ABOUT COMPANY:
Stark Pharma Solutions Inc is a life sciences staffing and consulting firm supporting pharmaceutical, biotechnology and medical device organizations across the United States. We place quality, validation, manufacturing and regulatory professionals with companies building and scaling FDA-regulated operations. Our clients range from established manufacturers to early-stage sites standing up their first quality systems.
Process Engineer Pharmaceutical (Process Validation, PPQ, cGMP)
JOB SUMMARY:
Our client, a pharmaceutical manufacturer, is seeking a Process Engineer to support cGMP manufacturing operations and process validation activities. The role covers day-to-day process support and troubleshooting, PPQ execution, deviation investigations and technology transfer, partnering with Manufacturing, Quality, MS&T and Engineering.
RESPONSIBILITIES:
- Provide day-to-day process engineering support to cGMP manufacturing operations and troubleshoot process issues
- Execute and support process validation and Process Performance Qualification (PPQ) activities
- Verify critical process parameters and equipment operating ranges
- Monitor process performance and support continued process verification (CPV)
- Review batch records and investigate process-related deviations to root cause
- Support technology transfer, scale-up and new product introduction activities
- Support equipment qualification (IQ/OQ/PQ) for process equipment
- Author and revise SOPs, batch records and process documentation
QUALIFICATIONS:
- Bachelor's degree in Chemical, Biomedical, Pharmaceutical or a related Engineering discipline
- 3 5 years of process engineering experience in cGMP pharmaceutical or biotech manufacturing
- Experience with process validation and Process Performance Qualification (PPQ)
- Working knowledge of cGMP and 21 CFR Part 210/211
- Understanding of critical process parameters (CPP) and critical quality attributes (CQA)
- Experience with deviations, investigations and CAPA
- Must be legally authorized to work in the United States
- W2 employment only