Senior/Facilities Engineer
EyePoint
1 month ago
On-site
Watertown, MA
$124,630 - $179,220 USD yearly
Operations
Responsibilities:
- Lead engineering aspects of projects through all phases, including design, equipment procurement, construction, installation, startup, commissioning, qualification, and validation.
- Lead or collaborate on project planning and implementation to reduce operating costs and increase efficiency.
- Own and complete complex projects to implement new manufacturing and utility equipment supporting new manufacturing processes and improving operational efficiency.
- Maintain Engineering Turnover Packages (specifications, component lists, operating manuals, drawings) for GMP equipment; update as required.
- Coordinate and communicate engineering activities with equipment vendors and internal stakeholders.
- Provide direct engineering support and subject matter expertise for process and utility equipment across EyePoint facilities as needed.
- Write and execute project execution plans, test protocols, validation protocols, and final reports.
- Work in cross-functional teams to coordinate equipment implementation and operational improvements.
- Support Facilities Operations with troubleshooting, maintenance plan/activity review, SOP review/revision, and efficiency improvements within Facilities and Engineering.
Qualifications (Required/Primary):
- Experience in life sciences, medical devices, or regulated industry.
- Exceptional project management skills; ability to track/manage complex processes, projects, and budgets.
- Analytical skills to analyze process steps and pursue optimization.
- Mechanical skills to oversee production equipment.
- Experience commissioning and qualifying equipment and utilities in a GMP facility.
- Familiarity with engineering software such as Bluebeam, AutoCAD, and/or SOLIDWORKS.
- Experience managing Quality Systems (Deviations, Change Controls, CAPA).
Other Requirements:
- Proactive, creative problem solver; highly organized and detail oriented.
- Excellent written and verbal communication and listening skills.
- Adaptability and resiliency; ability to thrive in a fast-paced organization.
- Ability to influence and drive organizational success.
- Track record of successful cross-functional leadership, collaboration, and relationship building.
Education:
- Bachelor of Science (preferably Chemical or Mechanical Engineering).
Experience:
- Minimum 5–8 years in the medical device and/or pharmaceuticals industry.
- Lead engineering aspects of projects through all phases, including design, equipment procurement, construction, installation, startup, commissioning, qualification, and validation.
- Lead or collaborate on project planning and implementation to reduce operating costs and increase efficiency.
- Own and complete complex projects to implement new manufacturing and utility equipment supporting new manufacturing processes and improving operational efficiency.
- Maintain Engineering Turnover Packages (specifications, component lists, operating manuals, drawings) for GMP equipment; update as required.
- Coordinate and communicate engineering activities with equipment vendors and internal stakeholders.
- Provide direct engineering support and subject matter expertise for process and utility equipment across EyePoint facilities as needed.
- Write and execute project execution plans, test protocols, validation protocols, and final reports.
- Work in cross-functional teams to coordinate equipment implementation and operational improvements.
- Support Facilities Operations with troubleshooting, maintenance plan/activity review, SOP review/revision, and efficiency improvements within Facilities and Engineering.
Qualifications (Required/Primary):
- Experience in life sciences, medical devices, or regulated industry.
- Exceptional project management skills; ability to track/manage complex processes, projects, and budgets.
- Analytical skills to analyze process steps and pursue optimization.
- Mechanical skills to oversee production equipment.
- Experience commissioning and qualifying equipment and utilities in a GMP facility.
- Familiarity with engineering software such as Bluebeam, AutoCAD, and/or SOLIDWORKS.
- Experience managing Quality Systems (Deviations, Change Controls, CAPA).
Other Requirements:
- Proactive, creative problem solver; highly organized and detail oriented.
- Excellent written and verbal communication and listening skills.
- Adaptability and resiliency; ability to thrive in a fast-paced organization.
- Ability to influence and drive organizational success.
- Track record of successful cross-functional leadership, collaboration, and relationship building.
Education:
- Bachelor of Science (preferably Chemical or Mechanical Engineering).
Experience:
- Minimum 5–8 years in the medical device and/or pharmaceuticals industry.