Process Engineer

3 weeks ago


Rochester, Michigan, United States Endo International Full time

Job Summary

We are seeking a highly skilled Process Engineer to join our team at Endo International. The successful candidate will be responsible for optimizing and analyzing production processes, new products, processes, and technology transfers.

Key Responsibilities

  • Prepare and execute engineering study protocols, manufacturing and packaging experimental / feasibility study / validation batch records and protocols.
  • Complete interim and / or final summary reports for marketed and new products.
  • Perform or assist on-site and site-change technical transfer, scale-up or scale-down factor evaluation, manufacturing / packaging process and equipment troubleshooting, and SOP preparation and review.
  • Coordinate with Facilities, Engineering, Manufacturing, Packaging, Product Development, Analytical Services, RA, and QA to initiate manufacturing and packaging experimental / feasibility study / validation projects for marketed and new products.

Requirements

  • BS degree in Engineering or Chemical Engineering preferred with 3+ years' related experience.
  • Working knowledge of Current Good Manufacturing Practices (cGMP), FDA, OSHA, EPA, DEA; other regulatory requirements.
  • Working knowledge of Pharmaceutical manufacturing principles, practices and applications.
  • Understanding of concepts of equipment qualification/calibration.
  • Understanding of computer validation concepts.
  • Basic/Intermediate statistical computations (Cp, Cpk, regression analysis, etc.); use of statistical software.
  • Personal computer operations and MS applications (Word, Access, Excel, PowerPoint, MS Project).

Preferred Qualifications

  • Knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
  • Coaching, negotiation, calibration, technical writing etc.

Physical & Mental Requirements

Employee is frequently exposed to moving mechanical parts, and occasionally exposed to outside weather conditions and risk of electrical shock.

Commitment to Diversity, Equity, and Inclusion

At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person's unique perspective.


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