Manufacturing Associate I-2nd Shift-Bulk

Alkermes • Wilmington, OH

401d

About The Position

The Manufacturing Associate I position is responsible for performing various operational activities in bulk manufacturing, including equipment cleaning, set-up, operation, and batch processing. The role requires adherence to detailed written SOPs and cGMP documentation, along with responsibilities such as sample collection, equipment monitoring, and minor maintenance. The associate must maintain training proficiency and may assist with development activities and validation as required.

Requirements

• High school diploma or equivalent required.
• General math skills, including simple algebra.
• Knowledge of Current Good Manufacturing Practices (cGMP).
• Familiarity with HAZCOM, RCRA, and other safety requirements.
• Good mechanical aptitude for minor equipment adjustments.
• Proficient in general computer word processing and spreadsheet skills.
• Excellent written communication and documentation skills.
• Ability to gown in an aseptic manner for clean room operations.
• Ability to lift/move up to 50 lbs and team lift up to 100 lbs.

Nice To Haves

• 0-1 year experience in a sterile pharmaceutical operation preferred.
• Associate degree or higher in a science/technical discipline preferred.
• 1+ year experience in a sterile pharmaceutical operation for Manufacturing Associate II.
• 2-3 years experience in a sterile pharmaceutical operation for Manufacturing Associate III.

Responsibilities

• Perform equipment cleaning and set-up for manufacturing processes.
• Operate equipment and automation for batch processing.
• Document all work in compliance with cGMPs in a timely manner.
• Monitor processes with close attention to detail.
• Follow safety requirements as defined by the company.
• Work independently without constant supervision.
• Collaborate effectively in a team environment.
• Assist with development activities and validation as required.
• Write and review SOPs and cGMP documentation as needed.

Benefits

• Health insurance coverage.
• 401k retirement savings plan.
• Paid holidays and vacation time.
• Opportunities for professional development and training.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Chemical Manufacturing
• Education Level: High school or GED