Manufacturing Specialist
EyePoint
August 13, 2026
On-site
Worcester, MA
Operations
Responsibilities:
- Independently perform complex manufacturing, assembly, packaging, labeling, and inspection operations.
- Serve as subject matter expert (SME) for assigned manufacturing processes, equipment, and production activities.
- Set up, operate, troubleshoot, and perform advanced adjustments on manufacturing equipment.
- Review batch records, device history records, logbooks, and production documentation for accuracy and completeness.
- Identify, investigate, and resolve manufacturing issues while ensuring compliance with approved procedures and quality requirements.
- Lead/support deviation and nonconformance investigations, root cause analyses, CAPAs, and other quality system activities.
- Support process validation, equipment qualification, engineering studies, and technology transfer.
- Develop/revise/improve manufacturing procedures, work instructions, forms, and training materials.
- Train/mentor/qualify manufacturing personnel; support onboarding and development.
- Partner with Quality, Engineering, Supply Chain, and Regulatory to support manufacturing objectives.
- Drive continuous improvement and monitor manufacturing metrics.
- Assist with capacity planning, production readiness, and scheduling.
- Maintain areas in inspection readiness; promote safety, quality, accountability, and continuous improvement.
Required Skills/Knowledge:
- Advanced cGMP, GDP, and quality system requirements; strong combination product manufacturing knowledge.
- Expertise in manufacturing documentation and batch record execution.
- Advanced troubleshooting; ability to lead investigations and identify root causes.
- Technical aptitude with manufacturing equipment/automated systems; electronic quality management systems preferred.
- Organizational/communication skills; train/mentor ability; lead projects/process improvements.
- Work independently; sound judgment.
- Lift up to 25 lbs; wear PPE/cleanroom gowning.
- Stand/walk/bend/reach/repetitive motions; requires an eye exam.
Experience:
- 5+ years in a regulated manufacturing environment.
- Medical device, pharmaceutical, biotech, or combination product manufacturing experience.
- Experience supporting investigations, process improvements, equipment troubleshooting, and training.
- Lead operator/trainer/SME experience preferred.
Education:
- High School Diploma or GED required; Associate’s/Bachelor’s in a technical field preferred.
Salary Range:
- $36.06 USD - $47.04 USD
- Independently perform complex manufacturing, assembly, packaging, labeling, and inspection operations.
- Serve as subject matter expert (SME) for assigned manufacturing processes, equipment, and production activities.
- Set up, operate, troubleshoot, and perform advanced adjustments on manufacturing equipment.
- Review batch records, device history records, logbooks, and production documentation for accuracy and completeness.
- Identify, investigate, and resolve manufacturing issues while ensuring compliance with approved procedures and quality requirements.
- Lead/support deviation and nonconformance investigations, root cause analyses, CAPAs, and other quality system activities.
- Support process validation, equipment qualification, engineering studies, and technology transfer.
- Develop/revise/improve manufacturing procedures, work instructions, forms, and training materials.
- Train/mentor/qualify manufacturing personnel; support onboarding and development.
- Partner with Quality, Engineering, Supply Chain, and Regulatory to support manufacturing objectives.
- Drive continuous improvement and monitor manufacturing metrics.
- Assist with capacity planning, production readiness, and scheduling.
- Maintain areas in inspection readiness; promote safety, quality, accountability, and continuous improvement.
Required Skills/Knowledge:
- Advanced cGMP, GDP, and quality system requirements; strong combination product manufacturing knowledge.
- Expertise in manufacturing documentation and batch record execution.
- Advanced troubleshooting; ability to lead investigations and identify root causes.
- Technical aptitude with manufacturing equipment/automated systems; electronic quality management systems preferred.
- Organizational/communication skills; train/mentor ability; lead projects/process improvements.
- Work independently; sound judgment.
- Lift up to 25 lbs; wear PPE/cleanroom gowning.
- Stand/walk/bend/reach/repetitive motions; requires an eye exam.
Experience:
- 5+ years in a regulated manufacturing environment.
- Medical device, pharmaceutical, biotech, or combination product manufacturing experience.
- Experience supporting investigations, process improvements, equipment troubleshooting, and training.
- Lead operator/trainer/SME experience preferred.
Education:
- High School Diploma or GED required; Associate’s/Bachelor’s in a technical field preferred.
Salary Range:
- $36.06 USD - $47.04 USD