Process Engineer II

Location: Riverview, Florida

About the role

A Validation Engineer is sought to support equipment and process validation activities within a regulated medical device manufacturing environment. This role will focus on the design, development, execution, and documentation of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols while ensuring compliance with FDA regulations, GMP requirements, and Quality Management System (QMS) standards.

Responsibilities

• Design, write, execute, and document IQ/OQ/PQ validation protocols for manufacturing equipment and processes.
• Support equipment qualification, commissioning, startup, and process implementation activities.
• Perform validation activities including preventive maintenance reviews, calibration verification, utility assessments, software verification, functional testing, and training verification.
• Ensure material, equipment, and data traceability throughout validation activities.
• Develop and maintain validation protocols, SOPs, test methods, equipment specifications, and change control documentation.
• Utilize statistical analysis tools, including Minitab and SPC methodologies, to support validation and process improvement efforts.
• Collaborate with manufacturing, quality, engineering, suppliers, and contractors to support project execution and compliance requirements.
• Ensure compliance with FDA regulations, GMP requirements, and internal quality standards.

Requirements

• Bachelor's degree in Engineering or a related technical discipline.
• 2+ years of engineering experience in a manufacturing environment.
• Hands-on experience within medical device manufacturing or another highly regulated industry.
• Experience designing, writing, and executing IQ/OQ/PQ validations.
• Knowledge of FDA regulations, GMP requirements, equipment qualification, and process validation methodologies.
• Experience authoring validation documentation and working within Quality Management Systems (QMS).
• Proficiency with Microsoft Office Suite.

Preferred Qualifications

• Experience with Minitab, SPC, and process capability studies.
• Experience supporting equipment commissioning and startup activities.
• Knowledge of supplier qualification and vendor management.
• Experience with printing or labeling systems.
• AutoCAD experience.

Benefits

• Medical, dental, vision, life, and disability insurance plans.
• Employee Stock Purchase Program (ESPP).
• 401K program with company match after 12 months of tenure.
• Health Savings Account (HSA) on the HDHP plan.
• SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions.
• Corporate discount savings program and other discounts.
• On-demand training program and access to certification prep, technical and leadership courses/books/seminars after 6+ months of tenure.
• Certification discounts and perks for associations including CompTIA and IIBA.
• Dedicated customer service team and certified Career Coach.