Validation Engineer

Company Overview

Syner‑G is a strategic biopharma product development and delivery partner that accelerates breakthrough science and life‑enhancing therapies. The company supports clients across drug discovery, approval, and commercialization phases, emphasizing a solutions‑driven approach and real‑world outcomes. Recognized as BioSpace’s “Best Places to Work” 2026 for three consecutive years, Syner‑G focuses on culture, career growth, financial rewards, leadership, and innovation.

Position Overview

The Validation Engineer will support validation activities for equipment, utilities, facilities, computerized systems, manufacturing processes, and MES/eBR platforms in GMP‑regulated environments. Responsibilities include developing, executing, reviewing, and maintaining validation lifecycle documentation while ensuring compliance with regulatory requirements, data integrity standards, and internal quality procedures. The role works closely with Manufacturing, Validation, Automation, IT/OT, and Quality teams.

Key Responsibilities

• Generate and execute validation lifecycle documentation (FAT, SAT, IQ, OQ, PQ, validation reports) for GMP‑regulated assets.
• Provide validation support and oversight for MES and eBR implementation, qualification, and lifecycle management.
• Review requirements, risk assessments, traceability matrices, test protocols, deviations, and validation reports for compliance.
• Review eBR workflows to ensure alignment with manufacturing processes, master batch records, and regulatory requirements.
• Support compliance with 21 CFR Part 11, GMP, data integrity, and computerized systems validation (CSV) requirements.
• Assist with deviation investigations, CAPAs, change controls, system releases, and go‑live readiness activities.
• Author, execute, review, and maintain validation documentation (plans, protocols, reports, SOPs, URS, FRS, design specifications).
• Support technology transfer projects by executing and documenting validation activities per project timelines.
• Prepare validation summary reports and support qualification/re‑qualification activities.
• Participate in commissioning and qualification activities, including system walkdowns and verification exercises.
• Support thermal mapping and validation for temperature‑controlled environments as applicable.
• Assist in resolving audit observations, regulatory findings, and manufacturing issues related to validation and computerized systems.
• Collaborate with cross‑functional teams to ensure successful project execution and operational readiness.
• Maintain validation documentation in accordance with quality system requirements and document control procedures.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Computer Systems, or a related technical field.
• 4–7 years of validation experience in the pharmaceutical, biotechnology, medical device, or other regulated life‑sciences industry.
• Experience supporting equipment qualification, CSV, process validation, or automation system validation.
• Proven ability to author and execute validation documentation (IQ, OQ, PQ protocols, validation reports).
• Familiarity with risk‑based validation methodologies and GMP regulatory expectations.
• Preferred: Experience with MES/eBR platforms (e.g., PAS‑X, PharmaSuite, Syncade, Opcenter) and supporting audits, inspections, deviation investigations, CAPAs, and change controls.

Knowledge, Skills, and Abilities

• Understanding of GMP manufacturing operations, 21 CFR Part 11, data integrity principles, and CSV requirements.
• Demonstrated experience supporting MES/eBR validation or computerized system qualification in a regulated environment.
• Strong technical writing and documentation skills with meticulous attention to detail.
• Ability to review and interpret validation documentation, process flows, requirement specifications, and test scripts.
• Excellent organizational, analytical, and problem‑solving abilities.
• Effective verbal and written communication skills for cross‑functional collaboration.
• Capability to manage multiple assignments and priorities in a fast‑paced project environment.
• Working knowledge of validation lifecycle deliverables and quality system processes.
• Self‑directed yet effective within cross‑functional teams.

Physical Demands

The role requires regular use of a computer keyboard and mouse, reaching with hands and arms, talking, and listening. Frequent walking and sitting are expected, with occasional lifting of objects up to 25 lb (e.g., books, files). Occasional standing, stooping, or kneeling may be required. Vision requirements include close vision and the ability to adjust focus.

Work Environment

The work environment is an indoor office setting with moderate noise levels, a temperate climate, and bright lighting designed to minimize eye strain.

Total Rewards

Syner‑G offers a market‑competitive base salary, annual incentive plan, robust benefit offerings, generous flexible paid time off, company‑paid holidays, flexible working hours, and fully remote work options for most positions. Office locations are available in Greater Boston, San Diego (CA), Boulder (CO), and India. The company currently does not sponsor employment visas.