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Validation Sme Jobs (NOW HIRING)

JS Consulting

CSA Validation Subject Matter Expert (SME) High Priority, ASAP Start Long Island City Queens NY Location: Hybrid onsite at LIC (3 days per week), must be local Duration: 6 months to start, Possible ...

Biovire

Director, Validation

Brighton, MI · On-site

$100K - $120K/yr

The position will also represent Biovire as the senior Validation SME during FDA and other regulatory inspections and client audits, including presenting and defending validation strategies and ...

Biovire

Director, Validation

Brighton, MI · On-site

The position will also represent Biovire as the senior Validation SME during FDA and other regulatory inspections and client audits, including presenting and defending validation strategies and ...

Biovire, Inc.

Director, Validation

Brighton, MI · On-site

The position will also represent Biovire as the senior Validation SME during FDA and other regulatory inspections and client audits, including presenting and defending validation strategies and ...

Inherent Technologies

CSV Lead Consultant

Chandler, AZ · Remote

... CSA, Validation SME, and Test Manager as required by CSL QMS - Build and manage relationship with regional stakeholders including gathering and resolving feedback - Review system assurance and ...

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As of Sep 14, 2026, the average hourly pay for validation sme in the United States is $52.00, according to ZipRecruiter salary data. Most workers in this role earn between $39.42 and $63.22 per hour, depending on experience, location, and employer.

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Infographic showing various Validation Sme job openings in the United States as of August 2026, with employment types broken down into 91% Full Time, 4% Part Time, and 5% Contract. Highlights an 84% Physical, 5% Hybrid, and 11% Remote job distribution, with an average salary of $108,152 per year, or $52 per hour.

MSAT Validation SME

Raleigh, NC • On-site

Stark Pharma Solutions Inc
See more jobs at Stark Pharma Solutions Incexternal

Contractor

Posted 13 days ago

Job description

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.