Senior Validation Engineer - GMP Compliance Leader

Creative Solutions Services, LLC; Montpelier (VT); On-site; USD 100,000 - 140,000; Full time

Job summary

Creative Solutions Services, LLC in Montpelier, VT seeks an experienced Senior Validation Specialist to lead qualification and validation activities in a GMP environment. You will plan, execute, review, and approve validation docs for equipment, facilities, processes, and computerized systems; ensuring FDA/EMA compliance.

You will mentor junior engineers, manage deviations and CAPAs, and collaborate with cross-functional teams to drive QMS improvements and inspections readiness.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Biotechnology, Pharmacy, Chemistry, or related field.
• Minimum 5+ years of validation experience in a GMP-regulated environment.
• Strong knowledge of IQ/OQ/PQ, Process Validation, Equipment Qualification, CSV, and CAPA.
• Experience with FDA/EMA guidelines and data integrity requirements; excellent documentation.

Responsibilities

• Lead validation lifecycle activities including DQ, IQ, OQ, and PQ.
• Author, review, and approve validation protocols, reports, risk assessments, and plans.
• Execute equipment, process, cleaning, utility, facility, and CSV validation tasks.
• Support C&Q of new equipment and manufacturing systems.
• Manage deviations, investigations, CAPAs, and change controls.
• Develop and maintain Validation Master Plans (VMPs).
• Ensure compliance with cGMP, GxP, FDA/EMA and data integrity.
• Support regulatory inspections and internal/external audits.
• Collaborate with Engineering, QA, Manufacturing, Automation, and Regulatory teams.

Skills

Validation lifecycle

GxP knowledge

Technical writing

Mentorship

Education

Bachelor's degree in Engineering

Bachelor's degree in Life Sciences

Tools

Kneat

ValGenesis

TrackWise

MasterControl

Job description

Creative Solutions Services, LLC in Montpelier, VT seeks an experienced Senior Validation Specialist to lead qualification and validation activities in a GMP environment. You will plan, execute, review, and approve validation docs for equipment, facilities, processes, and computerized systems; ensuring FDA/EMA compliance.

You will mentor junior engineers, manage deviations and CAPAs, and collaborate with cross-functional teams to drive QMS improvements and inspections readiness.