Katalyst CRO ยท 2 months ago
Validation Specialist (CQV)
Los Angeles, CA
Contract
Onsite
Mid Level
3+ years expKatalyst CRO is seeking a CQV Validation Specialist to perform commissioning, qualification, and validation of process equipment, utilities, and facilities for a regulated pharmaceutical manufacturing site. The role involves executing protocols, supporting cleaning validation, and collaborating with various departments to ensure compliance with GMP and FDA guidelines.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Execute and author IQ/OQ/PQ protocols for equipment, utilities, and facilities per the Validation Master Plan (VMP)
Perform temperature mapping for controlled areas, storage units, and process systems
Support cleaning validation develop MACO calculations, perform swab/rinse sampling, and review analytical results
Lead and review validation documentation including protocols, reports, and risk assessments
Collaborate with Engineering, QA, and Manufacturing during commissioning and qualification activities
Support change controls, deviations, and CAPA related to validated systems
Participate in validation reviews and contribute to continuous improvement of site validation practices
Qualification
Required
Bachelor's degree in engineering, Biotechnology, Life Sciences, or related field
36 years of CQV experience within pharmaceutical or biotech manufacturing
Strong understanding of GMP, FDA guidelines
Hands-on experience in equipment and cleaning validation, including utilities such as WFI, clean steam, and HVAC
Preferred
Proficiency in temperature mapping tools (e.g., Kaye Validator or equivalent) preferred
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO 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 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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