Manufacturing Associate

Manufacturing Associate 

Reports to Manufacturing Manager

Position Summary:

Responsible for supporting the production, assembly, packaging, and inspection of combination products in a GMP-regulated manufacturing environment onsite at EyePoint’s Northbridge Facility. This role performs manufacturing operations in accordance with approved procedures, work instructions, quality requirements, and safety standards. The Manufacturing Associate I plays a critical role in ensuring products are manufactured consistently and compliantly while maintaining high standards of quality and documentation.

Responsibilities:

• Perform manufacturing, assembly, labeling, packaging, and inspection operations in a GMP environment.
• Follow approved Standard Operating Procedures (SOPs), batch records, work instructions, and production schedules.
• Complete GMP documentation accurately and contemporaneously in compliance with Good Documentation Practices (GDP).
• Assist with material handling activities, including staging, issuing, and reconciliation of in-process materials and finished goods.
• Conduct in-process inspections and quality checks to ensure product conformity.
• Maintain cleanroom and production areas in accordance with GMP and company policies.
• Perform line clearances, room setup, and product/room changeovers as required.
• Identify and report quality, safety, equipment, or process issues to supervisors.
• Support investigations, deviations, corrective actions, and continuous improvement activities.
• Participate in equipment cleaning and routine maintenance activities.
• Comply with all company safety policies, GMP regulations, and training requirements.
• Work collaboratively with Quality, Engineering, Supply Chain, and other departments to support production goals.

Required Skills/Knowledge:

• Basic understanding of GMP and quality system requirements.
• Ability to follow detailed written procedures and instructions.
• Strong attention to detail and documentation accuracy.
• Good organizational and time management skills.
• Basic computer proficiency, including Microsoft Office applications.
• Ability to work independently and as part of a team.
• Effective verbal and written communication skills.
• Willingness to learn new manufacturing processes and technologies.
• Ability to lift up to 25lbs.
• Ability to wear personal protective equipment (PPE), including cleanroom gowning
• Ability to stand, walk, bend, reach, and perform repetitive motions for extended periods.
• This position requires an eye exam

Experience:

• 0–2 years of manufacturing experience preferred.
• Experience in medical device, pharmaceutical, biotechnology, or combination product manufacturing is a plus.
• Experience working in a regulated environment preferred.

Education:

• High School Diploma or GED required.
• Associate degree, technical certification, or coursework in manufacturing, engineering, life sciences, or a related discipline preferred.