SR MANUFACTURING ENGINEER(Job Number: 1203217)
1. Responsible for Engineering support and ownership required for specified manufacturing production equipment. 2. Partner with and be responsible for defining user requirements for new equipment including supporting installation. 3. Lead site GEPOV CIP, SIP, and/or Riboflavin startup activities. 4. During future capital projects the Manufacturing Engineer will work with Manufacturing (Quality and Construction) organizations providing CQV support of process equipment and systems including on-the-floor troubleshooting of equipment. 5. Project Management (as required) of small capital projects. 6. During construction of future projects responsibilities will include supporting the LSCC project group with design reviews, assistance in preparation of specifications, execution and evaluation of factory acceptance tests for manufacturing equipment, assessment of spare part requirements, assist in the generation of PM activities, and walk down of equipment systems prior to handover. Operation Focus: 1. Technical expert for equipment changes ensuring continued compliance of the manufacturing equipment. 2. Periodic FMEA review of owned equipment. 3. Perform but not be limited to the following activities: Periodic FMEA review of owned equipment,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 Deviations CAPA and change management and contamination investigations
- The successful candidate will have, at a minimum, a BS or Masters in Engineering (Chemical or Mechanical preferred) with 8 years plus (or equivalent) experience with manufacturing equipment design 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.
- Significant Process and Engineering design knowledge with typical biopharmaceutical upstream and downstream processing and support equipment including but not limited to scale up and large scale bioreactors, filtration and ultra filtration, CIP, SIP, centrifugation, chromatography, autoclaves, and glass washers.
- Experience with 3D model plant design software desirable.
- Candidates must be effective in both a team environment and an individual contributor role.
- Knowledgeable in engineering principles related to CIP, SIP Process Biopharmaceutical process troubleshooting.
- Candidate must be available for up to 25% percent travel which is likely to occur during future startup operations.
- Ability to work extended hours or a modified work schedule as required for coverage of start up activities for future projects and support of ongoing 24/7 Support, Chromatography, Ultra filtration UFDF, CIP, and SIP.
Job Function: Engineering
Primary Location: NA-US-MA-Devens
: Tech Op - Biologics Devens
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