MSAT Validation SME

About the role

We are seeking an experienced MSAT Validation SME to support a pharmaceutical expansion project. The role will focus on MSAT, validation, technology transfer, process validation, CSV, and project management activities during the launch and expansion of a new manufacturing facility.

Responsibilities

• Support MSAT activities for new facility expansion and manufacturing projects.
• Support implementation and validation of Electronic Batch Record (EBR) systems.
• Support technology transfer and process validation activities.
• Drive continuous improvement and process optimization initiatives.
• Support CSV activities including URS, FRS, IQ, OQ, and PQ.
• Develop and support validation documentation and risk assessments.
• Coordinate and facilitate MSAT projects with cross-functional teams.
• Support project planning, execution, and tracking.
• Work closely with Manufacturing, Quality, Engineering, IT, and other project teams.
• Provide technical guidance and ensure projects remain on schedule.
• Communicate project status, issues, and actions to stakeholders.

Requirements

• Strong experience in MSAT within a pharmaceutical manufacturing environment.
• Experience with Computer System Validation (CSV).
• Experience with Electronic Batch Record (EBR) systems.
• Strong experience with technology transfer and process validation.
• Experience with URS, FRS, IQ, OQ, and PQ activities.
• Experience performing validation risk assessments.
• Strong project management and coordination skills.
• Experience supporting new facility or manufacturing expansion projects.
• Strong communication and cross-functional collaboration skills.