Katalyst CRO ยท 1 day ago
Validation Engineer
Jersey City, NJ
Contract
Onsite
Entry, Mid Level
2+ years expKatalyst CRO is a company focused on providing contract research organization services, and they are seeking a Validation Engineer to ensure compliance with FDA regulations and support manufacturing processes. The role involves writing validation protocols, collaborating with multi-functional teams, and maintaining effective communication across various levels of the organization.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Writing and execution of validation protocols and reports (ie. IQ, OQ, PQ, etc.)
Developing and implementing manufacturing processes, preparation of specifications and operator instructions, process studies, production readiness, investigations, root cause analysis, problem solving and report or presentation preparation
Updating procedures, manufacturing specifications, bills, routes and travelers for product & process changes in the PLM system
Working with OEM equipment manufacturers and distributors to develop user requirements
Work on new asset commissioning
Working with multi-functional teams (Operations Value Stream, OpEx, Planning, Engineering, and Quality) to align on validation strategy, author validation documents, coordinate execution and document approvals
Ensuring compliance with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments when supporting projects
Maintains positive and cooperative communication and collaboration with all levels of employees, customers, contractors, and vendors
Qualification
Required
Writing and execution of validation protocols and reports (ie. IQ, OQ, PQ, etc.)
Developing and implementing manufacturing processes, preparation of specifications and operator instructions, process studies, production readiness, investigations, root cause analysis, problem solving and report or presentation preparation
Updating procedures, manufacturing specifications, bills, routes and travelers for product & process changes in the PLM system
Working with OEM equipment manufacturers and distributors to develop user requirements
Work on new asset commissioning
Working with multi-functional teams (Operations Value Stream, OpEx, Planning, Engineering, and Quality) to align on validation strategy, author validation documents, coordinate execution and document approvals
Ensuring compliance with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments when supporting projects
Maintains positive and cooperative communication and collaboration with all levels of employees, customers, contractors, and vendors
2-4 years of experience in manufacturing and/or process engineering
Strong technical writing skills, with appropriate awareness of intended audience
Ability to effectively communicate across multiple audiences, including operators, peers and management, in both written and oral manners
Process validation experience
Experience in a Medical Device and/or regulated manufacturing work environment
Persuasive communication and interpersonal skills
Digital literacy, including use of Microsoft Office tools
Experience working in a regulated industry, such as Medical Device
Experience with machining processes, metal finishing processes, laser processing or production automation
Hands-on experience with machining processes, casting, metal finishing processes, laser processing or production automation
Knowledge of statistical data analysis and associated tools (e.g. Minitab)
Basic knowledge of Geometric Dimensioning and Tolerancing (GD&T)
Willingness to support global projects, which may include travel
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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