Director of Engineering, GMP Facilities & Validation

RoslinCT; Hopkinton (MA); On-site; USD 180,000 - 260,000; Full time

Job summary

RoslinCT is seeking a Director of Engineering in Hopkinton, MA to lead a multidisciplinary team ensuring GMP manufacturing readiness and continuous process improvements. You will manage facility, systems, equipment and validation activities while partnering with QA, PD, QC and manufacturing leaders to maintain regulatory compliance and operational excellence.

The role requires a strong background in life sciences engineering, hands-on leadership, and a track record of delivering cost-effective

Qualifications

• Bachelor's degree in engineering or life sciences required.
• 10+ years of experience in life sciences manufacturing and team leadership preferred.
• Excellent technical writing and verbal communication skills.

Responsibilities

• Oversee Facility, Systems, Equipment and Computerized System Validation, Process Engineering and Metrology for Hopkinton site.
• Lead, coach and mentor a multidisciplined engineering team; conduct performance reviews.
• Plan annual facility shutdowns, modifications, schedules and budgets.
• Collaborate with site leadership and cross-functional groups to ensure GMP/HSE compliance and cost control.
• Manage deviations, CAPAs, investigations and change controls as required.

Skills

Leadership

GMP

Troubleshooting

Technical writing

Communication

Education

Bachelor's degree in engineering or life sciences

Tools

Microsoft Office

Job description

RoslinCT is seeking a Director of Engineering in Hopkinton, MA to lead a multidisciplinary team ensuring GMP manufacturing readiness and continuous process improvements. You will manage facility, systems, equipment and validation activities while partnering with QA, PD, QC and manufacturing leaders to maintain regulatory compliance and operational excellence.

The role requires a strong background in life sciences engineering, hands-on leadership, and a track record of delivering cost-effective