Manufacturing Associate II

Manufacturing & Operations at EyePoint ensures the safe, compliant, and reliable production of innovative therapies for patients with serious retinal diseases. This team oversees end-to-end manufacturing, supply chain, and facilities with a strong focus on regulatory compliance, patient safety, and product integrity. Manufacturing & Operations strivesto maintain rigorous standards and efficient processes with the goal of delivering safe, high-quality therapies to patients.

The Manufacturing Associate II is responsible for executing manufacturing, assembly, packaging, inspection, and related production activities for combination products in a GMP-regulated environment. This role requires demonstrated proficiency in manufacturing operations, GMP documentation, and equipment operation. The Manufacturing Associate II serves as a fully trained operator who can work with minimal supervision, support process improvements, assist with training of junior associates, and contribute to achieving production, quality, and compliance objectives.

Responsibilities:

• Perform manufacturing, assembly, labeling, packaging, and inspection, activities in accordance with approved procedures and production schedules.
• Independently execute manufacturing operations while ensuring compliance with GMP, GDP, and company standards.
• Complete batch records, logbooks, and other production documentation accurately and contemporaneously.
• Set up, operate, troubleshoot, and perform basic maintenance on manufacturing equipment.
• Conduct in-process inspections and verify product quality throughout manufacturing operations.
• Perform line clearances, room preparation, product changeovers, and equipment setup activities.
• Assist with material handling activities, including staging, issuing, and reconciliation of in-process materials and finished goods.
• Identify and elevate process deviations, equipment issues, quality concerns, and safety risks.
• Support deviation investigations, nonconformance activities, corrective and preventive actions (CAPAs), and root cause analyses.
• Participate in process validation, equipment qualification, and manufacturing engineering activities as required.
• Train and mentor junior personnel on procedures, equipment operation, documentation practices, and GMP expectations.
• Support continuous improvement initiatives focused on quality, efficiency, productivity, and compliance.
• Collaborate effectively with Quality Assurance, Quality Control, Engineering, Supply Chain, and other functional teams.
• Maintain production areas and equipment in a state of inspection readiness.
• Comply with all company safety policies, GMP regulations, and training requirements.

Required Skills/Knowledge:

• Working knowledge of cGMP regulations, Good Documentation Practices (GDP), and quality system requirements.
• Proficiency in manufacturing documentation and batch record execution.
• Ability to operate and troubleshoot manufacturing and packaging equipment.
• Strong attention to detail and commitment to product quality.
• Ability to identify process issues and recommend practical solutions.
• Effective organizational and problem-solving skills.
• Strong verbal and written communication skills.
• Basic proficiency with electronic quality management systems preferred.
• Ability to train others and effectively transfer knowledge.
• Demonstrated ability to work independently with limited supervision.
• 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:

• 2–5 years of experience in a regulated manufacturing environment.
• Experience in medical device, pharmaceutical, biotechnology, or combination product manufacturing required.
• Experience operating production equipment and documenting manufacturing activities in a GMP 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.

EyePoint is committed to fair andequitablecompensation practices.

The salary offer…