Senior Principal Engineer, Drug Product

at  BristolMyers Squibb

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.

QUALIFICATIONS & EXPERIENCE

• Minimum Bachelors degree in pharmaceutical, analytical, engineering or related sciences with at least 7 years of experience in pharmaceutical manufacturing, or development, and a solid record of achievement in roles of increasing responsibility
• Appropriate knowledge and experience across the key disciplines of process engineering, small molecules/oral solid dosage manufcturing, sterile process manufacturing and sterile process equipment design, commissioning and qualification in particular, as relevant to the role, as well as CMC and related FDA and international regulations
• Ability to anticipate industry trends and emerging issues
• Experience developing and implementing strategy to optimise processes and proactively manage risk
• Ability to develop and implement long term vision and strategy
• Ability to navigate complex matrix organisations
• Advanced knowledge of mechanical, utility, manufacturing, and other plant systems.
• Advanced knowledge of quality control systems, cGMP engineering design practices, equipment installation techniques including sustainability opportunities, OSHA regulations, and Factory Mutual requirements.
• Demonstrated skills at solving challenging technical issues with the ability to develop creative solutions.
• Demonstrated project leadership skills and effective decision-making abilities throughout a project while including key stakeholders.
  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.

THE ROLE

BMS Cruiserath Biologics is seeking to recruit on a permanent contract a Drug Product & Pharma Senior Principal Process Engineer. The Senior Principal Process Engineer will drive improvements in productivity and capability within the GPS Manufacturing network for Bio and Pharma divisions. The role will focus on finding new ways to increase site and network production output, efficiency, and reliability, and will serve as a key enabler of new product & technology introductions to the manufacturing sites. This role will report to the Director of MS&T Drug Product Process Analytics & Engineering, and will support the drug product and pharma manufacturing network, both internal and external. The DP Senior Principal Process Engineer will indirectly lead matrix teams of experienced scientists and process engineers.

KEY RESPONSIBILITIES

• Interface with stakeholders in MS&T, Process Development, and Operations, to identify opportunities for greater harmonization of equipment and automation capabilities across the Bio & Pharma network for increased supply chain agility & flexibility
• Conduct facility fit studies for new product introductions, including: equipment sizing and allocation, mass balances, facility dynamic capacity analysis, and schedule analysis
• Collaborate with Process Development to define process platforms and technical strategies that result in streamlined and agile product transfers along with robust and cost-effective commercial manufacturing
• Conceive of, and/or facilitate the application of innovative novel technologies into use within clinical and commercial manufacturing for improvements in GPS capabilities and competitiveness
• Drive identification, design, & prioritization of process optimization projects to deliver increased throughput, facility flexibility, yield improvement, and improved process capability at site and network level
• Specify, design, and oversee implementation of process equipment, systems, and associated process control methodologies, in direct support of commercial and clinical manufacturing operations
• Troubleshoot complex equipment and process-related issues escalated from operating sites
• Liaise with site leadership to align on strategic needs and initiative priorities
• Maintain Technology Map for sites and network
• Develops and maintains effective working relationships with other division groups in support of technology transfer, validation, productivity and process support activities, including equipment.
• Represents the MS&T at key technical forums.
• Oversees the ‘end to end’ management of equipment qualification, OEE and Equipment robustness.