Director of Engineering, GMP Facilities & Validation

RoslinCT US

Hopkinton (MA)

On-site

USD 180,000 - 240,000

Full time

3 days ago

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Job summary

RoslinCT is seeking a Director of Engineering in Hopkinton, MA to lead the multidisciplin’d team responsible for maintaining facilities, systems, and validation activities in a GMP environment. You will drive process engineering, metrology, and capital planning while partnering with Manufacturing, Quality, and R&D to ensure compliant, cost-effective operations.

The role demands 10+ years in life sciences with a strong record of engineering leadership, and excellence in technical writing and

Qualifications

Bachelor's degree in engineering/science; 10+ years in life sciences GMP.
Experience managing multidiscipline teams in large organizations.
Strong technical writing and verbal communication skills.
Ability to investigate/troubleshoot system/testing failures.
Ability to read/interpret engineering drawings (P&IDs, PFDs).
Proficiency with Microsoft Office (Word, Excel, PowerPoint, Project).

Responsibilities

Oversee Facility, Systems, Equipment and Computerized System Validation, Process Engineering and Metrology.
Manage, coach and mentor team; conduct mid-year and annual performance reviews.
Support planning and execution of Annual Facility Shutdowns and modifications.
Develop schedule, budget, resource plans to meet site objectives.
Develop Annual opex and capital budget plans.
Collaborate with Manufacturing, PD, QC, MS&T, and Quality Assurance.
Act as SME during audits and inspections; manage deviations, CAPA, and change control.