Katalyst CRO ยท 2 hours ago
Equipment Validation Engineer
Wilson, NC
Contract
Onsite
Senior Level
5+ years expKatalyst CRO is seeking an Equipment Validation Engineer responsible for the implementation and coordination of equipment and facilities validation programs in compliance with cGMPs and FDA requirements. The role involves developing and executing validation protocols, ensuring the accuracy and compliance of validation studies, and leading qualification processes throughout the project lifecycle.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Participate in the commissioning, qualification and start-up of various pharmaceutical cGMP process and packaging equipment, utilities & facilities
Coordinate, develop and prepare installation, operation and performance qualification protocols for production equipment and production related facilities validation. Including the validation of manufacturing and packaging equipment, HVAC, Compressed Air and Purified Water systems
Coordinate and perform the execution of validation studies. Prepare validation reports, including data analysis, conclusions, and recommendations
Lead the development (for example, write test cases) of key qualification deliverables such as DQ, FAT, SAT, IQ, OQ and PQ during the project lifecycle
Able to perform field execution of qualification test cases and protocols
Lead qualification processes throughout the project lifecycle to ensure timely completion and to ensure all quality and engineering specifications are met
Possess knowledge of relevant regulatory requirements and industry best practices on all or any of the following Process equipment, clean utilities, automation systems, laboratory equipment, building & facilities
Perform other related assignments and duties as required and assigned
Qualification
Required
Bachelor's degree in engineering, a Scientific discipline, or a degree in some other discipline
5+ years of experience in commissioning, qualification, validation of various systems within the pharmaceutical/biotech industry
Knowledge of cGMPs and FDA guidelines and regulations acquired through education, experience and training
Experience with commissioning & qualification of equipment & facilities is required
Ability to handle multiple projects and work in a fast-paced environment
Strong multi-tasking skills
Effective written and oral communication skills
High proficiency in preparing documents with MS Word and editing Access Data Bases
Preferred
Validation experience such as cleaning validation, thermal validation, mixing studies, process validation, computer systems validation is an asset but not required
Experience with commissioning & qualification of process control systems (i.e. PCS, SCADA, Historians) and building automation systems are considered an asset
Experience with preparation and execution of URS's, DQ's, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs
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
Company data provided by crunchbase