Plastic Validation Engineer Medical Device (FDA-Focused, Including Cleaning Validation)

Overview We are seeking a highly skilled Plastic Validation Engineer to support validation activities for plastic components, injection molding processes, and cleaning systems within a regulated medical device manufacturing environment . This is a hands-on role working cross-functionally to ensure products meet stringent quality and regulatory standards. Key Responsibilities Lead and execute validation activities ( IQ/OQ/PQ ) for injection molding processes, tooling, and automated systems Develop and implement cleaning validation protocols (equipment, molds, contact surfaces) Define acceptance criteria for residues, bioburden, and contamination control Perform sampling methods (swab/rinse) and analyze validation data Support new product introduction (NPI) , process transfers, and change control Conduct risk assessments (FMEA) and process capability studies (Cp/Cpk) Troubleshoot molding defects and optimize process parameters Author and review validation documentation (protocols, reports, deviations, CAPAs) Required Qualifications Bachelor's degree in Engineering (Mechanical, Chemical, Plastics, or related) 3-7+ years of validation experience in medical device or regulated industry Strong expertise in injection molding and plastic materials Hands-on experience with cleaning validation and contamination control Knowledge of validation lifecycle (IQ/OQ/PQ) and statistical analysis Familiarity with U.S. Food and Drug Administration regulations (21 CFR Part 820), ISO ISO 13485, and Good Manufacturing Practice Preferred Experience with automated systems / CSV Background in Class II or Class III medical devices Exposure to environmental monitoring and sterilization processes Why Join Work with cutting-edge medical device technologies High-impact role with cross-functional visibility Opportunity to contribute to life-saving products Competitive compensation and growth potential Apply Now If you're a validation professional with strong plastics and FDA-regulated experience, we'd like to hear from you.

Pay:

$40.00

• $45.

00 per hour

Work Location:

In person Plastic Validation Engineer

• Medical Device (FDA-Focused, Including Cleaning Validation) 4.7 4.7 out of 5 stars Lancaster, MA 01523 $40
• $45 an hour
• Contract Qultek Consultants Inc. 3 reviews $40
• $45 an hour
• Contract Overview We are seeking a highly skilled Plastic Validation Engineer to support validation activities for plastic components, injection molding processes, and cleaning systems within a regulated medical device manufacturing environment .

This is a hands-on role working cross-functionally to ensure products meet stringent quality and regulatory standards. Key Responsibilities Lead and execute validation activities ( IQ/OQ/PQ ) for injection molding processes, tooling, and automated systems Develop and implement cleaning validation protocols (equipment, molds, contact surfaces) Define acceptance criteria for residues, bioburden, and contamination control Perform sampling methods (swab/rinse) and analyze validation data Support new product introduction (NPI) , process transfers, and change control Conduct risk assessments (FMEA) and process capability studies (Cp/Cpk) Troubleshoot molding defects and optimize process parameters Author and review validation documentation (protocols, reports, deviations, CAPAs) Required Qualifications Bachelor's degree in Engineering (Mechanical, Chemical, Plastics, or related) 3-7+ years of validation experience in medical device or regulated industry Strong expertise in injection molding and plastic materials Hands-on experience with cleaning validation and contamination control Knowledge of validation lifecycle (IQ/OQ/PQ) and statistical analysis Familiarity with U.S. Food and Drug Administration regulations (21 CFR Part 820), ISO ISO 13485, and Good Manufacturing Practice Preferred Experience with automated systems / CSV Background in Class II or Class III medical devices Exposure to environmental monitoring and sterilization processes Why Join Work with cutting-edge medical device technologies High-impact role with cross-functional visibility Opportunity to contribute to life-saving products Competitive compensation and growth potential Apply Now If you're a validation professional with strong plastics and FDA-regulated experience, we'd like to hear from you.

Pay:

$40.00

• $45.

00 per hour

Work Location:

In person