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 support many organizations from the most critical phases of the drug discovery and approval process through to commercialization.

We are meaningful, varied and thought-provoking with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes from science to delivery/success. We cultivate a culture that aligns with our mission: we enable growth, support learning and reward performance in many ways. This leads to a positive workplace recognised by Bio Space’s Best Places to Work award for 2026 and previous years, demonstrating our commitment to culture, career growth, financial rewards, leadership and innovation.

Our team members are our most valuable asset. Join us where your talents are valued and your contributions have a meaningful impact.

Syner-G is 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 by defining, implementing and maintaining the validation program.

• 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 documents such as 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 commissioning test procedures.
• Write reports summarizing validation/verification/commissioning and/or revalidation/verification/commissioning activities.
• Write procedures, investigations, protocols, reports, change controls and related documents to support the Maintenance and Engineering departments.
• Perform P&I D walk‑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 with FDA cGMP, FMEA, and risk analysis.
• Validation expertise in equipment, CSV, method and process.
• Protocol generation experience for automated production systems, particularly 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.

Physical Demands:

• Regular use of a computer keyboard and mouse; hand and arm reach; talk and listen. Frequently required to walk, sit, lift and carry objects such as books and files weighing up to 25 pounds. Occasionally required to stand, stoop or kneel. Vision requirements include close vision and the ability to adjust focus.

The work environment is an office setting with moderate noise, an indoor temperate environment and bright lighting that minimizes eye strain.

Compensation includes a market‑competitive base salary, an annual incentive plan and robust benefits. Employees enjoy generous paid time off, company‑paid holidays, flexible working hours, and a fully remote work option for most positions. For those who prefer a physical location, office locations are available in Greater Boston, San Diego, CA, Boulder, CO and India.

Syner‑G is a proud Equal Employment Opportunity and affirmative action employer. Employment decisions are made without regard to race, color, creed, religion, sex, pregnancy, appearance, family responsibilities, sexual orientation, gender identity, political affiliation, source of income, residence, national origin, ancestry, age, marital status, military veteran status, disability or any other protected characteristic. Syner‑G is an E‑Verify employer.

Mid‑Senior level

Full‑time

Quality Assurance

Pharmaceutical Manufacturing