Manufacturing, Training and Compliance Lead
EyePoint
Primary responsibilities include, but are not limited to:
Training Execution & Coordination
- On-the-Job Training (OJT): Coordinate and deliver technical on-the-job training and onboarding for manufacturing technicians and operators.
- LMS Administration: Manage the siteβs Learning Management System (LMS) to assign courses, log completions, and generate qualification reports.
- Competency Assessment: Conduct routine performance evaluations and practical exams to certify that operators can safely and accurately run production equipment.
Compliance Tracking & Audit Readiness
- Curriculum Compliance: Monitor team training matrices daily to ensure no operator performs a task without active qualifications.
- SOP & Documentation Review: Assist in writing, revising, and reviewing Standard Operating Procedures (SOPs), training logs, and logbooks to ensure they match current shop-floor practices.
- Audit Support: Act as the primary point of contact for training documentation during regulatory inspections to retrieve employee records.
Deviation & CAPA Support
- Root Cause Analysis: Investigate manufacturing deviations linked to human error or lack of training with Quality and Operations.
- Preventive Actions: Design and implement training interventions as part of CAPAs to prevent recurrence.
Required skills & knowledge
- Translate complex regulatory requirements and data trends into actionable manufacturing workflows.
- Experience with inspection readiness initiatives, including involvement with PAI inspections.
- Exceptional verbal and written communication skills for cross-functional influence and executive-level data presentation.
- Track record of systematically resolving operational and compliance root causes.
- Work in fast-paced environments managing multiple priorities; self-motivated with strong organization, communication, critical thinking, attention to detail, and independent/team effectiveness; flexible with shifting priorities.
Required education & experience
- Bachelorβs degree in Engineering, Life Sciences, or related technical field (or equivalent education plus hands-on manufacturing experience).
- Minimum 5 years in highly regulated manufacturing (Pharmaceutical, Biotech, Medical Device, or Aerospace), including at least 2 years in dedicated training, compliance, or coordinator capacity.
Compensation
- Salary Range: $94,760 USD - $119,480 USD