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Process Engineer I

2 months ago


Waltham, Massachusetts, United States DPS Group Global Full time

About the Role

We are seeking a highly skilled Process Engineer I to join our team at DPS Group Global. As a Process Engineer I, you will play a critical role in ensuring the operability and reliability of GMP manufacturing process equipment at our facilities.

Key Responsibilities

  • Installation and startup testing of new equipment, including generation, execution, and close-out of engineering test plans.
  • Ownership of system P&IDs, responsible for engineering review, walkdowns, redlines, and 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.
  • Collaboration with Equipment SMEs, MS&T, and equipment End Users to investigate and troubleshoot issues related to process equipment.
  • Provide direct engineering support and Subject Matter Expertise for process equipment, including 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 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.
  • Other duties as assigned.

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.

Additional Skills Required

  • Continuous Learning –Assesses own strengths and weaknesses. Pursues training and development opportunities. Seeks feedback to improve performance. Shares expertise with others. Strives to continuously build knowledge and skills.
  • Culture - Supports a culture of excellence. Contributes to a collaborative environment that rewards teamwork, mentorship, best-in-practice development, and pride in workmanship.
  • Customer Services – Displays courtesy and sensitivity. Manages difficult or emotional customer situations. Meets commitments. Responds promptly to customer needs. Solicits customer feedback to improve service.
  • Planning and Organizing – Prioritizes and Plans work activities. Uses time efficiently. Plans for additional resources. Integrates changes smoothly, Sets goals and objectives. Works in an organized manner.
  • Teamwork – Balances team and individual responsibilities. Contributes to building a positive team spirit. Exhibits objectivity and openness to others' views. Gives and welcomes feedback. Puts success of team above own interests.
  • Use of Technology – Demonstrates required skills. Adapts to new technologies. Keeps technical skills up to date. Troubleshoots technological problems. Uses technology to increase productivity.
  • Language Ability - Read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Write routine reports and correspondence. Speak effectively before groups of customers or employees.
  • Mathematical Ability - Work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Apply concepts such as fractions, percentages, ratios and proportions to practical situations.
  • Reasoning Ability - Apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Deal with problems involving several concrete variables in standardized situations.