Validation Engineer

Syner-G•Plainville, MA

3d•Remote

About The Position

Syner-G is seeking a Validation Engineer to support commissioning, qualification, validation (CQV), and computer system validation (CSV) activities across equipment, utilities, facilities, laboratory systems, manufacturing processes, and computerized systems. The role develops, executes, reviews, and maintains validation lifecycle documentation, with a particular emphasis on qualification records managed in the Kneat validation platform. The engineer works with cross-functional teams to ensure activities meet GMP regulations, data integrity requirements, internal quality standards, and project timelines, while supporting operational readiness, technology transfer, change management, and continuous improvement. The position involves independently managing assigned validation projects and communicating project status, risks, resource needs, and milestones. It also supports regulatory inspections, audits, and remediation, as well as periodic reviews, requalification, and lifecycle management of validated systems and equipment. The position requires a bachelor’s degree in a life science, engineering, or related technical field and 4–7 years of relevant industry experience. The role’s physical demands include regular use of a computer keyboard and mouse, reaching, talking, and listening; frequent walking and sitting; occasionally standing, stooping, or kneeling; and lifting or carrying objects weighing up to 25 pounds. The work environment is described as an indoor, temperate office environment with moderate noise and bright lighting. Syner-G offers remote work options for most positions, flexible working hours, generous flexible paid time off, company-paid holidays, a market-competitive base salary, an annual incentive plan, benefits, recognition, and career development opportunities.

Requirements

Bachelor’s degree in a life science, engineering, or related technical field.
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 with 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.
Strong verbal and written communication skills, including 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.
Strong problem-solving skills and ability to support investigations and root-cause analysis.

Responsibilities

Develop, review, execute, and maintain commissioning, qualification, and validation protocols and reports in the Kneat validation system.
Generate and execute validation lifecycle documentation, including FAT, SAT, IQ, OQ, PQ, and CSV deliverables for GMP-regulated assets and systems.
Author, execute, review, and close validation plans, risk assessments, protocols, reports, discrepancy investigations, and summary reports.
Support qualification and validation of analytical laboratory equipment, manufacturing systems, and computerized systems in accordance with applicable regulatory requirements.
Support technology transfer through validation planning, protocol execution, documentation review, and qualification activities.
Develop and revise SOPs, Master Validation Plans, execution plans, URS, FRS, design specifications, commissioning protocols, verification protocols, and test procedures.
Collaborate with Engineering, Manufacturing, Quality Assurance, Quality Control, and project teams to execute validation activities.
Support change controls, impact assessments, deviation investigations, CAPAs, and validation assessments for GMP systems and processes.
Perform P&ID walkdowns and system inspections to verify installation and operational readiness.
Conduct thermal mapping studies and support qualification of controlled environments and temperature-controlled systems.
Support validation-related regulatory inspections, audits, and remediation activities.
Perform periodic reviews and requalification, and manage validated systems and equipment throughout their lifecycle.
Ensure validation documentation complies with current GMP requirements, data integrity expectations, Good Documentation Practices, and company procedures.
Independently manage assigned validation projects and communicate status, risks, resource needs, and project milestones.