VALIDATION ENGINEER in Lake Geneva, Wisconsin at Plas-Tech Engineering LLC

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

· 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