MSAT Validation SME

About The Company Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India.

We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Position: MSAT Validation SME

Location: Raleigh, North Carolina

Duration: Long Term

Job Overview 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.

Key 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.

Required Qualifications 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.

How To Apply Apply Now: Submit your updated resume to Stark Pharma Solutions Inc. for consideration.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.