Manufacturing Specialist (Cleanroom Lead)

Role Summary

The manufacturing specialist will work with the production teams to manufacture product and ensure each batch is manufactured safely and in compliance with the batch instructions and quality requirements. As a subject matter expert for product and process knowledge, the specialist role will be the on the floor lead for product and process related issues. This position requires experience with cGMP manufacturing. Excellent hand/eye coordination required for the handling & related process operations required for manufacture of small ophthalmic inserts. The manufacturing specialist role will report directly to the Manufacturing Manager.

Responsibilities

• Perform and lead manufacturing activities in controlled classified ISO 7 cleanrooms adhering to current good manufacturing practices (GMP’s), 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 “speak up” 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 SOP’s.
• 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.