Manufacturing Process Validation Engineer

Medical devices manufacturing process validation, 21

CFR 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.

• 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.

• 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.