Manufacturing Process Validation Engineer

Medical devices manufacturing process validation, 21CFR Part 820, ISO 13485, process validation, mold validation, SAP, process improvements, Good Manufacturing Practices (GMP). Job Responsibilities: Assist in coordinating and supporting suppliers for manufacturing of custom equipment/tooling. Assist in coordinating purchase and delivery of equipment/tooling. Assist in coordinating installation of equipment/tooling. Support developing and executing IQ and OQ protocols and reports. Support developing and executing test method validations / Gage R&R. Support generating and issuing SOPs and manufacturing procedures for approval. Support developing and executing component qualifications. Support developing and executing PQ and PPQ protocols and reports. Support developing manufacturing capacity analysis. Support developing and executing process characterizations / Design of Experiments (DOE). Support developing documentation/justification for capital projects. Ensure compliance with cGMPs, quality standards, policies, and procedures. Perform other duties as assigned by the Process Validation Lead and supervisors. Qualifications: Knowledge and Skills: Bachelor's degree in engineering. Experience in the medical device industry, specifically in manufacturing process validation. Excellent written and verbal communication skills in English and Spanish. Experience with qualification/validation (IQ/OQ/PQ). Experience with test method validation and Gage R&R. Knowledge of process characterization and Design of Experiments (DOE). Experience in manufacturing line design and capacity analysis. Design experience with equipment and tooling. Experience in equipment installation and preventive maintenance procedures. Ability to perform root cause analysis and investigations. Experience in SOP and manufacturing procedure generation and change control. Understanding of product financials and supply chain design. Familiarity with OEE integration, vertical startup, and zero-loss mindset. Required Education and Experience: Bachelor's degree in engineering or related field with at least 3 years of engineering experience, or a master's degree with at least 2 years of engineering experience. #J-18808-Ljbffr TechDigital Group