Process Validation Engineer

Company : Karwell Technologies

Job Description:

• The Process Validation Engineer supports medical device manufacturing by developing, executing, and maintaining validated manufacturing and test processes.
• The role ensures compliance with FDA QSR (21 CFR 820), ISO 13485, and cGMP requirements while collaborating cross-functionally to improve process capability, quality, and efficiency across a variety of manufacturing operations.

Roles & 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.

Education & Experience:

• 4 6 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.

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