Process Engineer, Clinical Supply Operations, OSD Manufacturing

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 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.

Clinical Supply Operations (CSO)

Our Clinical Supply Operations is responsible for the supply of drug product administered to patients in clinical studies worldwide. In Global Product Development and Supply the team works closely with our partners to deliver quality products safely, efficiently and on time while operationalizing the innovative technologies that will deliver the transformative medicines of tomorrow. As a member of our team, you will get the chance to play a pivotal role to positively impact patients’ lives while developing professionally to achieve your own career goals.

Position Description:

The candidate will be responsible for the proper operation of the process equipment and facility supporting the CSO oral solid dosage manufacturing operation. 

Responsibilities include:

• Support process development and scale up activities associated with production of GMP and non-GMP material.
• Assist with training on the continuous manufacturing equipment (CDC-50 unit operation) to OSD operators and supervisors as well as scientists from DPD.
• Via collaboration with DPD and other functions, facilitate the technology transfer of Drug Product from Drug Product Development (DPD) to Oral Solid Dosage (OSD).
• Assists with management of equipment qualification, the process equipment preventive maintenance program and instrument calibrations.
• Provides hands on support on the Continuous Manufacturing, Spray Dryer and assists in qualification activities and operation for new and existing equipment where applicable.
• Assists with the execution of routine Preventive Maintenance and ad hoc work orders performed by in-house personnel as well as through equipment vendor visits.
• Responsible for contributing to quality investigations, change controls and generation of SOPs related to equipment operation.

Position Requirements:

• Bachelor’s Degree in life sciences, engineering, or related discipline with at least 5 years of relevant experience or demonstrated hands on experience working with oral solid dosage process equipment with at least 5 years of experience.  Continuous manufacturing strongly desired.
• The candidate should have the ability to read equipment and construction drawings (i.e. P&IDs, layout drawings, electrical drawings, etc.).
• Experience should include factory site acceptance testing, development and application of project specifications, startup and qualification.

• A background in automation technology as it relates to process equipment would be beneficial.  Familiarity with Maximo, Veeva or similar operating systems is a plus.

• The successful candidate must have strong oral and written communications skills with demonstrated ability to author GMP documentation (SOPs, Change Control, Deviations, Risk Assessments etc.).

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 wher