Manufacturing Associate II
EyePoint
August 19, 2026
On-site
Worcester, MA
Operations
Responsibilities:
- Perform manufacturing, assembly, labeling, packaging, and inspection activities per approved procedures and production schedules.
- Independently execute manufacturing operations in 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.
- Perform line clearances, room preparation, product changeovers, and equipment setup.
- Assist with material handling (staging, issuing, 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, CAPAs, and root cause analyses.
- Participate in process validation, equipment qualification, and manufacturing engineering activities as required.
- Train/mentor junior personnel.
- Support continuous improvement for quality, efficiency, productivity, and compliance.
- Collaborate with QA, QC, Engineering, Supply Chain, and other teams.
- Maintain production areas and equipment in inspection-ready condition.
- Comply with company safety policies, GMP regulations, and training requirements.
Required/Preferred Skills & Qualifications:
- Working knowledge of cGMP, GDP, and quality system requirements.
- Proficiency in manufacturing documentation and batch record execution.
- Ability to operate/troubleshoot manufacturing and packaging equipment.
- Attention to detail; commitment to product quality.
- Organizational and problem-solving skills; strong verbal/written communication.
- Basic proficiency with electronic quality management systems (preferred).
- Ability to train others; work independently with limited supervision.
- Lift up to 25 lbs; wear required PPE including cleanroom gowning.
- Ability to stand, walk, bend, reach, and perform repetitive motions for extended periods; requires an eye exam.
- Experience: 2–5 years in a regulated manufacturing environment; medical device/pharma/biotech/combination product manufacturing (required). GMP equipment operation/documentation (preferred).
- Education: High School Diploma or GED required; associate degree/technical certification/coursework in related fields (preferred).
- Perform manufacturing, assembly, labeling, packaging, and inspection activities per approved procedures and production schedules.
- Independently execute manufacturing operations in 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.
- Perform line clearances, room preparation, product changeovers, and equipment setup.
- Assist with material handling (staging, issuing, 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, CAPAs, and root cause analyses.
- Participate in process validation, equipment qualification, and manufacturing engineering activities as required.
- Train/mentor junior personnel.
- Support continuous improvement for quality, efficiency, productivity, and compliance.
- Collaborate with QA, QC, Engineering, Supply Chain, and other teams.
- Maintain production areas and equipment in inspection-ready condition.
- Comply with company safety policies, GMP regulations, and training requirements.
Required/Preferred Skills & Qualifications:
- Working knowledge of cGMP, GDP, and quality system requirements.
- Proficiency in manufacturing documentation and batch record execution.
- Ability to operate/troubleshoot manufacturing and packaging equipment.
- Attention to detail; commitment to product quality.
- Organizational and problem-solving skills; strong verbal/written communication.
- Basic proficiency with electronic quality management systems (preferred).
- Ability to train others; work independently with limited supervision.
- Lift up to 25 lbs; wear required PPE including cleanroom gowning.
- Ability to stand, walk, bend, reach, and perform repetitive motions for extended periods; requires an eye exam.
- Experience: 2–5 years in a regulated manufacturing environment; medical device/pharma/biotech/combination product manufacturing (required). GMP equipment operation/documentation (preferred).
- Education: High School Diploma or GED required; associate degree/technical certification/coursework in related fields (preferred).