Associate Director of Validation
SHARP STERILE MANUFACTURING LLC•Lee, MA
•$100,000 - $160,000
About The Position
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.
Requirements
- Minimum of eight (8) to ten (10) years of experience in management
- 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
- Exceptional computer skills including Microsoft Office
- Ability to see the "Big Picture" AND demonstrate the necessary "Detail Orientation"
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
- Support process development activities
- 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
- 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
- Train and perform management of Validation Engineers and Validation Technicians
- Develop policies and systems related to validation, calibration, and preventive maintenance
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
Upload and Match Resume
What This Job Offers
Job Type
Full-time
Career Level
Manager
