Bristol-Myers Squibb Company

Validation Engineer (Re#: 1030)

Location
Devens, MA, US
Posted
Oct 06, 2018
Ref
R1510589
Required Education
Masters Degree/MBA
Position Type
Full time
Employer: Bristol-Myers Squibb Company

Position: Validation Engineer (Re#: 1030)

Location: 38 Jackson Road, Devens, MA 01434

Duties: Utilize experience with writing, executing and documentation of validation protocols, large scale distributed control systems, and project management, and knowledge of system life cycle validation techniques for automation software specification and development, SOPs, cGMPs and other compliance requirements and regulatory guidelines (FDA, EU), and management within a regulatory environment to lead the testing of required configuration changes to the BMS industrial production site process automation system. Lead the testing of process recipes in the BMS industrial production site manufacturing execution system. Lead validation activities arising from change controls, capital projects, shutdown/changeover activity, and ongoing revalidation programs at BMS industrial production sites. Develop appropriate validation methodologies in collaboration with Operations management and Quality Assurance for novel industrial production projects. Maintain a portfolio of validation projects under strict deadlines to ensure stakeholder success and bulk drug supply production. Lead multiple industrial engineering projects and technical work assignments while serving as a point of contact for project stakeholders. Provide validation subject matter expertise to multi-function teams, advise Operations on validation matters, and present adequate compliance evidence before industrial production regulatory agencies. Ensures alignment with BMS directives and industry guidelines on validation and industrial production. Support internal industrial production compliance and efficiency improvement efforts within the pharmaceutical department.

Requirements: Master's degree in Pharmaceutical Sciences, Chemical Engineering or a related field plus 2 years of post-baccalaureate experience with biopharmaceutical / pharmaceutical processing including testing and /or developing process automation system software reflecting demonstrable ability in the skills set described above. Alternatively, employer will accept a Bachelor's degree in Pharmaceutical Sciences, Chemical Engineering or a related field plus 6 years of post-baccalaureate experience with biopharmaceutical / pharmaceutical processing including testing and /or developing process automation system software reflecting demonstrable ability in the skills set described above.

** This position is eligible for our employee referral program