GMP Production Technician

1 week ago


Frederick, Maryland, United States Intelliswift Software Full time

Position: GMP Production Technician

Location: Frederick, MD

Contract Duration: 12 Months

Job Overview

The GMP Production Technician will be responsible for executing and/or verifying all activities related to the production of commercial products in accordance with established batch records and standard operating procedures (SOPs). This role is essential in ensuring safe and compliant operations while collaborating closely with various departments including Materials Management, Quality Control, and Quality Assurance.

Key Responsibilities:

  1. Effectively troubleshoot processing and equipment challenges while keeping management informed of any issues.
  2. Complete necessary training to uphold technical expertise and ensure adherence to current Good Manufacturing Practices (cGMP).
  3. Draft and/or update SOPs that are technically accurate, provide clear guidance, and align with cGMP standards to enhance operational efficiency.
  4. Regularly monitor, clean, prepare, and operate advanced automated cell processing, cell expansion, and filling machinery within controlled clean room environments.
  5. Utilize all required personal protective equipment (PPE) and adhere to gowning protocols for classified GMP manufacturing areas as provided by the organization.
  6. Identify opportunities for enhancing manufacturing efficiency and compliance while assisting with investigations, deviations, and change controls.

Essential Qualifications:

  • Bachelor's degree in a scientific discipline.
  • Associate's degree with a minimum of 1 year of cGMP experience.
  • High school diploma with at least 2 years of cGMP experience.


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