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 BioSpace'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.

For more information, visit www.Synergbiopharma.com

POSITION OVERVIEW

We are seeking a Validation Engineer with 4–7 years of experience to support the development, execution, and management of validation activities across equipment, utilities, facilities, computerized systems, and manufacturing processes. This role is responsible for ensuring compliance with internal quality standards and regulatory requirements by generating, executing, and maintaining validation lifecycle documentation. The Validation Engineer will play a key role in supporting operational readiness, tech transfer, and continuous improvement initiatives.

KEY RESPONSIBILITIES

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

Generate and execute validation lifecycle documentation (FAT, SAT, IOQ, PQ) for equipment, utilities, facilities, cleaning processes, shipping systems, and other GMP‑regulated assets.

Support validation activities for internal and client tech transfer projects, including authoring, executing, reviewing, and closing validation documents such as risk assessments, validation plans, IQ, OQ, PQ, test methods, and validation reports.

Write, review, and revise qualification and verification documents, including SOPs, master validation plans, execution plans, URS, FRS, design specifications, FAT documentation, verification protocols, and commissioning test procedures.

Prepare summary reports for validation, verification, commissioning, and requalification activities.

Develop and support procedures, investigations, protocols, reports, and change controls for Maintenance, Engineering, and Quality functions.

Perform P ID walkdowns to verify installation and system readiness.

Conduct thermal mapping of temperature‑controlled chambers, warehouses, and SIP processes.

Support resolution of regulatory observations, audit findings, and manufacturing site issues related to validation.

Perform periodic reviews and requalification activities for temperature‑controlled systems and other validated assets.

QUALIFICATIONS AND REQUIREMENTS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education

Bachelor’s degree in a life science, engineering, or related technical field.

Technical Experience

4–7 years of experience in the biotech, pharmaceutical, or medical device industry.

Strong knowledge of FDA cGMP requirements, FMEA, and risk‑based validation principles.

Hands‑on validation experience in equipment, computerized systems (CSV), analytical methods, and process validation.

Experience generating protocols for automated production systems, with emphasis on computerized equipment and systems validation.

Demonstrated experience writing IQ, OQ, PQ, and CSV reports.

Knowledge, Skills, and Abilities

Strong verbal and written communication skills, with the ability to explain technical concepts to non‑technical stakeholders.

Detail‑oriented with strong organizational and documentation skills.

Ability to work independently and collaboratively in a fast‑paced, regulated environment.

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