and risk management teams.

• Review/assess change controls and maintenance interventions, evaluating the impact upon qualified systems & validated processes, and documents required actions.

• Support the team in proactively monitoring quality, safety and performance / reporting metrics (OEE, Tier Meeting).

• Autonomous; completes work independently, seeking guidance on complex tasks and on non-routine decisions.

Reporting Relationship

Sr. Manager Methods, Engineering, Reliability and C&Q

Qualifications

• BS/MS in Relevant science/Engineering/Technical discipline or equivalent in work experience

Experience - Responsibility and minimum number of years

• 5 years' QA experience in pharmaceutical industry

• 5 years' Manufacturing or technical experience on shopfloor

Competencies - Knowledge, Skills Abilities:

• Strong Knowlegde with current international regulatory regulations, cGxP requirements and best practices, including 21 CFR part 11, 210 and 211, Annex 11, EU-GMP guidelines and GAMP.

• Good ALCOA & Data Integrity knowledge

• Good knowledge on IT systems (Software and Hardware)

• Knowledge of pharmaceutical facilities (including HVAC and utilities), manufacturing and laboratory equipment/systems and computerized system validation (CSV)

• Knowledge of pharmaceutical qualification, calibration and maintenance activities

• Familiar with QA processes and compliance aspects.

• Communicates pro-actively and collaboratively.

• Proactively identifies problems and recommends solutions Team player: ability to interact effectively with team and customers.

• Good English level.

• Ability to communicate in French is preferred.

• Strong verbal and written communication skills.

• Strong analytical, problem solving, influential and deductive skills.

• Capability to work with short deadlines and simultaneous activities.

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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 adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) 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.

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

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/

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

Company: Bristol-Myers Squibb

Req Number: R1586900

Updated: 2024-12-17 05:25:16.637 UTC

Location: Boudry-CH

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.