Lead Validation Engineer – Medical Devices & GMP

Plas-Tech Engineering LLC; Lake Geneva (WI); On-site; USD 90,000 - 150,000; Full time

Benefits offered by this job

Competitive compensation

Comprehensive benefits

Professional development

Job summary

Plas-Tech Engineering is seeking a hands-on Validation Engineer to lead IQ/OQ/PQ activities for injection-molded medical components and syringe assemblies, within a GMP environment.

You will mentor junior engineers, collaborate with Manufacturing, Quality, and Tooling, and drive data-driven improvements while upholding Part 11 and QMS standards. Competitive compensation and benefits are offered, with opportunities for advancement.

Qualifications

• Bachelor's degree in Engineering (Mechanical, Manufacturing, Industrial, Biomedical, or related); advanced degree a plus.
• 6+ years of validation experience in medical device, pharma, or combination products.
• Deep knowledge of cGMP, ISO 13485, 21 CFR 820 and Part 11; familiarity with GAMP 5 and risk-based validation approaches.
• Proven track record authoring and executing IQ/OQ/PQ, including sampling strategies, test method validation, and clear acceptance criteria.
• Strong statistics proficiency: DOE, MSA (gage R&R), SPC; experience with Minitab or similar tools.
• Demonstrated leadership on the shop floor and in cross-functional settings; excellent communication and stakeholder management.
• Exceptional technical writing, documentation rigor, and GDP/data integrity discipline.
• Experience with mold/process qualifications (e.g., scientific molding/RJG), cleanroom manufacturing, and regulated change control.

Responsibilities

• Own the site validation strategy and roadmap for injection molding, assembly, and supporting equipment in alignment with cGMP and ISO 13485.
• Author and approve validation deliverables: Validation Plans, URS, risk assessments (PFMEA), IQ/OQ/PQ protocols and reports, and periodic reviews to maintain the validated state.
• Lead shop-floor execution of protocols; coordinate cross-functional resources, sampling, instrumentation, and test method adherence; ensure safety and compliance.
• Establish and confirm critical process parameters, control limits, and process capability (Cp/Cpk) using DOE, MSA, and SPC; translate findings into robust process controls.
• Analyze manufacturing and validation data to identify trends; drive structured root cause analysis, CAPA, and sustainable process improvements with clear ROI.
• Provide technical leadership for mold qualifications, material changes, equipment transfers, and engineering changes ensuring validated state and documentation integrity.
• Strengthen the Quality Management System (QMS) by improving templates, work instructions, and workflows; support internal/external audits and customer visits.
• Champion data integrity and Part 11 principles in computerized systems; collaborate with IT/QA for system validation and audit trails where applicable.
• Coach and mentor engineers/technicians on validation best practices, scientific molding concepts (e.g., RJG), GDP, and statistical thinking.

Skills

Validation

GMP ISO13485

IQ/OQ/PQ

DOE

MSA

SPC

Cross-functional

Leadership

Education

Bachelor's degree in Engineering

Advanced degree a plus

Tools

Minitab

RJG

Job description

Plas-Tech Engineering is seeking a hands-on Validation Engineer to lead IQ/OQ/PQ activities for injection-molded medical components and syringe assemblies, within a GMP environment.

You will mentor junior engineers, collaborate with Manufacturing, Quality, and Tooling, and drive data-driven improvements while upholding Part 11 and QMS standards. Competitive compensation and benefits are offered, with opportunities for advancement.