Bristol-Myers Squibb Company

Manufacturing Engineer

Location
Devens, MA, US
Posted
Aug 01, 2018
Ref
R1508295
Required Education
Bachelors Degree
Position Type
Full time
Major Duties / Responsibilities

Provide Engineering support of automated manufacturing production equipment for both upstream and downstream processes. Included but not limited to bioreactors, depth filtration, centrifugation, column chromatography, and Ultrafiltration/diafiltration systems. Responsibilities include troubleshooting Clean in Place (CIP), Steam in Place (SIP), and process operations for a particular process step. Provide support to Manufacturing, Quality, Automation, and Validation for deviation investigation, change controls, and CAPA's through participation in cross functional team environment. Support Maintenance activities, including review and approval of Preventative Maintenance (PM), drawing updates, and support of out of Specification investigations related to Calibration of critical equipment. Support future capital projects from start to finish, including defining user requirements, supporting installation, commissioning, and Validation activities including IQ, OQ, PQ, ensuring equipment functions to current User requirement specifications. Ensure construction activities are performed to site specifications; PM programs are updated as needed, and perform design review (including Factory and Site acceptance testing as needed). Partner with and be responsible for defining user requirements for new equipment including supporting installation.

Operation Focus:
  • Technical expert for equipment changes ensuring continued compliance of the manufacturing equipment.
  • Perform but not be limited to the following activities: addressing equipment issues identified by production teams, assessing production needs opportunities, coordination with internal groups and outside contractors, generation of specifications for the procurement of equipment and Instrumentation, installation modification of equipment and systems, reducing equipment downtime, developing and implementing new capital project scopes, project management for non capital modification projects, support of compliance efforts related to Investigations, CAPA and change management.


Knowledge and Skill

The successful candidate will have a BS in Engineering (Chemical or Mechanical preferred) with 6 years plus experience (or equivalent) with manufacturing equipment support in the Biotechnology manufacturing industry.

The individual should have the ability to manage and organize multiple complex technical projects and familiarity with the manufacturing operations of large scale production facilities as well as GMP experience.

Knowledge/expertise of engineering principles related to and expertise with typical biopharmaceutical upstream and downstream processing and support equipment including but not limited to bioreactors, filtration and ultra filtration, CIP, SIP, centrifugation, chromatography, autoclaves, and glass washers.

Candidates must be effective in both a team environment and an individual contributor role.

Ability to work extended hours or a modified work schedule as required for coverage of 24/7 manufacturing operation. The position is Monday through Friday, first shift, but requires on-call availability. Knowledge of Delta V, or other process automation software desirable; ability to use process historian and analyze data to assist troubleshooting.