Process Engineer

Apex Systems is seeking a Process Engineer to join our esteemed healthcare client located in Riverview, FL.

Job Title: Process Engineer

Location: Riverview, FL

Start Date: July 2025

Compensation: $30/hr

Schedule: Monday-Friday, normal business hours

Benefits: Health, dental, vision, 401k, and weekly pay structure

Duties:

• Implement new product development and process implementations.
• Conduct documentation/qualification activities including feasibility studies, validation protocols, SOP changes, training material, drawings, and raw material specifications updates.
• Manage the site timeline for the project and participate in project management activities.
• Engage with suppliers and manage all external responsibilities.
• Design and develop processes and equipment to improve productivity.
• Provide process control measures through validation plans, data analysis, and statistical process control techniques.
• Manage projects, vendors, test plans, and present cost-justifiable action plans and reports.
• Maintain a clean and safe work environment.
• Display a sense of urgency, sound judgment, and pride in workmanship.
• Work independently and as part of a team.
• Utilize upward communication to keep the supervisor informed of task status, job-related problems, and other work-related information.

Skills and Competencies:

• Understanding of FDA regulations surrounding the manufacture of medical devices, GMPs, and process validations.
• Experience with change documentation packages.
• Statistical analysis and feasibility studies for new processes.
• Ability to write clear and concise test protocols and procedures.
• Good written and verbal communication skills.
• Self-driven and result-oriented.
• Experience with manufacturing environments and automated machines.
• Pharmaceutical experience is a plus.
• Knowledge of modern computer programs, including project management software.
• Strong computer skills and proficiency in MS Office Suite (Excel, Word, Project, etc.).
• Ability to express ideas both in written and oral communications.
• Ability to coordinate with different people to accomplish tasks.
• Ability to assist contractors with equipment process commissioning.
• Excellent interpersonal and reasoning skills.
• Knowledge of design engineering tools such as AutoCAD, standard machine shop processes, and specialty shop capabilities.
• Follow all certified standards, GMP, OSHA, plant policies, and procedures.
• Sets the standard for timeliness, work ethic, and personal integrity.
• Positive attitude and result-oriented.
• Ability to manage multiple tasks in a high-paced environment and adapt to scope changes.

Preferred Skills/Qualifications:

• Experience using Microsoft Office Software, Agile, Minitab, or equivalent QMS/statistical analysis software.

Education:

• B.S. in Mechanical, Electrical Engineering, or closely related degree required.

Experience:

• Minimum 2 years of experience, preferably in a medical manufacturing industry.
• Understanding of FDA regulations surrounding the manufacture of medical devices and GMPs.
• Strong technical expertise in manufacturing equipment and processes.
• Project management experience.
• Manufacturing equipment validation and documentation updates.
• Preferred: Experience with printing systems and labeling management systems.

EEO Employer:

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. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystems.com or 844-463-6178.