Katalyst CRO ยท 2 months ago
Validation Engineer II
Vacaville, CA
Contract
Onsite
Entry, Mid Level
2+ years expKatalyst CRO is a biopharmaceutical company seeking a Validation Engineer II to support QC laboratory equipment qualification activities. The role focuses on ensuring compliance with cGMP, corporate quality standards, and regulatory expectations while contributing to patient safety and operational excellence.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Perform equipment qualification per EQ policies and procedures
Partner with QC lab staff to define qualification requirements
Author, review & execute qualification protocols
Coordinate with vendors and cross-functional support teams
Identify quality, compliance, and operational gaps
Review/sign-controlled documentation per Genentech guidelines
Support QC operations with additional assignments
Qualification
Required
Pharma or biopharma experience required
Knowledge of cGMP regulations
Ability to manage schedules, shifting priorities, and deadlines
Strong verbal & written communication
Ability to influence and build relationships
Strategic and execution-focused mindset
High accountability and ownership of deliverables
Preferred
BS/BA in a relevant scientific discipline (preferred)
2+ years in validation or equipment qualification (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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