Katalyst CRO · 2 months ago
Validation Engineer II
Vacaville, CA
Contract
Onsite
Entry, Mid Level
2+ years expKatalyst CRO is a company focused on laboratory operations, and they are seeking a Validation Engineer II to ensure the qualification of laboratory equipment. The role involves coordinating with laboratory personnel, authoring protocols, and identifying compliance gaps to support quality control operations.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Perform qualification of laboratory equipment in accordance with EQ policies, plans and procedures
Coordinate with laboratory personnel to define qualification requirements
Author, review and execute equipment qualification protocols
Coordinate equipment qualification activities with vendors and other support groups
Identify business, quality, and compliance gaps
Sign documents for activities as authorized and described by client's policies, procedures and job descriptions
Perform any other tasks as requested by Senior Management to support QC laboratory operations
Qualification
Required
BS/BA degree (preferably in relevant scientific discipline)
Experience (may vary depending on site size/scope)
Experience in the pharmaceutical, biopharmaceutical industry or an equivalent combination of education and experience
Knowledge of cGMP or equivalent regulations
Minimum of two year's experience in Validation or equipment qualification is desired
Ability to make sound decisions about scheduling and managing of priorities
Flexibility in problem solving, providing direction and work hours to meet business objectives
Possesses strong verbal and written communication skills and the ability to influence at all levels
Capable of building trustful and effective relationships
Able to think strategically and translate strategies into actionable plans
Takes responsibility, drives results, and achieves expected outcomes
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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