MSAT Validation SME

About the role

Our pharmaceutical client is seeking an experienced MSAT & Validation SME to support a major new site expansion project in Greenville, NC. The ideal candidate will have a strong background in Manufacturing Science & Technology (MSAT), process validation, technology transfer, CSV, and project management. The consultant will support the implementation and validation of new manufacturing processes and electronic batch record systems as the new facility comes online.

Responsibilities

• Support MSAT activities associated with the new site expansion and facility launch.
• Lead/support technology transfer and process implementation activities.
• Support process validation and continuous improvement initiatives.
• Assist with implementation, validation, and management of Electronic Batch Record (EBR) systems.
• Support Computer System Validation (CSV) activities, including:
  • URS
  • FRS
  • IQ
  • OQ
  • PQ
• Develop and participate in risk assessments and validation documentation.
• Help manage and coordinate projects across multiple onsite teams.
• Facilitate project meetings and drive action items to completion.
• Collaborate closely with MSAT, Engineering, Quality, IT, Manufacturing, Validation, and other cross-functional teams.
• Ensure processes and systems are properly established and ready for successful site launch.
• Provide strong technical and project leadership throughout the expansion.

Required Skills

• MSAT / Manufacturing Science & Technology
• Computer System Validation (CSV)
• Process Validation
• Technology Transfer
• Project Management
• Electronic Batch Records / EBR
• URS, FRS, IQ, OQ, PQ
• Risk Assessments
• Strong communication and cross-functional collaboration skills
• Pharmaceutical / GMP manufacturing experience

Ideal Candidate

The ideal candidate will be a hands-on MSAT and Validation SME with strong pharmaceutical manufacturing experience who can bridge process, validation, technology, and project management activities during a new facility expansion.