GMP Validation Engineer

Position : GMP Validation Engineer

Location : Central Islip, NY

Experience : 5+ years

Contract Duration : 12+ months

Role Summary :

The GMP Validation Engineer ensures that products, equipment, and systems comply with all safety, quality, and regulatory requirements. This role involves developing and implementing validation plans, conducting tests, analyzing data, and maintaining thorough documentation of results.

Key Responsibilities :

Assist in developing qualification protocols and associated reports while adhering to change management processes.

Support execution of equipment, systems, and vendor qualification functions.

Contribute to the creation of written procedures for operation and preventive maintenance of equipment and systems.

Assist in preparing validation / qualification deliverables, including Requirements Specifications, Risk Assessments, Traceability Matrices, and Validation Summary Reports.

Support internal teams in procurement, operation, calibration, and preventive maintenance of equipment and systems, ensuring compliance with schedules and business needs.

Accurately complete calibration, qualification, and validation documentation in compliance with regulatory standards.

Respond promptly to equipment qualification, system validation, and support requests.

Maintain positive team interactions and foster a collaborative work environment.

Qualifications :

Bachelor's degree in Engineering or Biological Sciences.

Minimum 2 years of experience in validation and quality assurance within the pharmaceutical industry.

At least 1 year of direct experience in equipment validation / qualification, utility, and facility qualifications.

Hands-on experience with GAMP 5 systems and 21 CFR Part 11 compliance.

Strong understanding of pharmaceutical regulatory compliance requirements, including US and EU / MHRA data integrity guidelines.

Ability to work effectively in a cross-functional team within a dynamic environment.

Strong communication skills with team members, contractors, and vendors.