ELIQUENT Life Sciences · 18 hours ago
Process Validation Engineer
Los Angeles, CA
Contract
Onsite
Mid LevelELIQUENT Life Sciences is focused on ensuring that manufacturing processes meet quality standards and regulatory requirements. The Process Validation Engineer is responsible for designing, executing, and documenting validation protocols while collaborating with cross-functional teams to optimize processes for efficiency and compliance.
ConsultingMedical DeviceProfessional Services
Hiring Manager
Kevin O'Leary
Responsibilities
Designing, executing, and documenting validation protocols to confirm that processes are robust, reliable, and capable of producing high-quality outputs
Collaborating closely with cross-functional teams including manufacturing, quality assurance, and research and development to identify process improvements and troubleshoot issues
Providing comprehensive validation reports and technical documentation that support regulatory submissions and internal quality audits
Qualification
Required
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
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
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
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
Preferred
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
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
Company
ELIQUENT Life Sciences
ELIQUENT Life Sciences is a regulatory consulting firm for the life sciences industry.
501-1000 employees
H1B Sponsorship
ELIQUENT Life Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (29)
2024 (3)
Funding
Current Stage
Late StageLeadership Team
Stephen Purtell
Chief Financial Officer
Rob Wojciechowski
Chief Operating Officer
Recent News
2025-05-08
globallegalchronicle.com
2025-04-07
Company data provided by crunchbase