Director of Engineering
About The Position
The Director of Engineering reports to the Senior Director of Facilities and Engineering. This position leads a multidisciplined team of Engineering staff responsible for maintaining the facility and its equipment in a state that's fit for GMP manufacturing purposes and poses no risk to health and safety. This team is responsible for Facility, Systems, Equipment and Computerized System Validation, Process Engineering and Metrology. The position collaborates with Equipment, System and Area owners to provide technical leadership to strategically and proactively manage all aspects of plant operations and modifications with a focus on HSE and GMP compliance and cost control.
Requirements
- Bachelor's degree (or equivalent) in engineering/science and 10+ years' experience working in the life sciences industry, preferably in GMP commercial manufacturing operations.
- 10 plus years' experience managing multidisciplined direct reports in larger complex organizations.
- Excellent technical writing and verbal communication skills
- Ability to Investigation/troubleshooting system/testing failures
- Ability to read/interpret engineering drawings (e.g. P&IDs, PFD's)
- Microsoft Office includes Word, Excel, PowerPoint and Project.
Responsibilities
- Responsible for oversight of Facility, Systems, Equipment and Computerized System Validation, Process Engineering and Metrology activities for the Hopkinton facility
- Manage, coach and mentor personnel on the team; provide technical assistance and opportunities for growth; conduct mid-year and annual performance reviews
- Support planning and execution of Annual Facility Shutdowns and modifications
- Develop schedule, budget, resource plans to meet overall site objective
- Develop Annual opex and capital budget plans
- Work in a collaborative team environment and interact with site leadership and support groups such as Manufacturing, PD, QC, MS&T, and Quality Assurance.
- Act as a subject matter expert supporting site during audits and inspections as needed
- Manage assigned deviation, CAPA, and change control activities.
- Generate deviations, CAPAs, perform investigations and root cause analysis.
Benefits
- medical
- dental
- vision insurance
- educational assistance
- a 401(k) program
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What This Job Offers
Job Type
Full-time
Career Level
Director
