Merck KGaA-posted 2 months ago
Full-time • Mid Level
Jaffrey, NH
1,001-5,000 employees
Chemical Manufacturing

The Process Engineer II is an intermediate level engineering position responsible for supporting the manufacture and testing of high purity filters, prioritizing safety and maintaining a focus on quality, process control, electro-mechanical assembly, and material handling. Responsible for establishing operating specifications and implementing and improving manufacturing techniques. Closely monitors performance of machinery, automated equipment, and tools to verify their efficiency and investigates and initiates corrective action for challenging problems and deficiencies to ensure product quality. This position ensures process stability with a focus on maximizing safety, quality, yields, and productivity and requires collaboration with cross functional team to assess risk, disposition product, and resolve problems.

  • Proficient at maintaining efficiency and upkeep of critical manufacturing equipment through effective troubleshooting techniques.
  • Able to diagnose and resolve intermediate level process problems.
  • Exchanges ideas with other team members and leads technical discussions to realize process improvements and changes.
  • Leads decision making by building consensus among cross functional peers.
  • Proficient at evaluating and implementing process improvements or changes and driving a cross functional team to meet deadlines.
  • Takes responsibility for intermediate level Process Engineering assessments and uses data to ensure appropriate disposition of product.
  • Provides or leads process support on Root Cause Analysis (RCA) and Corrective Action Preventive Action (CAPA) actions.
  • Strong technical writing skills and solid understanding of Current Good Manufacturing Practices (cGMP).
  • Generates, reviews and approves engineering, manufacturing and quality procedures necessary to support equipment validation/revalidation.
  • Leads/reviews capital equipment fabrication activities to ensure manufacturing, installation, and operational testing conform to industry standards.
  • Leads capital equipment purchases, providing robust justification, establishing timeline for execution and spend activities.
  • Coordinates equipment and process validations activities, including protocol and report writing, review and execution.
  • Designs and develops manufacturing processes that demonstrate high levels of statistical control.
  • Leads change requests in Change Management system, ensuring implementation solutions support operational needs and meet quality standards.
  • Facilitates effective teamwork in own field by working with colleagues at all levels.
  • Helps develop less-experienced team members by giving concrete advice, coaching or mentoring.
  • Advances methods/systems to characterize processes and prevent failure modes and scrap risk.
  • Able to navigate roadblocks or challenges that occur during the course of implementation.
  • Bachelor's Degree in STEM (engineering, sciences, or computer science, etc.), technical management, or business management or related.
  • 2+ years of experience in an FDA regulated medical device manufacturing facility, pharmaceutical facility or other regulated industry supporting automated or manual assembly processes.
  • Masters of Science Degree in Electrical, Mechanical, Chemical or Industrial Engineering.
  • Electro-Mechanical, instrument and pneumatic knowledge along with 3+ years of experience applying this knowledge to process/equipment design and/or troubleshooting.
  • Proven ability to analyze intermediate level data sets, apply statistical analysis principles, and clearly summarize conclusions/results.
  • Familiarity with EH&S, ISO, cGMP, and other regulatory requirements in a manufacturing environment.
  • Ability to read and understand intermediate level mechanical and electrical drawings and P&IDs.
  • Experience with Microsoft products, Minitab, and CAD software packages.
  • Understand safe work practices and experience in lockout, tag out, electrical safety, etc.
  • Lean/Six Sigma experience, with green or black belt.
  • Strong communication skills.
  • We are committed to creating access and opportunities for all to develop and grow at your own pace.
  • Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress.
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