Katalyst CRO ยท 2 months ago
Packaging Validation Engineer
Greenville, SC
Contract
Onsite
Senior LevelKatalyst Healthcares & Life Sciences is seeking a Packaging Validation Engineer to lead packaging validation projects and ensure compliance with regulatory requirements. The role involves developing validation documentation, managing cross-functional communication, and providing hands-on support during commissioning phases.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Lead the packaging validation project, coordinating cross-functional efforts and ensuring alignment with project objectives, timelines, and regulatory requirements
Develop and execute validation documentation (URS, risk assessments, FAT/SAT, IQ/OQ/PQ, and final reports) for packaging lines and related equipment, including fillers, cappers, labellers, conveyors, vision inspection, and serialization systems
Manage communication between validation, engineering, and quality teams to drive efficient decision-making and issue resolution
Oversee qualification of change parts, line configuration changes, and multiple bottle/cap presentations
Provide hands-on support during commissioning and execution phases, including troubleshooting and deviation resolution
Support process performance qualification (PPQ) activities and readiness for commercial production
Ensure all validation deliverables comply with cGMP, FDA, and EU Annex 1 requirements, as well as internal procedures and the site's Validation Master Plan (VMP)
Qualification
Required
Bachelor's degree in engineering or Natural Sciences
Experience in packaging validation for sterile or aseptic liquid operations
Demonstrated experience leading validation projects or small technical teams
Solid understanding of liquid filling systems, packaging automation, inspection technologies, and capping mechanisms
Strong knowledge of GAMP 5, 21 CFR Part 11, and Annex 1
Excellent communication, organization, and documentation skills, with the ability to effectively interact with clients, peers, and management
Ability to work independently and manage multiple priorities in a fast-paced, regulated environment
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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