Senior Manufacturing Engineer

Bristol-Myers Squibb Company in Devens, MA

  • Type: Full Time
position filled
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Major Duties and Responsibilities:
Provide engineering support of automated manufacturing production equipment for both upstream and downstream processes. Equipment to be supported include, but are not limited to, bioreactors, depth filters, centrifugation, column chromatography and ultrafiltration/diafiltration (UFDF) systems.
Responsible for support of clean in place (CIP), steam in place (SIP) and process operations for several unit operations.
Work cross functionally to support the Manufacturing, Quality, Automation and Validation teams through execution of change control and ownership of CAPA and safety action plans.
Support safety initiatives and medium/high risk investigation activities across the site.
Support maintenance activities including review of preventative maintenance (PM), engineering drawing updates, and out of tolerance investigations for calibration of critical equipment.
Lead small capital projects and support large capital projects, including user requirement definition, installation, commissioning, and validation activities (IQ, OQ, PQ) ensuring equipment meets functional and user requirements. Ensure adherence to site/company engineering specifications.
Technical expert for equipment changes, ensuring robust operations and continued compliance of the manufacturing equipment.

Knowledge and Skill Requirements:
Knowledge generally attained through studies resulting in a B.S. in engineering (Chemical or Mechanical preferred), a related discipline or equivalent.
5-10 years of experience (or equivalent) working in a cGMP manufacturing setting including direct support of manufacturing equipment and processes.
The individual should have the ability to organize and manage multiple small but complex technical projects, and should have demonstrated effectiveness working in both a team environment as well as an individual contributor role.
Knowledge / expertise of engineering and operational principles of biopharmaceutical manufacturing equipment such as bioreactors, centrifugation, chromatography, UF/DF, CIP and SIP. Knowledge of DeltaV is highly desirable. Ability to use process data to troubleshoot equipment and automation is required.
Core competencies include a deep technical understanding of process flow and biopharmaceutical manufacturing equipment operation, ability to collect and analyze data for in depth investigative activities, and a basic understanding of process/equipment design, in addition to strong ability to work individually and as part of a team.
Ability to work extended hours or a modified work schedule is required for coverage of 24/7 manufacturing operations. The position is Monday through Friday, first shift, but requires on call availability.
Typical daily activities are office based. Engineers are also required to work within the manufacturing facility where industrial manufacturing setting hazards are present, and PPE is required.
Direction and decision making is aligned with supervisor.
Will work on assignments which are technical and complex in nature, and where a high degree of initiative is required. Problem resolution and recommendation development is done with minimal oversight from supervisor.

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 the resources to pursue their goals, both at work and in their personal lives.

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