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Engineering Process Consultant

2 months ago

Riverview, Florida, United States Apex Systems Full time

Apex Systems is looking for a Manufacturing Process Specialist to support our client, a prominent entity in the medical device sector. This position requires onsite engagement and involves a contract role with opportunities for extension or conversion.
Key Responsibilities: The Manufacturing Process Specialist will collaborate with the manufacturing engineering supervisor to facilitate the rollout of new product initiatives and process enhancements. Responsibilities include but are not limited to: conducting feasibility assessments, creating validation documentation, revising standard operating procedures, developing training materials, and updating raw material specifications. This role will oversee project timelines and engage in project management activities, liaising with suppliers and managing external responsibilities. The specialist will design and refine processes and equipment to enhance productivity, ensuring process control through validation plans, data analysis, and statistical process control methodologies. Strong documentation and communication skills are essential for managing projects, vendors, test plans, and presenting actionable reports. Organizational abilities are crucial for prioritizing tasks, especially in unplanned troubleshooting scenarios. Maintaining a clean and safe work environment is imperative, alongside demonstrating urgency, sound judgment, and pride in workmanship. The ideal candidate will exhibit self-motivation and the capability to work independently as well as collaboratively within a team.

Essential Functions:

  • Comprehension of FDA regulations relevant to medical device manufacturing, GMPs, and process validations.
  • Experience with change documentation packages.
  • Conducting statistical analyses and feasibility studies for new processes.
  • Ability to draft clear and concise test protocols and procedures.
  • Strong written and verbal communication skills.
  • Self-driven and results-oriented individual.
  • Experience in a manufacturing environment, particularly with automated machinery; pharmaceutical experience is advantageous.
  • Proficiency in modern computer applications, including project management software.
  • Strong computer skills, particularly with the MS Office suite (Excel, Word, Project, etc.).
  • Ability to articulate ideas effectively in both written and oral formats.
  • Capability to coordinate with diverse stakeholders to achieve project objectives.
  • Experience in collaborating with contractors for equipment process commissioning.
  • Excellent interpersonal and analytical skills.
  • Familiarity with design engineering tools such as AutoCAD and standard machine shop processes.
  • Adherence to certified standards, GMP, OSHA, and plant policies.
  • Setting benchmarks for timeliness, work ethic, and integrity.
  • Positive attitude and a results-driven mindset.
  • Adept at managing multiple tasks in a fast-paced environment and willing to adapt to scope changes.
Requirements:
  • Bachelor's degree in Mechanical or Electrical Engineering.
  • A minimum of 2 years of experience, preferably in the medical manufacturing field.
  • Understanding of FDA regulations related to medical device manufacturing and GMPs.
  • Strong technical knowledge of manufacturing equipment and processes.
  • Experience in project management.
  • Familiarity with manufacturing equipment validation, documentation, and updates.
Preferred Qualifications:
  • Experience with printing systems and labeling management systems.
  • Proficiency in Microsoft Office Software, Agile, Minitab, or equivalent QMS/statistical analysis software.
Schedule: 40 hours per week, 8 hours per day.

Apex Systems is an equal opportunity employer, committed to diversity and inclusion in the workplace. We do not discriminate based on race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, or any other characteristic protected by law. We welcome qualified applicants with criminal histories in a manner consistent with applicable law. Apex Systems values innovation, collaboration, and continuous learning, offering quality career resources, training, certifications, and a comprehensive benefits package.