Associate Director of Validation

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

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Associate Director of Validation

Full Time Management Lee, MA, US

5 days ago Requisition ID: 1809

Salary Range: $100,000.00 To $160,000.00 Annually

Position Summary

Associate Director of Validation is primarily responsible for GMP plant calibration, commissioning, qualification, and validation. To perform this job successfully, an individual must possess good problem-solving skills, good written and verbal communications skills and must be able to work on spreadsheets, word processors, e-mails, and PCs. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Duties and 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

Regulatory Responsibilities

• Conduct business in a responsible manner that complies with all state, FDA, OSHA, EPA, and DEP regulations, or otherwise as applicable. Provide leadership in daily operations, and have employees incorporate these compliance practices into their daily routines

Supervisory Responsibilities

• Train and perform management of Validation Engineers and Validation Technicians


• Develop policies and systems related to validation, calibration, and preventive maintenance

Experience

• Minimum of eight (8) to ten (10) years of experience in management

Education

• Bachelor's degree in STEM


• Master’s degree in STEM or four (4) years of relevant work experience

Knowledge, Skills & Abilities

• Excellent written and verbal communications skills


• Strong mechanical aptitude


• Broad knowledge of engineering concepts, and aseptic operations, validation


• Knowledge of common materials, engineering methods, process controls and manufacturing systems


• Proficient with data analysis, statistics and applied mathematics


• Knowledge of design techniques, principles, tools and instruments involved in the production and use of precision technical plans, blueprints, drawings, and models


• Ability to see the \"Big Picture\" AND demonstrate the necessary \"Detail Orientation\"

Physical Requirements

• Ability to sit or stand for prolonged periods of time


• Ability to lift and carry materials weighing as much as 50lbs