Senior Process Engineer

3 days ago


Kalamazoo, Michigan, United States JBL Resources Full time
Job Title: Senior Process Engineer

We are seeking a highly skilled Senior Process Engineer to join our team at JBL Resources. As a key member of our engineering team, you will be responsible for providing technical support for product transfers, ensuring that all activities are completed and documented in accordance with our company's latest procedures.

Key Responsibilities:
  • Providing engineering support for product transfers, ensuring compliance with company procedures.
  • Determining technical objectives of engineering assignments and making decisions regarding direction and results.
  • Monitoring and controlling progress of work, ensuring sound application of engineering principles and policies.
  • Analyzing equipment to establish operating data, conducting experimental tests, and result analysis.
  • Leading or acting as independent reviewer in process review meetings.
  • Coaching and mentoring others on functionally related topics.
  • Ensuring quality of process and product as defined in operation and material specifications.
  • Selecting components and equipment based on analysis of specifications, reliability, and regulatory requirements.
  • Working with quality engineers to develop component-specific testing and inspection protocols.
  • Participating in PFMEA, Control Plan, SOP, PPAP, and other internal process qualification generation associated with product transfers.
  • Ensuring adherence to GMP and safety procedures.
  • Reviewing and approving validation documentation.
  • Owning and supporting the development of validation plans for complex validation projects.
  • Owning and supporting validation and initial qualification of equipment and systems for NPI/Product Transfer activities.
  • Writing, reviewing, and executing studies for process validation, including DOE, OQ, and PQ.
Qualifications:
  • Bachelor's degree in an engineering discipline.
  • Minimum of 4 or more years' experience in an FDA-regulated manufacturing or project environment, with a preference for the medical device industry.
  • Experience with process/equipment validation - IQ/OQ/PQ, FAT/SAT testing.
  • Experience with statistical methods, process mapping, root cause analysis.
  • Experience coaching and mentoring team members, managing and coordinating projects, workstreams, and activities.
  • Experience with setup, programming, troubleshooting PLCs, ladder logic.
  • Experience sourcing new equipment - URS, RFQ, etc.
  • Ability to read and interpret complex engineering drawings and understand geometrical dimensioning and tolerancing.
  • Continuous Improvement and Project/Process Improvement related experience, preferred.
  • Green or Black Belt 6 Sigma qualifications, preferred.
  • Experience with SCADA systems, preferred.


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