About this opportunity
Sharp Services, LLC lists this Associate Director of Validation opportunity in lee, Massachusetts. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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Associate Director of Validation
Full Time Management Lee, MA, US
7 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
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Worksite address
lee, MA, 01238, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.