GMP Validation Director – Calibration & Compliance

Sharp Services, LLC; Lee, Northern (MA, KY); Hybrid; USD 100,000 - 160,000; Full time

Job summary

Sharp Services, LLC seeks an Associate Director of Validation in Lee, MA to lead GMP plant calibration, commissioning, qualification, and validation efforts. You will guide protocol development, reporting, and cross‑functional collaboration on complex projects ensuring strict, compliant operations.

The role requires strong problem‑solving, excellent written and verbal communication, and the ability to oversee multiple validation activities across equipment and systems.

Qualifications

• Bachelor's degree in STEM required.
• Master’s degree in STEM or four (4) years of relevant work experience.
• Excellent written and verbal communication skills.

Responsibilities

• Plan, organize, direct and control validation-related work activities.
• Manage requirements for new equipment needs.
• Oversee factory/site acceptance testing of equipment, including development of protocols, execution, and reporting.
• Supervise installation, operational, and performance qualification testing.
• Maintain validation, calibration, and maintenance schedules.
• Review and approve protocols, SOPs, plans, and specifications.
• Attend client meetings to provide validation expertise.
• Train and manage Validation Engineers and Technicians.

Skills

Executive leadership

Verbal communication

Written communication

Mechanical aptitude

Data analysis

Statistics

Applied mathematics

Engineering concepts

Detail orientation

Education

Bachelors in STEM

Masters in STEM or 4 years experience

Job description

Sharp Services, LLC seeks an Associate Director of Validation in Lee, MA to lead GMP plant calibration, commissioning, qualification, and validation efforts. You will guide protocol development, reporting, and cross‑functional collaboration on complex projects ensuring strict, compliant operations.

The role requires strong problem‑solving, excellent written and verbal communication, and the ability to oversee multiple validation activities across equipment and systems.