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Engineering Process Consultant

2 months ago

Riverview, Florida, United States Planet Pharma Full time

Position Overview:

The Manufacturing Process Specialist, under the guidance of the engineering supervisor, will contribute to the execution of new product initiatives and process enhancements. The responsibilities encompass a variety of documentation and qualification tasks, including but not limited to: feasibility assessments, validation documentation, updates to standard operating procedures, training resources, design specifications, and raw material guidelines.

This role will oversee the project timeline and engage in project management activities, collaborating with suppliers and managing external engagements.

  • Process Design: Innovate and refine processes and equipment to boost operational efficiency.
  • Process Control: Implement control measures through validation strategies, data interpretation, and statistical process management techniques.
  • Documentation Skills: Exhibit strong communication abilities to oversee projects, liaise with vendors, develop test plans, and present actionable reports.
  • Organizational Skills: Effectively prioritize and manage tasks, including unplanned troubleshooting activities.
  • Work Environment: Ensure a safe and organized workspace for oneself and colleagues.
  • Professionalism: Demonstrate urgency, sound judgment, and a commitment to quality workmanship.
  • Self-Motivation: Ability to work autonomously as well as collaboratively within a team.
  • Communication: Maintain open lines of communication with supervisors regarding task progress and job-related issues.

Qualifications:

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

Preferred Skills:

Proficiency in Microsoft Office Suite, as well as experience with Agile, Minitab, or similar quality management/statistical analysis tools.