Process Engineer II

Job#: 3044741

Job Description:
Process Engineer II

Location: Riverview, Florida

Position Overview

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. The candidate will have hands-on experience designing, writing, and executing medical device validations and be able to speak in depth about their validation methodology and technical decisions.

Key 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.

Required Qualifications

• 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.

Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRateds Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.

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Everforth Apex Benefits Overview: Everforth Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Everforth Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Everforth Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Everforth Apex team member can provide.

Everforth Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Everforth Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.

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