Validation Engineer

About the Company

Syner-G enables people to build careers that positively impact their quality of life. We accelerate breakthrough science and deliver life-enhancing therapies by supporting organizations through critical phases of drug discovery, approval, and commercialization. Our work is meaningful, varied, and solutions-driven, with real-world outcomes from science to delivery.

Our culture aligns with our mission, fostering growth, learning, and recognition. Syner-G has been honored with BioSpace's "Best Places to Work" award for three consecutive years, reflecting our commitment to a positive work environment, career development, financial rewards, and innovation. Team members are our most valuable asset, and we invite you to join us in shaping the future where your contributions make a meaningful impact.

About the Role

The Validation Engineer will assist with the development and execution of validation protocols for various processes, driving overall quality performance and compliance. This role involves defining, implementing, and maintaining the validation program to ensure adherence to regulatory standards and organizational goals.

Responsibilities

• 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 client projects, including generation, execution, review, and closure of validation life cycle documents.
• Write, review, and revise Installation, Operation, and Performance qualification/verification documents, such as SOPs, validation master plans, guidelines, execution plans, automation, engineering design, commissioning, qualification, 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 to summarize validation, verification, commissioning, and/or revalidation activities.
• Develop procedures, investigations, protocols, reports, and change controls to support validation execution and closeout.
• Perform execution support activities, including P&ID walkdowns, drawing reviews, and ETOP verification.
• Conduct 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.

Requirements

• Bachelor’s degree in a related life science field.
• 3-10 years of experience within the biotech, pharmaceutical, or medical device industry.
• Knowledge and experience working with FDA cGMP, FMEA, and Risk Analysis.
• Expertise in Process Equipment, Utilities, Clean Room, and/or Computer Systems validation.
• Hands-on equipment start-up and troubleshooting experience is highly desired.
• Report writing experience for IQ, OQ, PQ.

Skills

• Strong verbal and written communication skills, with the ability to discuss technical topics with both stakeholders and non-technical audiences.

Physical Demands

The role requires regular use of a computer keyboard and mouse, reaching with hands and arms, talking, and listening. The employee will frequently walk, sit, and lift/carry objects up to 25 pounds. Occasional standing, stooping, or kneeling may be required. Specific vision abilities include close vision and the ability to adjust focus.

Work Environment

The work environment is indoor with moderate noise levels, temperate conditions, and bright lighting conducive to minimal eye strain, typical of an office setting.

Benefits

• Market-competitive base salary and annual incentive plan.
• Robust benefit offerings.
• Generous flexible paid time off program and company-paid holidays.
• Flexible working hours and fully remote work options for most positions.
• Ability to work "almost anywhere" or from office locations in Greater Boston, San Diego, Boulder, or India.
• Ongoing recognition and career development opportunities.

Syner-G is currently unable to sponsor or take over sponsorship of an employment visa.