Senior Validation Engineer - Sterile Injectables

Harba Solutions Inc.; Indiana (PA); On-site; USD 100,000 - 150,000; Full time

Benefits offered by this job

Paid vacation (tenure-based)

Paid sick time

11 observed holidays

401(k) with company match up to 3.5%

Job summary

Harba Solutions Inc. is seeking a Senior Validation Engineer to lead qualification efforts in a sterile injectables facility.

The role focuses on developing and implementing validation protocols and ensuring GMP compliance across utilities, equipment, and lab systems. The position involves collaborating with internal customers on client projects, facility upgrades, and capital expansions, while owning SOP development and validation templates to support continuous improvements.

Qualifications

• Bachelor's degree or higher in a STEM discipline.
• 5–8 years of Validation or 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 new equipment qualifications.
• Support and provide validation oversight for capital expansion projects and build-outs.
• Own the development and modification of SOPs, work instructions, and guidelines for equipment validation policies.
• Review facility changes and provide input on re-validation and re-qualification of equipment.
• Assess risks in processing steps related to equipment; develop validation requirements and deliverables.
• Engage cross-functionally with Engineering and Operations to support validation and process improvements.
• Conduct validation qualifications per applicable protocols and identify protocol excursions.
• Track industry trends in validation and regulatory expectations, proposing program updates as needed.

Skills

Validation expertise

Sterile injectable manufacturing

GMP compliance

Cross-functional collaboration

Education

Bachelor's degree in STEM

Master's degree preferred

Tools

Qualification protocols

Job description

Harba Solutions Inc. is seeking a Senior Validation Engineer to lead qualification efforts in a sterile injectables facility.

The role focuses on developing and implementing validation protocols and ensuring GMP compliance across utilities, equipment, and lab systems. The position involves collaborating with internal customers on client projects, facility upgrades, and capital expansions, while owning SOP development and validation templates to support continuous improvements.