ELIQUENT Life Sciences · 10 hours ago
Process Validation Engineer
Los Angeles, CA
Contract
Onsite
Mid LevelELIQUENT Life Sciences is focused on ensuring product quality and regulatory compliance in manufacturing processes. The Process Validation Engineer will design and execute validation protocols, collaborate with cross-functional teams, and produce detailed documentation to support quality audits and regulatory submissions.
ConsultingMedical DeviceProfessional Services
Hiring Manager
Kevin O'Leary
Responsibilities
Ensuring that manufacturing processes consistently produce products that meet predetermined quality standards and regulatory requirements
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
Optimizing manufacturing processes for efficiency, compliance, and product safety within the manufacturing environment
Qualification
Required
Bachelor's degree in Engineering, Biotechnology, or a related scientific discipline
Proven experience in process validation within a manufacturing environment, preferably in the pharmaceutical or biotech industry
Strong technical writing skills with the ability to produce clear, concise, and comprehensive validation documentation
Strong Technical Writing background
FMEA experience
Hands-on experience with ELISA (Enzyme-Linked Immunosorbent Assay) techniques and data interpretation
Familiarity with regulatory requirements such as FDA, ISO, and cGMP guidelines
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