Apex Systems

Job#: 2080347

Job Description:

Apex is looking for a Process Engineer to work onsite in Riverview, FL starting in July!

Duties:

• Employee will work with the implementation of new product development and process implementations. The documentation/qualification activities include but not limited to: feasibility studies, validation protocols, standard operating procedures changes, training material, drawings, raw material specifications updates etc. This resource will manage the site timeline for the project and will participate in the project management activities. This contractor will 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. Documentation and communication skills to manage projects, vendors, test plans, and present cost-justifiable action plans and reports. Organizational skills to manage/prioritize task assignments, amongst unplanned troubleshooting tasks.
• Maintain a clean and safe work environment for self and others. Display a sense of urgency, sound judgment, and pride in workmanship. Display self-motivation and the ability to work independently and as part of a team. Utilize upward communication to keep supervisor informed of task status, job-related problems, and other information related to work activity.

Skills And Competencies:

• Understanding of FDA regulations surrounding the manufacture of medical devices, GMPs, and process validations.
• Experience with change documentation package.
• Statistical analysis and feasibility studies for new process
• Ability to write clear and concise Test Protocols and Procedures
• Good written and verbal skills
• Self driven individual and result-oriented person
• Experience with manufacturing environment and automated machines.
• Pharmaceutical experience is considered a plus.
• Knowledge of modern computer programs to include project management software.
• Strong Computer skills & MS office suite (Excel, Word, Project etc.)
• Ability to express ideas both in written and oral communications.
• Ability to coordinate with different people who have different priorities and agendas to accomplish the task at hand.
• Ability to deal with contractors in order to assist them with the 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, result-oriented person.
• Ability to manage multiple task in a high paced environment and willing to adapt and address scope changes.

Preferred Skills/Qualifications:

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

Education:

• Education required/ preferred: B.S. Mechanical or Electrical Engineering

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 on manufacturing equipment and process
• Project management experience
• Manufacturing equipment validation, Documentation updates &
• Preferred: Experience with printing systems and labeling management systems

Hours Per Week: 40.00

Hours Per Day: 8.00

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.

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join 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 ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.

Apex Benefits Overview: 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. 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, 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. 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 Apex team member can provide.