Senior Validation & GMP Compliance Leader

Berkshire Sterile Manufacturing Llc; Lee (MA); On-site; USD 100,000 - 160,000; Full time

Job summary

Berkshire Sterile Manufacturing Llc in Lee, MA is seeking an Associate Director of Validation to lead GMP plant calibration, commissioning, qualification and validation programs. The role requires strong problem solving, communication skills and proficiency with spreadsheets, word processors, emails, and PCs.

You will supervise Validation Engineers and Technicians, develop validation protocols, manage equipment validation and calibration plans, and interact with clients in technical meetings.

Qualifications

• Bachelor's degree in STEM is required.
• Master’s degree in STEM or four years of relevant work experience.
• Excellent written and verbal communications skills.
• Strong mechanical aptitude.
• Broad knowledge of engineering concepts, aseptic operations, and validation.
• Proficiency with data analysis, statistics and applied mathematics.

Responsibilities

• Plan, organize, direct and control validation activities.
• Manage requirements for new equipment needs.
• Manage factory/site acceptance testing of equipment including development of protocols and reports.
• Manage installation, operational and performance qualification testing of equipment.
• Manage validation, calibration and maintenance schedules.
• Review and approve validation protocols, SOPs, plans and specifications.
• Attend client-facing meetings to provide validation expertise.
• Other duties as assigned by VP of Engineering.

Education

Bachelor's degree in STEM

Master’s degree in STEM or four years of relevant work experience

Tools

Job description

Berkshire Sterile Manufacturing Llc in Lee, MA is seeking an Associate Director of Validation to lead GMP plant calibration, commissioning, qualification and validation programs. The role requires strong problem solving, communication skills and proficiency with spreadsheets, word processors, emails, and PCs.

You will supervise Validation Engineers and Technicians, develop validation protocols, manage equipment validation and calibration plans, and interact with clients in technical meetings.