Senior Validation Engineer

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

Are you a Validation Engineer looking for an exciting opportunity with an organization where you can make an impact on global health and wellness?

We are seeking a highly motivated Senior Validation Engineer with validation expertise to join our team. This is a key individual contributor role within our Validation Department, responsible for understanding and implementing validation requirements for a sterile injectables manufacturing facility. The ideal candidate has subject matter expertise and hands-on experience in qualification and validation.

You'll partner with internal customers to support client projects, facility upgrades, capital expansion projects, and laboratory systems — and will need a demonstrated ability to influence positive outcomes without direct reporting authority, while adapting to the evolving needs of a manufacturing environment.

Essential Job Functions:

• Perform qualification activities on utilities, equipment, and laboratory systems — including clean utilities, autoclaves, washers, fillers, laboratory instruments, and controlled temperature units
• Interact with clients to provide validation support, including customer 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, standards, procedures, and templates
• Review facility changes and provide input on re-validation and re-qualification of equipment
• Assess risks in processing steps related to equipment; develop and/or review validation requirements and design deliverables
• Engage cross-functionally with Engineering and Operations to support validation and process improvement efforts
• Conduct validation qualifications per applicable protocols and identify protocol excursions
• Track industry trends in validation and regulatory expectations, proposing program updates as needed

Requirements:

• 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

Preferred:

• Master's degree or higher
• Paid vacation (tenure-based) and paid sick time
• 11 observed holidays
• 401(k) with company match up to 3.5%, vested immediately