GMP Process Specialist

3 weeks ago


Mechanicsville, Virginia, United States NavitsPartners Full time
Job Overview

We are seeking a highly skilled GMP Process Specialist to join our team at NavitsPartners. As a key member of our operations team, you will be responsible for ensuring the smooth execution of our manufacturing processes, maintaining regulatory compliance, and driving process improvements.

Key Responsibilities
  • GMP Training & Resources: Develop and manage GMP training materials and resources to ensure compliance with regulatory requirements.
  • Process Oversight: Serve as the primary point of contact for managing the front half of the manufacturing process, ensuring seamless execution and identifying areas for improvement.
  • On-Call Support: Provide 24/7 support to handle process issues, ensuring minimal downtime and maintaining production schedules.
  • Training & Mentorship: Provide training and guidance to new engineers, ensuring they are equipped to handle their responsibilities effectively.
  • Water Systems: Assist in the management of the factory's water systems process, ensuring compliance with regulatory requirements.
  • Project Leadership: Lead large-scale projects, including updating vessel diagrams, revising process rosters, and renaming equipment, with a focus on process improvements and efficiency gains.
  • Manufacturing Floor Interaction: Spend time on the floor gathering feedback from machine operators and other workers to troubleshoot processing issues, revise documents, collect data, conduct hazard reviews, and provide operator training.
  • Office Duties: Analyze data, perform root cause analysis, revise documents, compile and author periodic regulatory compliance reports, conduct hazard reviews, and review equipment design and compliance requirements.
Qualifications
  • Education: Bachelor's degree in Chemical, Biochemical, or Mechanical Engineering; Master's degree candidates will also be considered.
  • Industry Experience: Pharmaceutical industry experience preferred, especially with knowledge of cGMPs, chemical reaction, and purification unit operations.
  • Documentation Expertise: Knowledge of engineering documentation required for cGMP process equipment, including document revision/creation, operator training, incident investigation, hazard reviews, and data collection/analysis.
  • Experience Level: 1-2 years of experience is preferred, but not required.
  • Skills: Mechanical aptitude, proficiency in Microsoft Word and Excel.
  • Relevant Tools: API and SAP ECC experience, along with familiarity with cGMP and GMP practices.
  • CAPA Experience: Experience with Corrective and Preventative Actions (CAPA) is helpful.


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