C&Q Engineer

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. Read more: careers.bms.com/working-with-us.

Max duration contract : 1 year

C&Q Engineer performs validation and qualification activities. She/He ensure compliance of these activities with cGMP as well as with internal policies and procedures.

She/He is authorized to direct external vendors performing work in this field.

Duties/Responsibilities :

• May be assigned Qualification/Re-qualification Lead role for a defined C&Q scope.
• Develop and justify the C&Q approach based on risk and scientific rational.
• Manage topics for continuous improvement in equipment risk analysis and periodic review processes.
• Lead risk assessments and Periodic review activities.
• Ensure equipment and systems are qualified, validated and maintained in compliance with local policies, guidelines, and procedures during their lifecycle.
• Author and when required review qualification documents, including requirement specifications, design qualification, qualification plans, protocols, reports, traceability matrix and qualification summary reports.
• Execute the re-qualification and periodic review activities maintaining qualified/Validated states of equipment, analytical instruments, utilities & facilities, and computerized system.
• Contributes to the development and maintenance of the local site procedures.
• Review/assess change controls and maintenance interventions, evaluating the impact upon qualified systems & validated processes, and documents required actions.
• Co-ordinate qualification and validation execution activities, including external vendors and internal departments.
• Participate in internal and external audits as SME, by answering questions, reviewing qualifications and validations with auditors, and providing documentation.
• Establish and maintain effective relationships with internal team, customers, and suppliers.
• Contributes to continuous improvement, including proactively identifying problems and proposing solutions.
• Autonomous; completes work independently, seeking guidance on complex tasks and on non-routine decisions.
• Participates in projects and initiatives as directed by their leader

Qualifications

• BS/MS in Engineering/Technical discipline or equivalent experience

Experience – Responsibility and minimum number of years

• min 1 year of experience in the pharmaceutical industry is mandatory.

Competencies – Knowledge, Skills Abilities:

• Strong Knowledge with current international regulatory regulations, cGxP requirements and best practices.
• Communicates pro-actively and collaboratively.
• Proactively identifies problems and recommends solutions Team player: ability to interact effectively with team and customers.
• Good level of English
• Ability to communicate in French is preferred

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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 a supportive culture, promoting global participation 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 an 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.

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 [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

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/

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.