Director of Engineering

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

Who We Are

RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people's lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science.

Who We Are

RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people's lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science.

THE ROSLINCT WAY

Here at RoslinCT, our team can contribute to the development of revolutionary treatments. We live every day by our core values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success. At RoslinCT we focus on developing our corporate culture, people's development, growth, and the ability to impact patients.

ACCELERATING YOUR FUTURE

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.

How You Will Make An Impact

• 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.

What You Will Bring

• 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.

Final compensation will be based on a variety of factors, including education, experience, technical expertise, specialized skill sets, market demand, internal equity, and business needs.

At RoslinCT, we offer more than just competitive pay. Our comprehensive Total Rewards package is designed to support your health, financial well-being, and professional development throughout your career. Benefits include medical, dental, and vision insurance, educational assistance, a 401(k) program, and a variety of additional resources to help you thrive both personally and professionally.

OUR COMMITMENT

All RoslinCT employees embrace the principles of our culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways.

RoslinCT is proud to be an equal opportunity employer, we seek to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.