Senior Validation Engineer

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
• Computer System Validation experience
• Cleaning Validation experience
• VHP & Steam Sterilization experience

Benefits:

• Paid vacation (tenure-based) and paid sick time
• 11 observed holidays
• 401(k) with company match up to 3.5%, vested immediately
• Choice of health & wellness plans
• FSA and HSA programs
• Dental & vision care