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Process Validation Specialist

2 months ago

Columbia, South Carolina, United States Technical Source Full time

Technical Source is seeking skilled Validation Engineers to engage in process validation initiatives that support cGMP pharmaceutical production environments. In these positions, you will collaborate with team members to establish process control parameters and develop validation protocols aimed at assessing and confirming process integrity.

This role requires full on-site presence, with flexibility to accommodate rotating shifts. These are long-term contract positions that do not support sponsorship or C2C employment arrangements.

Key Responsibilities

  • Develop and author comprehensive Process Validation plans, which may involve creating product-specific process requirements and drafting specifications for executing performance qualifications and media fill simulations.
  • Conduct technical reviews and author deviations and planned deviations, manage change controls, monitor processes, and oversee lot release activities.
  • Assist in evaluating the implications of change control on qualified processes and aseptic operations.
  • Collaborate effectively with other validation professionals and ensure seamless cross-departmental cooperation.