Job Title: Sr. Manufacturing Tech, 2nd shift

Work Location: Middlesex County, Massachusetts

Summary:

The Sr. Manufacturing Tech, 2nd shift is responsible for executing procedures and activities related to the production of cross linked hyaluronic acid products. This role follows established protocols and receives guidance on new tasks, ensuring compliance with industry standards and documentation practices.

Responsibilities:

• Operate production equipment in accordance with established procedures, including SOPs, Batch Records, and Manufacturing Directions.
• Carry out all steps involved in the production of cross linked hyaluronic acid products, ensuring adherence to process requirements.
• Follow detailed instructions for solvent recovery and cleaning of complex equipment, both in-place and out-of-place.
• Perform scheduled cleaning and sterilization of production equipment to maintain operational standards.
• Support changeover activities between production batches and assist with troubleshooting process issues.
• Accurately record data in Batch Records, log books, and other required documentation, ensuring compliance with Good Documentation Practices.
• Report any procedural deviations or nonconformance and maintain up-to-date training on all assigned procedures.
• Review logbooks and forms to ensure completeness and accuracy of documentation.

Qualifications:

• High school diploma, GED, or equivalent experience.
• 2-4 years of related experience in a cGMP manufacturing environment.
• Ability to work flexible hours as needed to complete work activities.
• Strong written and verbal communication skills.
• Capability to gown and access biotechnology/pharmaceutical manufacturing areas, and wear required personal protective equipment.
• Physical ability to lift, pull, or push equipment weighing up to 25-50 lbs, stand for extended periods (up to 6 hours), and climb ladders or work platforms.
• Comfort working around chemicals such as alcohols, acids, and bases.
• Experience in medical device manufacturing, clean room environments, or aseptic techniques is preferred.
• Familiarity with commercial scale automated equipment and ability to perform computerized transactions and maintain spreadsheets is a plus.

Published Category: Manufacturing & Technical Operations