Process Engineer I

2 days ago


Waltham, Massachusetts, United States DPS Group Global Full time
Job Title: Process Engineer I

DPS Group Global is seeking a highly skilled Process Engineer I to join our team. As a Process Engineer I, you will be responsible for ensuring the operability and reliability of GMP manufacturing process equipment located at manufacturing facilities.

Key Responsibilities:
  • Installation and startup testing of new equipment
  • Ownership of system P&IDs - responsible for engineering review, walkdowns, redlines & system changes
  • Generation, review, and approval of engineering lifecycle documentation for assigned systems
  • Review, approval, and execution support of C&Q protocols for assigned systems
  • Generation, review, and approval of engineering change management for assigned systems
  • New systems troubleshooting floor support
  • Provide direct engineering support and Subject Matter Expertise for process equipment such as: Ultrafiltration, Chromatography, TMIX, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Fermenters, Reaction Vessels, etc...
  • Skills required to meet expectations of the role include high-quality technical writing within the required quality systems and meeting the project timelines to ensure the production schedule is not impacted
  • Provide daily, on-the-floor support to manufacturing
  • Facilitate tech transfer, process fit, and facility fit for new projects
  • Support the team goal of achieving gold standard batches and right the first-time processing
  • Troubleshoot equipment to determine root cause of failure modes, independently drive failure resolution, owning Corrective/Preventative Actions and associated change controls
  • Own quality records such as Change Controls, Deviations, and CAPAs, related to manufacturing process equipment, as required
  • Provide input into preventative maintenance plans, assessing change controls, and continuous improvement initiatives
Requirements:
  • 0-3 Years experience in a GMP manufacturing/engineering environment and a B.E. / B.S. degree in Chemical Engineering
  • Must have previous Biotech or Biopharmaceutical industry experience working in a process engineering role
  • Must have strong knowledge and experience supporting cleaning (CIP, COP, glass washers, detergent distribution), sterilization (SIP, autoclaves), bench top analytics (Cedex, Nova, filter integrity testers), and single use systems
  • Good report and technical writing skills with the ability to drive changes in a cross-functional team environment
  • Experience with all aspects of biotech and pharmaceutical industries
  • Demonstrates good interpersonal skills, is attentive and approachable
  • Maintains a professional and productive relationship with area management and co-workers
  • Ability to provide legal US work authorization documents required. Will consider US domestic travelers and relocation

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