Sr. Validation Engineer

COMPANY

DESCRIPTION:

A career here is life-enhancing.

At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization.

It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video here .

Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.

Syner-G was recently honored with Bio Space's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.

At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.

We are seeking a Sr. Validation Engineer with 7-11 years of experience to lead and support validation activities across equipment, utilities, facilities, computerized systems, manufacturing processes, and MES/e  platforms within GMP-regulated environments. This role is responsible for developing, executing, reviewing, and managing validation lifecycle documentation while ensuring compliance with regulatory expectations, data integrity requirements, and internal quality standards.

The Sr. Validation Engineer will serve as a subject matter expert for validation and computerized systems, providing QA/Validation oversight for Manufacturing Execution System (MES) and Electronic Batch Record (e ) implementations, qualification activities, and system lifecycle management. This individual will partner closely with Manufacturing, Quality, Validation, Automation, and IT/OT teams to ensure successful system deployment, qualification, and ongoing compliance.

(This list is not exhaustive and may be supplemented or adjusted as needed.)

• Lead the generation and execution of validation lifecycle documentation (FAT, SAT, IQ, OQ, PQ) for equipment, utilities, facilities, cleaning processes, shipping systems, computerized systems, and other GMP-regulated assets.
• Provide QA/Validation oversight for MES and e  implementation, qualification, and system lifecycle activities.
• Review and approve requirements, risk assessments, traceability matrices, validation plans, test protocols, deviations, change controls, and validation summary reports.
• Review e  workflows and electronic manufacturing processes to ensure alignment with approved manufacturing procedures, master batch records, and GMP requirements.
• Ensure compliance with applicable regulatory requirements, including 21 CFR Part 11, GMP, data integrity, computerized systems validation (CSV), and industry best practices.
• Support deviation investigations, CAPAs, change controls, system releases, and go-live readiness activities for MES/e  and other GMP computerized systems.
• Oversee validation activities for internal and client technology transfer projects, including authoring, executing, reviewing, and closing validation documentation.
• Write, review, and revise qualification and verification documents, including SOPs, Validation Master Plans, execution plans, URS, FRS, design specifications, FAT documentation, verification protocols, and commissioning test procedures.
• Prepare comprehensive validation, verification, commissioning, qualification, and requalification summary reports.
• Develop and support procedures, investigations, protocols, reports, and change controls for Maintenance, Engineering, Manufacturing, and Quality functions.
• Lead P& to…