Associate Process Engineer
12-Month+ Contract | 1st Shift | Monday-Friday, 8:00 AM-5:00 PMET| ONSITE
Our client, a Global Leader in the Medical Device Industry, has an immediate opening for an Associate Process Engineer for a 12-month+ contract. Our client offers results-driven people a place where they can make a difference - every day! You will also have the opportunity to work with other like-minded, self-directed and detail-oriented Top Talents in an extremely collaborative and professional environment.
Key Responsibilities:
- Developing and modifying process formulations, methods, and controls to meet quality standards.
- Recommending and implementing improvements, modifications, and additions to process documentation.
- Reviewing product development requirements for compatibility with processing methods and determining costs and schedules.
- Integrating equipment and material capabilities to meet process module and technology target specifications.
- Drafting and executing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for production lines and equipment.
- Collecting, compiling, and analyzing experimental and process data using statistical methods and authoring clear, concise validation reports.
- Supporting the evaluation of Engineering Change Orders (ECOs) and process modifications to determine validation impacts and execution requirements.
- Drafting and updating work instructions, preventive maintenance procedures, and equipment operating manuals based on validated parameters.
Requirements:
- Mechanical engineering background suitable for an entry-level process engineering role.
- Strong technical writing skills, particularly for SOPs and validation documentation.
- Ability to work effectively under pressure and collaborate with other engineers.
- Hands-on, mechanically inclined approach.
- Experience with OnePLM or Windchill.
- Validation experience.
- Design review experience.
