What are the responsibilities and job description for the Validation Engineer - Injection Molding position at Stark Pharma Solutions Inc?
Validation Engineer – Injection Molding
Own the Validation Behind Every Part That Ships
If a molded part fails downstream, it traces back to validation — and that's exactly where you'd sit in this role. We're looking for a hands-on Validation Engineer who knows plastic injection molding inside and out, ready to lead equipment, process, and manufacturing validations in a regulated environment where the work you sign off on actually matters.
You'll be the technical bridge between Manufacturing Engineering, Quality, Operations, and Automation — driving IQ/OQ/PQ protocols from first draft to final approval, and making sure new and existing molding processes hold up to real quality and regulatory scrutiny.
What You'll Own
- Build, run, and approve IQ/OQ/PQ protocols for injection molding equipment, automation, and manufacturing processes
- Lead validation for new product introductions, equipment installs, process transfers, and manufacturing changes
- Validate the full molding process — process windows, machine qualification, tooling, auxiliary equipment, and automation systems
- Run risk assessments using FMEA and other structured risk tools
- Dig into validation failures, process deviations, and nonconformances, then drive corrective actions that actually stick
- Turn process capability and statistical data into decisions that make manufacturing more robust
- Partner with Manufacturing Engineering to dial in molding parameters, cycle times, and overall process performance
- Support mold qualifications, process characterization, and production readiness
- Own the paper trail — validation reports, technical documentation, protocols, and supporting engineering records
- Participate in FAT/SAT activities when equipment calls for it
- Keep validation documentation aligned with FDA, ISO 13485, GMP, and internal quality standards
- Support CAPA investigations, change control, and regulatory audits
- Work cross-functionally across Engineering, Quality, Production, Tooling, Automation, and Regulatory Affairs
What You Bring
- Bachelor's degree in Engineering or a related technical field
- 3 years of validation engineering experience in a manufacturing environment
- Hands-on experience validating plastic injection molding processes and equipment
- Solid grasp of IQ/OQ/PQ methodology and validation lifecycle documentation
- Experience with process validation, equipment qualification, and process development
- Familiarity with scientific molding principles and process optimization
- Comfort with statistical analysis tools and process capability studies
- Working knowledge of PFMEA/FMEA risk methodologies
- Strong technical writing and documentation skills
Nice to Have
- Medical device, pharmaceutical, or other highly regulated manufacturing experience
- Experience with automated equipment, robotics, vision systems, or PLC-controlled systems
- Knowledge of FDA 21 CFR Part 820, ISO 13485, GMP, and GAMP guidance
- Injection mold qualification, tooling validation, or mold transfer experience
- Cleanroom manufacturing exposure
- CAPA, NCR investigation, or change control experience
- Working knowledge of Minitab or similar statistical software
Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.