Bristol Myers Squibb Compliance Associate Engineer I/II in Devens, Massachusetts
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together, and driven to make a difference, from innovative research to hands-on community support. 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.
Reporting to the Compliance Manager, Devens Manufacturing Technology, the Compliance Associate Engineer, Manufacturing Technology, supports commercial manufacture of biopharmaceutical drug substance at Devens through Deviation Investigations and Quality Risk Management.
The Compliance Associate Engineer supports a large-scale, highly-automated cell culture and purification facility on a growing campus with many career development opportunities. This position offers the opportunity to provide highly visible deviation investigation and QRM support to resolve complex problems while meeting quality, schedule, and cost objectives. The successful candidate will be a key contributor in a dynamic and highly collaborative team environment. The candidate will be required to deliver on appropriate objectives and priorities, overcome obstacles, and deliver results within project timelines.
Conducts and manages resolution of Manufacturing deviations, root cause investigations, impact assessments and CAPAs as a Lead Investigator
Liaises with many different groups/organizations as a Lead Investigator
Proactively identifies and facilitates resolution of obstacles to timely completion
Proactively manages progression of investigation and CAPA to timely closure
Leads and participates in cross-functional investigation teams
Presents investigation findings to key stakeholders and site management
Uses Quality Risk Management and Operational Excellence principles to facilitate risk-based decision-making, drive continuous improvement, and eliminate waste
BS in chemical/biochemical engineering, biological sciences, or a related discipline with a minimum 2-4 years relevant experience (or equivalent)
Prior experience with SOPs, cGMPs and the know how to work within a regulatory environment required
Prior experience in/knowledge of cell culture, recovery, and/or purification of biopharmaceutical drug substance in a manufacturing environment required
Prior experience in leading cGMP investigations utilizing formal Root Cause Analysis tools strongly preferred
Demonstrated basic project management skills (organization, collaboration, multi-tasking and communication), attention to detail, and the ability to perform well in a team-based environment are required
Excellent verbal & written communications skills, including ability to present complex information clearly and concisely
Prior experience facilitating/participating in Risk Assessments preferred
Excellent interpersonal and collaboration skills necessary to interface with and influence all levels of the organization
Principal assignment is in a modern Large Scale Cell Culture building which requires adherence to various Personal Protective Equipment (PPE) standards.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled