Validation Engineer

Syner-G•Plainville, MA

2d•Remote

About The Position

Syner-G is seeking a Validation Engineer with 4–7 years of experience 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 strong emphasis on qualification records managed within the Kneat validation platform. The Validation Engineer collaborates with cross-functional teams to ensure validation activities comply with GMP regulations, data integrity requirements, internal quality standards, and project timelines. The position supports operational readiness, technology transfer, change management, and continuous improvement initiatives. The employee may work remotely, with flexible working hours, or at one of the company’s listed office locations.

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 in 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.
Ability to use a computer keyboard and mouse; reach with hands and arms; talk and listen; frequently walk and sit; lift and carry objects weighing up to 25 pounds; and occasionally stand, stoop, or kneel. Close vision and ability to adjust focus are required.

Responsibilities

Develop, review, execute, and maintain commissioning, qualification, and validation protocols and reports within the Kneat validation system.
Generate and execute validation lifecycle documentation, including FAT, SAT, IQ, OQ, PQ, and CSV deliverables for equipment, utilities, facilities, laboratory systems, manufacturing processes, and other GMP-regulated assets.
Author, execute, review, and close validation documents, including validation plans, risk assessments, protocols, reports, discrepancy investigations, and summary reports.
Support qualification and validation activities for analytical laboratory equipment, manufacturing systems, and computerized systems in accordance with applicable regulatory requirements.
Support technology transfer projects through validation planning, protocol execution, documentation review, and qualification activities.
Develop and revise validation documentation, including 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 ensure successful execution of 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 activities for controlled environments and temperature-controlled systems.
Support regulatory inspections, audits, and remediation activities related to validation and qualification programs.
Perform periodic reviews, requalification activities, and lifecycle management of validated systems and equipment.
Ensure validation documentation complies with current GMP requirements, data integrity expectations, Good Documentation Practices (GDP), and company procedures.
Independently manage assigned validation projects while communicating status, risks, resource needs, and project milestones.