Manufacturing Associate II
About the role
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.
Responsibilities
- Execute manufacturing, assembly, packaging, inspection, and related production activities for combination products in a GMP-regulated environment.
- 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 escalate 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.
- Maintain production areas and equipment in a state of inspection readiness.
- Comply with all company safety policies, GMP regulations, and training requirements.
Requirements
- 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.
Qualifications
- 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.
Skills
- 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.
Benefits
EyePoint is committed to fair and equitable compensation practices. The salary offer is commensurate with EyePoint’s compensation philosophy and considers factors including but not limited to education, training, experience, market conditions, criticality of the role and internal equity. The target salary range for this position is listed below:
- Salary Range $32.21 - $41.76 USD
Pay
The salary offer is commensurate with EyePoint’s compensation philosophy and considers factors including but not limited to education, training, experience, market conditions, criticality of the role and internal equity. The target salary range for this position is listed below:
- Salary Range $32.21 - $41.76 USD
Schedule
EyePoint is committed to fair and equitable compensation practices. The salary offer is commensurate with EyePoint’s compensation philosophy and considers factors including but not limited to education, training, experience, market conditions, criticality of the role and internal equity. The target salary range for this position is listed below:
- Salary Range $32.21 - $41.76 USD