Katalyst CRO ยท 2 weeks ago
Process Validation Engineer
Warsaw, IN
Contract
Onsite
Mid Level
4+ years expKatalyst CRO is a company that supports medical device manufacturing, and they are seeking a Process Validation Engineer to develop, execute, and maintain validated manufacturing and test processes. The role ensures compliance with FDA QSR, ISO 13485, and cGMP requirements while collaborating cross-functionally to improve process capability, quality, and efficiency.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Develop and execute process validation strategies, including process characterization and creation of IQ, OQ, and PQ protocols and reports
Perform equipment IQ/OQ, process OQ/PQ, test method validation, and Gage R&R studies
Ensure regulatory compliance with FDA QSR, ISO 13485, and internal quality system requirements; participate in audits as needed
Compile, analyze, and interpret validation and SPC data; identify trends and opportunities for continuous improvement
Lead root cause analysis and problem-solving activities for technical and process-related issues using quality and statistical tools
Support and lead change management activities including Change Management System, Nonconformance Reports, CAPA, Engineering Specifications, and Work Instructions
Create, maintain, and improve controlled technical documentation such as prints, procedures, bills of materials (BOM), and routers
Establish, evaluate, and improve manufacturing process methods that meet performance, quality, and CTQ requirements
Conduct feasibility studies to estimate product cost and analyze capital equipment, capacity, and capability requirements
Support a wide variety of manufacturing processes including machining, finishing, forging, casting, cleaning, heat treating, bonding, and molding
Collaborate cross-functionally with Manufacturing, Quality Assurance, Engineering, and other teams to resolve issues, implement strategies, and provide technical support
Develop and execute project plans and schedules; prioritize multiple medium-complexity projects and communicate progress effectively
Communicate project plans and technical direction clearly through written and verbal communication with cross-functional teams
Read and interpret engineering drawings and specifications to support manufacturing and validation activities
Qualification
Required
46 years of experience supporting medical device manufacturing process validations
Working knowledge of design control, FDA QSR (21 CFR 820), ISO 13485:2003, and cGMP requirements
Proficiency in statistical tools including SPC, PFMEA, CTQ analysis, and general statistics
Experience with Microsoft Office Suite and Microsoft Project
Strong written and verbal communication skills with the ability to work effectively in cross-functional teams
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
Company data provided by crunchbase