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Manufacturing Process Specialist

2 months ago

Riverview, Florida, United States Planet Pharma Full time

Position Overview:

The Manufacturing Process Specialist, reporting to the manufacturing engineering supervisor, will be instrumental in the execution of new product initiatives and process enhancements. Responsibilities include a variety of documentation and qualification tasks such as feasibility assessments, validation protocols, updates to standard operating procedures, training materials, and raw material specifications. This role will oversee the project timeline and engage in project management activities, collaborating with suppliers and managing external responsibilities.

Key Responsibilities:

  • Design and optimize processes and equipment to enhance productivity.
  • Implement process control measures through validation plans, data analysis, and statistical process control methodologies.
  • Demonstrate strong documentation and communication skills to effectively manage projects, vendors, test plans, and present actionable reports.
  • Exhibit organizational skills to prioritize tasks, including unplanned troubleshooting activities.
  • Ensure a clean and safe working environment for oneself and colleagues.
  • Show a sense of urgency, sound judgment, and pride in workmanship.
  • Display self-motivation and the ability to work independently as well as collaboratively within a team.
  • Utilize effective communication to keep supervisors informed about task status and job-related issues.

Qualifications:

  • Bachelor's degree in Mechanical or Electrical Engineering.
  • A minimum of 2 years of experience, preferably within the medical manufacturing sector.
  • Familiarity with IQ/OQ/PQ processes.
  • Knowledge of FDA regulations pertaining to medical device manufacturing and Good Manufacturing Practices (GMP).
  • Strong technical knowledge of manufacturing equipment and processes.
  • Experience in project management.

Preferred Skills:

  • Proficiency in Microsoft Office Suite, Agile, Minitab, or similar quality management/statistical analysis software.