Manufacturing Specialist (Cleanroom Lead)

Role Summary

Manufacturing Specialist (Cleanroom Lead) responsible for leading manufacturing activities in ISO 7 cleanrooms, ensuring products are produced safely and in compliance with batch instructions and quality requirements. Serves as on-the-floor subject matter expert for product and process knowledge, leading related issues and ensuring cGMP compliance.

Responsibilities

• Perform and lead manufacturing activities in controlled classified ISO 7 cleanrooms adhering to current good manufacturing practices (GMP‚Äôs), governmental guidelines and company procedures.
• Maintain on-the-floor production documentation and quality records including Master Batch Records, applicable SOPs, training materials and other documentation.
• Partner with manufacturing management to schedule and plan manufacturing activities in a team environment.
• Facilitate a ‚Äúspeak up‚Äù culture to ensure all cGMP compliance activities are followed.
• Ensure processes remain inspection ready at all times.
• Support manufacturing related Deviations, Temporary Change Requests and Investigations per applicable SOPs.
• Support process efficiency and production optimization efforts.
• Ensure that work environment is maintained clean, safe and organized.
• Monitor and maintain the accuracy and movement of raw materials used in manufacturing utilizing ERP system (NetSuite).
• Initiation and closure of work orders, material requests and transfer orders.
• Monitor, maintain and assist with daily cleaning activities and logs for manufacturing areas and equipment.
• Guide and train other manufacturing associates on procedures and processes when needed.
• Work with all departments at EyePoint.
• Other tasks as assigned.

Qualifications

• Experience with production of pharmaceutical products in an ISO7 cleanroom environment including knowledge of gowning practices, cleanroom behaviors and aseptic techniques.
• Knowledge of cGMP regulations and FDA guidance applicable to drug product manufacturing.
• Previous experience working with medical device packaging and microscope assembly work.
• Strong communication skills, collaborative teammate, motivated and passionate about finding solutions.
• Strong awareness of quality issues. Compliance investigation experience preferred.
• Previous experience using semi-automated systems would be a plus.
• Ability to lift or carry up to 35 pounds.

Education

• High School Diploma or equivalent plus meet experience requirements below.

Experience

• 5-7+ years of experience working in a cGMP environment in the pharmaceutical/biopharmaceutical or medical device industry.
• 2+ years leading teams within a GMP environment.