Validation Engineer

Validation Engineer – Bio Space

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. Below Syner-G culture, we enable our people to grow, support them in learning, and reward them in many ways. We recently received Bio Space’s prestigious “Best Places to Work” 2026 award for the third consecutive year.

We are seeking a Validation Engineer to assist with the development and execution of validation protocols for various processes. The Validation Engineer will drive overall quality performance and compliance throughout the organization by defining, implementing, and maintaining the validation program.

Travel to client sites may be required up to 100% based on project demands and client expectations.

• Generate and execute life‑cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment, and processes for (re) qualification/(re) verification.
• Support validation activities for Basecamp and client Tech Transfer projects, including generation, execution, review, and closure of validation life‑cycle documents (RA, VP, IQ, OQ, PQ, TM, VR).
• Write, review, and revise a variety of Installation, Operation, and Performance qualification/verification related documents, including SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design, commissioning, qualification or other technical documents, user requirement specifications (URS), functional requirement specifications (FRS), detailed design specifications, factory acceptance test documents (FAT), verification protocols, and/or commissioning test procedures.
• Write reports to summarize validation/verification/commissioning and/or revalidation/verification/commissioning activities.
• Write procedures, investigations, protocols, reports, change controls, etc., to support the Maintenance and Engineering departments.
• Perform P&‑downs and thermal mapping of temperature‑controlled chambers, warehouses, and SIP processes.
• Support the resolution of regulatory observations or manufacturing site issues.
• Execute periodic reviews and requalification for temperature chambers.

• Bachelor’s degree in a related life science field.

• 4‑7 years of experience within the biotech, pharmaceutical, or medical device industry.
• Knowledge and experience working with FDA cGMP, FMEA, and Risk Analysis.
• Validation expertise in Equipment, CSV, Method, and Process.
• Protocol generation experience of automated production systems, with a concentration on computerized equipment and systems validation.
• Report writing experience for IQ, OQ, PQ, and CSV.

• Strong verbal and written communication skills and the ability to discuss technical topics with non‑technical people.

• Regular use of computer keyboard/mouse, reaching, walking, sitting; lifting and carrying objects up to 25 pounds; occasional standing, stooping, or kneeling.

Moderate noise level, indoor temperate environment, and light levels that are bright and conducive to minimal eye strain—typical office environment.

Competitive base salary, annual incentive plan, robust benefit offerings, recognition and career development opportunities, flexible paid time off, company holidays, flexible working hours, and full remote work options for most positions.

The expected salary range: $88,000 to $104,000. Pay determined by experience, qualifications, location, and other factors.

Syner‑G is a proud Equal Employment Opportunity and affirmative action employer. All employment decisions are made without regard to race, color, creed, religion, sex, pregnancy, disability, sexual orientation, gender identity, political affiliation, income, residence, national origin, age, veteran status, or any other basis prohibited by law. Syner‑G is an E‑Verify employer.