Validation Specialist â Aseptic Process Simulation Synerfac Technical Staffing
Whippany, NJ21 days ago
- $42–$45 Per Hour
- Temporary
- Contractor
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Skills
- Asepsisunmatched
- Assembly Lineunmatched
- Best Practicesunmatched
- Biologyunmatched
- Continuous Improvementunmatched
- Cross-Functionalunmatched
- Current Good Manufacturing Practice (cGMP)unmatched
- Drug Manufacturingunmatched
- FDA Requirementsunmatched
- GMP (Good Manufacturing Practices)unmatched
- Maintain Complianceunmatched
- Manufacturingunmatched
- Manufacturing/Industrial Processesunmatched
- Process Developmentunmatched
- Process Engineeringunmatched
- Process Improvementunmatched
- Process Validationunmatched
- Project Executionunmatched
- Regulatory Complianceunmatched
- Requirements Validation/Verificationunmatched
- Risk Analysisunmatched
- Sales Qualificationunmatched
- Team Playerunmatched
- Technical Supportunmatched
- Technical Writingunmatched
- Validation Planunmatched
- Writing Skillsunmatched
Description
Job Description:
- We are seeking an experienced Process Validation Engineer to support new pharmaceutical manufacturing projects within a sterile GMP environment. This role will focus on process validation, technology transfer, and qualification activities for pre-filled syringe (PFS) manufacturing lines. The ideal candidate will have strong experience with aseptic processing, PPQ execution, and cross-functional collaboration to ensure successful project delivery and regulatory compliance.
- Develop and execute process validation strategies for new and existing sterile manufacturing processes.
- Lead Process Performance Qualification (PPQ) activities for pre-filled syringe (PFS) fill lines.
- Support technology transfer projects, ensuring seamless implementation of manufacturing processes across production lines.
- Coordinate and evaluate aseptic media fill studies to verify process performance and compliance.
- Perform process revalidation activities and maintain validated manufacturing processes.
- Support smoke studies and qualification activities for automated visual inspection systems.
- Collaborate with Manufacturing, Quality, Validation, Engineering, and external partners throughout project execution.
- Prepare and review validation protocols, reports, risk assessments, and technical documentation.
- Ensure compliance with cGMP, FDA regulations, and industry best practices.
- Provide technical support for investigations, process improvements, and continuous improvement initiatives.
- Bachelor's degree in engineering, Life Sciences, or a related discipline.
- Experience in Process Validation within a pharmaceutical or sterile manufacturing environment.
- Hands-on experience with Technology Transfer and PPQ execution.
- Strong knowledge of aseptic manufacturing, media fills, and sterile processing.
- Experience supporting smoke studies and qualification activities.
- Excellent technical writing, communication, and cross-functional collaboration skills.
- Working knowledge of FDA regulations, cGMP, and validation lifecycle requirements.
Numbers & Facts
| Location | Newark, NJ |
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