Katalyst CRO · 20 hours ago
Packaging Validation Engineer
Bloomington, IN
Contract
Onsite
Mid, Senior Level
4+ years expKatalyst CRO is a company focused on providing contract research services, and they are seeking a Packaging Validation Engineer to ensure compliance with regulatory requirements. The role involves preparing verification protocols, leading complaint investigations, and collaborating with various teams to meet packaging validation standards.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Support engineering in product validation, risk assessments, product/process development, and change management
Support and lead continuous improvement activities through leadership, facilitation, and collaboration
Ensure all packaging validation activities are properly documented and controlled
Collaborate with QA, Engineering, Manufacturing, and Regulatory teams to ensure packaging meets product and compliance requirements
Communicate effectively across departments regarding packaging validation status and issues
Qualification
Required
Prepare packaging verification protocols and reports in compliance with regulatory and internal requirements
Hands-on experience in Process validation (IQ, OQ & PQ) activities
Lead or support complaint investigations and resolution related to packaging
Support engineering in product validation, risk assessments, product/process development, and change management
Support and lead continuous improvement activities through leadership, facilitation, and collaboration
Ensure all packaging validation activities are properly documented and controlled
Collaborate with QA, Engineering, Manufacturing, and Regulatory teams to ensure packaging meets product and compliance requirements
Communicate effectively across departments regarding packaging validation status and issues
Good documentation practice skills
Good verbal and oral communication skills
Good Knowledge in ISO 13485, ISO 14971, FDA 21 CFR 820
Hands on experience in Engineering change order creation in Agile
Recent 4-6 years' experience in Packaging Validation activities
Hands on experience in packaging validation activities, including packaging integrity, shelf life, and transit testing
Mandatory: Medical Device Industry
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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