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Process Validation Specialist

2 months ago

Columbia, South Carolina, United States Technical Source Full time

Overview

Technical Source is seeking Validation Engineers to engage in critical process validation tasks within the realm of cGMP pharmaceutical production. In these positions, you will collaborate with colleagues to establish process control parameters and develop validation protocols aimed at assessing and confirming process reliability.

This role requires full on-site presence, with a need for flexibility in working rotating shifts. These are long-term contract positions, and we are unable to accommodate sponsorship or C2C employment at this time.

Key Responsibilities

  • Draft and author comprehensive Process Validation plans, which may involve creating product-specific process requirements and specification drafts to facilitate process performance qualifications and media fill simulations.
  • Conduct technical reviews and author deviations and planned deviations, manage change controls, oversee process monitoring, and carry out activities related to lot releases.
  • Assist in evaluating the implications of change control on qualified processes and aseptic operations.
  • Collaborate effectively with validation team members and maintain strong cross-functional relationships with other departments.