Katalyst CRO · 16 hours ago
Validation Engineer III
Athens, GA
Contract
Onsite
Senior Level
6+ years expKatalyst CRO is a company focused on compliance and quality in the manufacturing sector, and they are seeking a Validation Engineer III to ensure the validation of critical site equipment. The role involves drafting and executing validation plans, serving as a technical resource on project teams, and training personnel in quality principles.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Independently draft and execute complex validation plans, protocols, and test strategies to ensure compliance and expedited release of critical site equipment
Balance competing priorities while ensuring global work is conducted per regulatory requirements and company procedures
Serve on internal and external project teams (change controls, deviations, technology transfer) as a technical/compliance resource to solve quality-related issues and support continuous improvement
Train personnel in quality and validation principles
Support Engineering and other departments in the selection, review, acquisition, and upgrade of systems and production equipment
Provide technical support in developing user and functional requirements specifications (URS, RA, FRS, DQ) for systems and equipment
Act as Lead Validation representative on assigned project teams; communicate new requirements and perform training with Validation team to assure timelines are met for successful project completion and product launches
Share quality philosophies throughout Operations and support Production and Engineering
Perform all company business in accordance with regulations (EEO, FDA, etc.) and company policies
Develop audit responses and complete CAPAs by target due dates; ensure Validation areas are 'inspection ready at all times
Execute actions required to support Change Control, Deviation, and CAPA on-time closure
Qualification
Required
Minimum 6 years GMP validation or similar experience in a GMP manufacturing/production environment
Minimum 10 years GMP validation experience in a GMP or regulated manufacturing environment in lieu of a degree
At least 3 years leading projects
Ability to plan, schedule, organize, prioritize, and coordinate project activities
Ability to function in a leadership role and within cross-functional teams
Ability to analyze validation and production data to assess compliance with GMP requirements and troubleshoot compliance problems
Excellent written and verbal communication skills
Strong comprehension/application of FDA/EU/USDA regulatory requirements for production and distribution of regulated biological articles
Strong theoretical and practical knowledge of regulated processes and one technical discipline (e.g., biology)
Ability to make decisions regarding product acceptability based on documentation
Demonstrated ability to work with diverse groups and manage conflict
Proficiency in MS Word, Excel, Outlook, and PowerPoint
Bachelor's degree, preferably in a science or engineering-related field
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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