Biopharmaceutical Project Engineer

Overview

Primary responsibility of the Project Engineer will be to work with the engineering team to ensure operational and maintenance readiness for new equipment and facility modifications of manufacturing facility expansion. Candidate should be able to organize asset and spare parts details from documentation, draft assessments, and preventative maintenance job plans, collaborate with system owner and metrology to complete calibration forms, submit requests for implementation in the computerized maintenance management system (CMMS).

Responsibilities

  • Organizing asset information from turnover packages and commissioning and qualification teams to complete all required fields for new asset creation in the CMMS
  • Compiling provided bill of materials (BOM)/comprehensive parts lists from turnover packages and commissioning and qualification teams into organized spreadsheets and completing all fields required for inventory item creation in the CMMS
  • Leading collaborative reviews with GxP Facility Operations, Facilities Engineering, Reliability Engineering and Quality Assurance representatives for job plan development and revisions
  • Drafting assessments for new direct impact systems and drive review sessions with subject matter experts to determine component level criticality
  • Collaborating and driving calibration forms to approval with key stakeholders
  • Creating requests to implement new assets, job plans, PMs, spare parts and datasheets in the CMMS
  • Collaborating cross-functionally with system owners, quality assurance to address any comments during CMMS request process and driving CMMS requests to closure

Experience

  • Relevant 2-5 years’ experience within pharmaceutical/biologics manufacturing
  • BS in Engineering
  • Team player and a quick learner

Regarding your application
Please know that every application is carefully reviewed by our Leadership team. We understand and appreciate your efforts in the preparation of an application, so we will thoughtfully review and respond.