Katalyst CRO ยท 3 hours ago
Validation Specialist IV
Portsmouth, NH
Contract
Onsite
Mid Level
4+ years expKatalyst CRO is seeking a Validation Specialist IV to ensure all critical GMP equipment and systems are validated and maintained in compliance with user requirements and global regulatory guidelines. The role involves performing equipment validation activities and providing support for quality systems to ensure a compliant manufacturing environment.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Perform Equipment Validation activities to include Validation Maintenance Quality Systems review and requalification to ensure GMP equipment is continuously maintained in a validated state
Program, organize, and maintain Validation equipment and supplies including dataloggers and probes
Demonstrate a general understanding of biopharmaceutical manufacturing equipment and validation procedures for Installation Verification (IV/IQ), Steam-In-Place (SIP), Autoclaves, Clean Utilities, Shipping Validation, Temperature Mapping Controlled Storage Rooms, and Equipment
Develop validation protocols from plans and engineering documents
Provide basic technical support when reviewing and approving SOPs, Protocols, Change Controls, Deviations, CAPA, etc
Perform assigned Quality Systems activities within Document Management System (DMS), Laboratory Information Management System (LIMS), and TrackWise Quality System (Change Control, Deviation, CAPA)
Perform other duties as assigned
Qualification
Required
Equipment Validation Specialist exists to ensure all critical GMP equipment and systems are validated and maintained in compliance with user requirements, process parameters and global regulatory guidelines
The role provides Operations, Quality Assurance, and regulatory bodies with scientifically sound, documented evidence that systems and processes will perform as required so they can be assured of a quality, compliant manufacturing environment
Perform Equipment Validation activities to include Validation Maintenance Quality Systems review and requalification to ensure GMP equipment is continuously maintained in a validated state
Program, organize, and maintain Validation equipment and supplies including dataloggers and probes
Demonstrate a general understanding of biopharmaceutical manufacturing equipment and validation procedures for Installation Verification (IV/IQ), Steam-In-Place (SIP), Autoclaves, Clean Utilities, Shipping Validation, Temperature Mapping Controlled Storage Rooms, and Equipment
Develop validation protocols from plans and engineering documents
Provide basic technical support when reviewing and approving SOPs, Protocols, Change Controls, Deviations, CAPA, etc
Perform assigned Quality Systems activities within Document Management System (DMS), Laboratory Information Management System (LIMS), and TrackWise Quality System (Change Control, Deviation, CAPA)
Perform other duties as assigned
4 years' experience in Mfg
Preferred
4-year degree strongly 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 (28)
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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