Manufacturing Process Specialist

2 weeks ago

Riverview, Florida, United States Apex Systems Full time

Apex Systems is looking for a Manufacturing Process Specialist to collaborate with our client, a prominent player in the medical device sector. This role requires onsite presence and involves a contract position with opportunities for extension or conversion.
Key Responsibilities: The Manufacturing Process Specialist will operate under the guidance of the manufacturing engineering supervisor, focusing on the execution of new product development and process integration. The responsibilities encompass a variety of documentation and qualification tasks, including but not limited to: feasibility assessments, validation documentation, modifications to standard operating procedures, training resources, updates to raw material specifications, and more. This position will oversee the project timeline and engage in project management duties. The specialist will liaise with suppliers and manage external engagements. Responsibilities also include designing and refining processes and equipment to enhance productivity, implementing process control measures through validation strategies, data analysis, and statistical process control methodologies. Strong documentation and communication skills are essential for managing projects, vendors, test plans, and presenting actionable reports.

Essential Functions:

  • Comprehension of FDA regulations related to medical device manufacturing, Good Manufacturing Practices (GMP), and process validations.
  • Experience with change documentation packages.
  • Conduct statistical analyses and feasibility studies for new processes.
  • Ability to draft clear and concise test protocols and procedures.
  • Proficient written and verbal communication skills.
  • Self-motivated and results-oriented individual.
  • Experience in a manufacturing environment with automated machinery; pharmaceutical experience is advantageous.
  • Familiarity with modern software applications, including project management tools.
  • Strong computer proficiency, particularly with MS Office Suite (Excel, Word, Project, etc.).
  • Ability to articulate ideas effectively in both written and spoken formats.
  • Capability to coordinate with diverse teams to achieve project objectives.
  • Experience working with contractors to assist in equipment process commissioning.
  • Excellent interpersonal and analytical skills.
  • Knowledge of design engineering tools such as AutoCAD and standard machine shop processes.
  • Adherence to certified standards, GMP, OSHA, and plant policies.
  • Exemplary work ethic, integrity, and punctuality.
  • Positive attitude and adaptability in a fast-paced environment.
Qualifications:
  • Bachelor's degree in Mechanical or Electrical Engineering.
  • A minimum of two years of experience, preferably in the medical manufacturing field.
  • Understanding of FDA regulations and GMP related to medical devices.
  • Strong technical knowledge of manufacturing equipment and processes.
  • Experience in project management.
  • Proficiency in manufacturing equipment validation and documentation.
Preferred Qualifications:
  • Experience with printing systems and labeling management systems.
  • Familiarity with Microsoft Office Software, Agile, Minitab, or equivalent QMS/statistical analysis software.
Work 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 welcome applicants from all backgrounds and do not discriminate based on any protected characteristic. Our company values innovation, collaboration, and continuous learning, offering comprehensive career resources, training, and benefits to our employees.

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