Senior Validation Engineer

Job Title:
Senior Validation Engineer

Job Overview:
The Senior Validation Engineer will provide technical expertise and hands-on support for validation activities within a sterile injectables manufacturing facility. This role is responsible for developing, executing, and maintaining validation programs for equipment, utilities, laboratory systems, and capital projects. The ideal candidate will have strong subject matter expertise in qualification and validation, with the ability to collaborate cross-functionally, adapt to evolving project needs, and ensure compliance with regulatory requirements.

Job Responsibilities:

• Perform qualification activities for clean utilities, autoclaves, washers, fillers, laboratory instruments, and controlled temperature units.

• Partner with clients to provide validation support for product launches and new equipment qualifications.

• Support validation oversight for capital expansion projects and facility build-outs.

• Develop, review, and maintain SOPs, work instructions, and guidelines for validation policies, procedures, and templates.

• Evaluate facility changes and provide input on re-validation or re-qualification requirements.

• Assess risks associated with equipment and processes, ensuring validation requirements and design deliverables are met.

• Collaborate with Engineering, Operations, and other cross-functional teams to support validation and process improvements.

• Conduct validation activities in accordance with approved protocols, documenting results and identifying protocol excursions.

• Stay informed on industry trends and regulatory expectations to ensure validation programs remain current and compliant.

Qualifications:

• Bachelor’s degree in a STEM discipline required.

• 5 to 8 years of experience in validation or a related discipline.

• Minimum of 4 years of GMP or regulated industry experience.

• Demonstrated expertise in equipment and process validation within pharmaceutical manufacturing.

• Strong ability to collaborate across teams and influence positive outcomes without direct reporting authority.

• Onsite presence required to support manufacturing operations.

• Master’s degree preferred.

• Experience with computer system validation, cleaning validation, VHP, and steam sterilization preferred.