About the Role:
The Process Validation Engineer plays a critical role in ensuring that manufacturing processes consistently produce products that meet predetermined quality standards and regulatory requirements. This position involves designing, executing, and documenting validation protocols to confirm that processes are robust, reliable, and capable of producing high-quality outputs. The engineer will collaborate closely with cross-functional teams including manufacturing, quality assurance, and research and development to identify process improvements and troubleshoot issues. A key outcome of this role is to provide comprehensive validation reports and technical documentation that support regulatory submissions and internal quality audits. Ultimately, the Process Validation Engineer ensures that manufacturing processes are optimized for efficiency, compliance, and product safety within the manufacturing environment in the United States.
Core Technical Skillsets
Automated Liquid Handling & Robotics
- Hands-on experience commissioning and validating automated liquid handling systems, including:
- Integra Biosciences Assist Plus
- Art Robbins Instruments Gryphon
- Tecan Liquid Handlers
- Beckman Coulter Biomek FXp
- Ability to develop, modify, and troubleshoot liquid handling programs involving:
- Complex loop logic (high-iteration aspirate/dispense cycles)
- Long runtime protocols (1–3+ hours)
- Multi-program product families
- Understanding of liquid classes, pipetting accuracy/precision, and cross-contamination risks.
Commissioning & Validation Execution
- Strong experience executing commissioning, IOQ, OQ, and PQ activities for laboratory equipment.
- Proven ability to:
- Draft, execute, and approve commissioning protocols and reports
- Draft, execute, and approve PQ protocols and reports
- Update existing IOQ/OQ protocols to align with site standards and equipment configurations
- Comfortable validating multiple identical systems (e.g., Gryphon #1–#4, Integra Assist #2a–#2c) with consistency and traceability.
Validation Documentation & Compliance
- Expert-level GMP documentation skills, including:
- Equipment Specifications (URS / ES)
- Commissioning protocols & reports
- IOQ/OQ/PQ protocols & reports
- Familiarity with FDA and global regulatory expectations for lab automation and analytical equipment.
- Ability to support protocol approvals, deviations, and data integrity requirements.
Specialized / High-Value Experience (Strongly Preferred)
Analytical & Measurement Systems
- Validation experience with:
- Advanced Instruments Artel Multichannel Verification System (liquid volume verification)
- Agilent Technologies BioTek 800 TS or similar ELISA microplate readers
- Understanding of volume verification, calibration concepts, and measurement system suitability.
Cross-Functional & Operational Readiness
- Experience completing and documenting operator training as part of PQ readiness.
- Ability to work closely with:
- Lab operations
- QA
- Automation engineers / vendors
- Comfortable supporting high equipment throughput across multiple product families.
Behavioral & Project Execution Requirements
- Highly organized; capable of managing many parallel validation workstreams.
- Strong attention to detail across repetitive yet critical execution tasks.
- Self-directed and comfortable owning deliverables end-to-end (draft → execute → approve).
- Clear technical writer with strong protocol and report authorship skills.
