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.

Position summary:

Reporting to the Senior Manager, or designee, the CQV Engineer performs duties required to support validation activities for Leiden Cell Therapy Facility and ensures protocols and reports are in compliance with BMS requirements. This member will be responsible for executing and coordinating Installation, Operational and Performance qualification (IQ/OQ/PQ) activities when required.

Responsibilities:

- Write protocols, perform field executions, and create final reports for Analytical Instruments/Equipment/utilities/facilities system qualifications.

- Communicate progress effectively.

- Ensure process and project documentation is accurate and updated.

- Maintain safe working environment.

- Follow company policies and procedures.

- Ensure accuracy of data presented in protocols and reports.

- Ensure data is recorded / reviewed using good documentation practices (GDP).

- Ensure calibration of equipment used for validation activities is up to date.

- Interfaces with customers to ensure all expectations are being met.

- Works collaboratively with Manufacturing, Technical Manufacturing, Manufacturing Technology, Facilities & Engineering and Quality.

- Coordinate and communicate with area owners to ensure completion of requalification and qualification activities.

- Perform requalification/revalidation activities as necessary.

- Ensure process and project documentation is accurate and updated.

- Provide input to Validation Services department SOPs review activities.

- Engage in and contribute to continuous improvement projects.

Qualifications:

- BS in Engineering or Science related discipline preferred with a minimum of 1-3 years’ experience performing and/or supporting pharmaceutical application validation in a GMP environment.

- Strong problem-solving skills, strong verbal and written communication skills, and the ability to work independently.

- Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements, EU GMP Annex 15, and good documentation practices.

- Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.

- Experience or close familiarity with analytical instruments/equipment/utility/facility qualifications and general commissioning, qualification and validation practices are desired.

- Experience collaborating with multi-functional teams.

- Excellent communication and technical writing skills are required.

- No travel requirements.