VALIDATION ENGINEER

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

Description

Join Plas-Tech Engineering!

Come join a vibrant and disruptive company that has been awarded \"Wisconsin's Manufacturer of the Year\"! Become an integral part of a diverse team at a leading medical manufacturing organization. By joining the PPL team, you will help make a difference in people's lives by supporting the company in its efforts to bring new medical technologies to the market.

Why Join Plas-Tech?

Plas-Tech Engineering is a growing medical manufacturer that makes its employees and customers their #1 priority. As our company continues to expand, we are looking to add motivated and enthusiastic individuals to our team. If you are searching for a company that is exponentially growing, centered around customers, and cares about its employees, PPL may be the right company for you!

Position Summary

PlasTech Engineering is seeking a hands-on Validation Engineer to lead the planning, authorship, execution, and lifecycle maintenance of equipment and process validations for injection-molded medical components and multi-component syringe assemblies. This role is accountable for the full validation lifecycle (IQ/OQ/PQ), mentors junior engineers, partners cross-functionally with Manufacturing, Quality, and Tooling, and drives statistically grounded continuous improvement on the shop floor within a GMP-regulated environment.

Key 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

Requirements

• 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; strong background in injection molding and automated assembly


• 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, capability analysis; 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

Key Competencies

• Analytical problem solving and structured root cause analysis


• Strategic, systems-level thinking with attention to detail


• Ownership, urgency, and prioritization in a dynamic manufacturing environment


• Influence without formal authority; collaborative team player

What We Offer

• High-impact role in a growing, mission-driven healthcare manufacturing environment


• Competitive compensation and comprehensive benefits


• Professional development and opportunities to expand validation and process excellence leadership