Senior Validation Engineer — GMP Equipment Qualification Lead

Harba Solutions Inc.; Indiana (PA); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Paid vacation

Paid sick time

11 holidays

401(k) with company match

Job summary

Harba Solutions Inc. is seeking a Senior Validation Engineer to drive qualification and validation for a sterile injectable manufacturing facility.

This role is a key individual contributor within the Validation Department, collaborating with internal teams and clients to ensure compliant validation practices. The ideal candidate has 5–8 years in Validation, 4+ years GMP experience, and is comfortable working onsite to support facility upgrades, capital projects, and laboratory systems

Qualifications

• Bachelor’s degree or higher in a STEM discipline.
• 5–8 years of experience in Validation or a related discipline.
• 4+ years of GMP experience (or other regulated industry).
• Ability to work onsite.

Responsibilities

• Perform qualification activities on utilities, equipment, and laboratory systems.
• Interact with clients to provide validation support for product launches and qualifications.
• Support capital expansion projects and build-outs.
• Develop and modify SOPs, Work Instructions, and guidelines for equipment validation.
• Review facility changes and advise on re-validation and re-qualification.
• Assess risks and define validation deliverables.
• Engage cross-functionally with Engineering and Operations.
• Track industry trends and propose program updates.

Job description

Harba Solutions Inc. is seeking a Senior Validation Engineer to drive qualification and validation for a sterile injectable manufacturing facility.

This role is a key individual contributor within the Validation Department, collaborating with internal teams and clients to ensure compliant validation practices. The ideal candidate has 5–8 years in Validation, 4+ years GMP experience, and is comfortable working onsite to support facility upgrades, capital projects, and laboratory systems