Process Engineer
Stark Pharma Solutions Inc · Richmond, IL · 2 wk ago
On-siteManagementFull-time
Job Title
About the role
The Process Engineer will support process validation, risk management, and engineering activities within a regulated manufacturing environment.
Responsibilities
- Lead and coordinate process validation activities, including IQ, OQ, and PQ execution.
- Develop, review, and maintain engineering and validation documentation.
- Author and review risk management documents, including Process FMEA (pFMEA).
- Support design transfer activities and process implementation projects.
- Cook up with cross-functional teams on equipment installation and validation activities.
- Perform risk assessments and identify opportunities for process improvements.
- Sustain statistical analysis, Design of Experiments (DOE), and Test Method Validation (TMV) activities.
- Collaborate with Quality, Manufacturing, and Engineering teams to ensure project success.
- Ensure compliance with design controls, quality systems, and regulatory requirements.
Requirements
- Bachelor's Degree in Engineering or a related technical discipline.
- 2+ years of engineering experience within a regulated industry.
- Hands-on experience with Process Validation (IQ/OQ/PQ).
- Experience with Risk Management methodologies, including FMEA.
- Knowledge of ISO 13485 and quality system requirements.
- Familiarity with design controls and engineering documentation.
- Understanding of statistical analysis, DOE, and validation principles is preferred.
- Proficiency with Microsoft Office applications.
- Strong problem-solving, communication, and project coordination skills.
Qualifications
Commensurate with experience.
Skills
Not specified.
Benefits
N/A
Pay
TBD
Schedule
TBD
Benefits
N/A
Contact
Please follow Stark Pharma Solutions on LinkedIn for the latest job updates: https://www.linkedin.com/company/99455976/