Basic Purpose: Drives equipment implementation and upgrades within QC. Coordinate activities with plant metrology. Perform installation/qualification/validation/verification activities including writing, reviewing, and approval of protocols and reports. Assist with purchase of new instrumentation including obtaining quotes, completing CAPEX documentation, and providing budget planning regarding equipment needs. Assist with troubleshooting instrumentation issues and space planning with the QC Laboratories.

Essential Functions and Responsibilities:
• Drive all activities for validation, qualification, and implementation of new equipment and/or upgrades to existing equipment with QC to ensure timely implementation.
• Work cross functionally with Metrology, Engineering, QA, and IT.
• Perform accurate and timely review of calibration entries in ProCal.
• Communicate with QC & QA as necessary.
• Prepare, review, and/or approve engineering change controls (ECC), instrument methods, specifications, protocols, and instrument related SOPs.
• Execute IQ/OQ/PQ
• Provide coaching to groups and provide technical guidance.
• Manage outside contract personnel assisting with equipment implementation/upgrades.
• Assist with the purchase of new equipment.
• Other duties as assigned by QC Manager

Knowledge, Skills, Qualifications and Physical Requirements:

Education/Training/Work Experience:
• MS in Chemistry or related scientific field and five years of validation experience in a GMP regulated industry; BA/BS in Chemistry or related scientific field and eight years of validation experience in a GMP regulated industry.
• Demonstrate knowledge of cGMPs, Safety, OSHA, and 21 CFR regulations/requirements
• Demonstrate ability to manage projects while executing work to meet established deadlines.
• Demonstrate knowledge of technical aspects of instrument qualifications including protocol writing, execution, and troubleshooting.

Specialized Knowledge and Skills:
• Analytical/technically minded.
• Quality driven
• Proficient in technical writing
• Ability to multi-task under stress of multiple priorities
• Good oral and written communication skills
• Good organizational and people skills

Equipment and Applications:
• IR
• UV/Vis
• HPLC
• GC
• Empower Software
• Dissolution
• Karl Fischer

Work Environment and Physical Demands:
• Lab coat
• Safety glasses
• Gloves
• Ability to occasionally lift 50 pounds