Associate Director, Validation & GMP Calibration Leadership

SHARP STERILE MANUFACTURING LLC; Lee (MA); On-site; USD 100,000 - 160,000; Full time

Job summary

SHARP STERILE MANUFACTURING LLC in Lee, MA seeks an Associate Director of Validation to lead GMP calibration, commissioning, qualification and validation programs. You will manage protocols, reports, and scheduling for equipment qualification and maintenance.

Requirements include 8–10 years in management, a STEM bachelor’s (master’s preferred), excellent written and verbal communication, and strong data analysis skills. This full-time role reports to the VP of Engineering.

Qualifications

• Excellent written and verbal communications skills.
• Broad knowledge of engineering concepts and aseptic operations, validation.
• Strong mechanical aptitude.
• Proficient with data analysis, statistics and applied mathematics.

Responsibilities

• Plan, organize, direct and controls the work activities related to validation.
• Manage requirements for new equipment needs.
• Manage factory and site acceptance testing of equipment, including development of protocols, execution, and report writing.
• Manage installation, operational, and performance qualification testing of equipment, including development of protocols, execution, and report writing.
• Manage requalification, preventative maintenance, and calibration plans for equipment.
• Manage the validation, calibration, and maintenance schedules.
• Review and approve validation protocols, SOPs, plans, and specifications.
• Attend client facing meetings to provide expertise on matters concerning validation topics.
• Other duties as assigned by the VP of Engineering.

Skills

Communication skills

Mechanical aptitude

Engineering knowledge

Data analysis

Education

Bachelor's in STEM

Master's in STEM or 4 years experience

Job description

SHARP STERILE MANUFACTURING LLC in Lee, MA seeks an Associate Director of Validation to lead GMP calibration, commissioning, qualification and validation programs. You will manage protocols, reports, and scheduling for equipment qualification and maintenance.

Requirements include 8–10 years in management, a STEM bachelor’s (master’s preferred), excellent written and verbal communication, and strong data analysis skills. This full-time role reports to the VP of Engineering.