What are the responsibilities and job description for the Process Engineer position at Stark Pharma Solutions Inc?
Hi,
My name is Sravani Dasari from Stark Pharma Solutions Inc. We are hiring talent for our client and are currently working on a Process Engineer position. Please send me your updated resume if you have relevant experience and are interested in this opportunity. The detailed job description is as follows.
Job Title: Process Engineer
Location: Richmond, IL
Duration: Long Term
Position Overview
We are seeking a Process Engineer to support process validation, risk management, and engineering activities within a regulated manufacturing environment. This role will focus on validation execution, design documentation, risk assessments, process improvements, and cross-functional project coordination while ensuring compliance with quality and regulatory requirements.
Key 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.
• Coordinate with cross-functional teams on equipment installation and validation activities.
• Perform risk assessments and identify opportunities for process improvements.
• Support 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.
Required Qualifications
• 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.
I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.
Please follow Stark Pharma Solutions on LinkedIn for the latest job updates: https://www.linkedin.com/company/99455976/