At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
The Validation Operations Engineer performs validation and qualification activities. He/She assures compliance of these activities with cGMP as well as with internal policies and procedures. The Validation Operations Engineer has demonstrated experience in managing validation projects, on time, and within budget. He/She is authorized to direct external vendors performing work in this field.Skills/Knowledge Required
Duties and Responsibilities
- BS/MS in Engineering/Technical discipline or equivalent experience
- 5 years of experience in pharmaceutical Validation or related field
- Familiarity 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
- Knowledge of pharmaceutical facilities, manufacturing, and laboratory systems
- Automation knowledge advantageous
- Communicates proactively and collaboratively
- Team player: ability to interact effectively with team and customers
- Good written & oral communication skills in French and English
- May be assigned Subject Matter Expert role for a defined validation/qualification area.
- Develop and justify the validation approach based on risk and scientific rational
- Ensure equipment, systems and processes are qualified, validated and maintained in compliance with local policies, guidelines, and procedures during their lifecycle.
- Author and when required review validation documents, including requirement specifications, validation plans, protocols, reports, traceability matrix and summary reports.
- Execute qualifications for all equipment and systems across the site, including QC, production, warehouse, facilities, equipment, utilities and computer system validation, excluding global IT systems.
- Execute validations for all processes across the site, including cleaning processes, bulk process, packaging processes and warehouse/sampling processes.
- Contributes to the development and maintenance of the local site procedures.
- Lead risk assessments and risk management teams
- Review change controls and maintenance interventions, evaluating the impact upon qualified systems & validated processes, and documents required actions
- Manage validation projects; including managing time, resources and budgets; own associated change controls.
- Co-ordinate qualification and validation execution activities, including external vendors and internal departments.
- Participate when required during internal and external audits for which they are a Subject Matter Expert, by answering questions, reviewing qualifications and validations with auditors, and providing documentation.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.