Senior Director, Site Engineering

15 hours ago

Devens, United States ECLARO Full time

Position Summary

The Sr. Director, Cell Therapy Devens Manufacturing Site IT Lead position plays a critical role in managing all corporate & locally supported infrastructure and software at the Devens, MA Cell Therapy manufacturing site. We are seeking a highly skilled and experienced IT Platform and Product Manager to oversee the IT operations at our manufacturing site. The ideal candidate will be responsible for designing, managing IT platforms, ensuring seamless integration and functionality, and driving product development initiatives. This role requires a strong understanding of manufacturing processes, IT infrastructure, and the ability to collaborate with cross-functional teams to deliver innovative solutions. The role must excel at supporting the site’s daily operations while also developing a strategic IT roadmap for the site. This role will work closely with executive leadership and other key stakeholders to support the organization's growth and success.


This role will report to the Executive Director, Digital/IT - Cell Therapy Manufacturing Operations and will also be part of CTGM IT Leadership Team.


DUTIES AND RESPONSIBILITIES:

  • Lead a matrixed organization composed of both site direct reports and groups of indirect reports to deliver effective, innovative and stable solutions that meet the needs of the site. Lead, mentor, and develop a high-performing IT team, fostering a culture of innovation, collaboration, and continuous improvement.
  • Active member of the Cell Therapy Site Leadership Team (SLT). Collaborate with site leadership to develop, support, and align strategies for business process improvements through information systems automation.
  • Function as the liaison and the single point of contact between site leadership and corporate IT.
  • IT Platform Management:
  1. Oversee the development, implementation, and maintenance of IT platforms to support manufacturing operations.
  2. Ensure the integration and compatibility of various IT systems and platforms.
  3. Monitor and optimize platform performance, reliability, and security.
  • Product Management:
  1. Lead the product development lifecycle, from concept to launch, for IT solutions supporting manufacturing operations.
  2. Collaborate with stakeholders to define product requirements, prioritize features, and create product roadmaps.
  3. Conduct market research and competitive analysis to identify opportunities for innovation and improvement.
  • Project Management:
  1. Plan, execute, and manage IT projects, ensuring they are delivered on time, within scope, and within budget.
  2. Identify and mitigate project risks and resolve issues as they arise.
  3. Track project progress and report on key performance indicators (KPIs).
  • Develop and implement comprehensive IT strategies that support the organization's business objectives and growth plans. Ensure the IT applications can support the current and the expected future patient capacity.
  • Oversee the development and management of the IT budget, ensuring alignment with financial goals.
  • Accountable for continuous operation, maintenance and improvement of process automation systems, MES, LIMS, application integrations, local manufacturing, quality control and quality management site IT systems as well as associated site infrastructure.
  • Lead Cell Therapy site service level management scope and process with IT groups and/or vendor managed services, i.e. Service Level Agreements (SLA’s), Disaster Recovery/Service Continuity, etc.
  • Provide IT leadership to site regulatory inspection readiness and data integrity initiatives.
  • Participate in high-level strategic communications with the business and site leadership teams.
  • Ensure the reliability, security, and scalability of the organization's IT infrastructure, including networks, servers, and storage systems. Oversee the implementation and maintenance of disaster recovery and business continuity plans.
  • Manage new demand from the various site functions (Manufacturing Operations, Quality, Supply Chain, Manufacturing Science & Technology) through the IT stage gate process.
  • Identify key technology trends and how new technologies might be leveraged to provide better solutions to the manufacturing site.
  • Negotiate and manage contracts with IT vendors, service providers, and consultants.


Qualifications & Experience

  • Bachelor's degree in an Information Technology, life sciences or engineering discipline (Master’s Degree preferred) or a minimum of 12 years of equivalent biotechnology or pharmaceutical industry experience.
  • Proven experience in IT platform management, product management, and manufacturing site IT operations.
  • Extensive experience in a senior IT leadership role, with a proven track record of successful IT strategy development and execution preferably within a pharmaceutical technical operations environment. Experience should range from manufacturing and quality control systems to GxP quality management systems.
  • Demonstrated Strong leadership and team management skills, with the ability to inspire and motivate a diverse team.
  • Excellent project management skills, with the ability to manage multiple projects simultaneously.
  • Strong analytical and problem-solving skills.
  • In-depth knowledge of IT infrastructure systems, change management, staff mentoring, performance evaluation, life-long learning, and diagnosis of sources of problems in both technology and business processes.
  • Deep knowledge of regulatory requirements in the areas of current Good Manufacturing Process (cGMP).
  • Understanding of regulatory requirements and the role technology plays in satisfying those requirements is essential to this position.
  • Thorough understanding of best practices in SDLC and ITIL.
  • Effective communication and interpersonal skills, with the ability to influence and engage stakeholders at all levels. Must be client service-driven with excellent relationship management and analytical skills.
  • MES, Automation, IT Quality & Compliance, Enterprise System Integrations, IT infrastructure and IT Lab Systems experience preferred.

  • Senior Director, Devens Digital Plant and Site IT Lead

    5 hours ago

    Devens, United States Bristol-Myers Squibb Full time

    Working with UsChallenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...

  • Senior Software Engineer

    10 minutes ago

    Devens, United States ZipRecruiter Full time

    Job DescriptionJob DescriptionSalary: About us VulcanForms builds and operates advanced digital infrastructure enabling the world's critical industries to innovate, grow, and deliver sustainable impact. Founded in 2015, VulcanForms invented and commercialized the world's first industrially scalable laser metal additive manufacturing (AM) solution and...

  • Senior Software Engineer

    21 hours ago

    Devens, United States VulcanForms Full time

    Job DescriptionJob DescriptionSalary: About usVulcanForms builds and operates advanced digital infrastructure enabling the world's critical industries to innovate, grow, and deliver sustainable impact. Founded in 2015, VulcanForms invented and commercialized the world's first industrially scalable laser metal additive manufacturing (AM) solution and...

  • Senior Production Readiness Engineer

    21 hours ago

    Devens, United States VulcanForms Inc. Full time

    About us VulcanForms builds and operates advanced digital infrastructure enabling the world's critical industries to innovate, grow, and deliver sustainable impact. Founded in 2015, VulcanForms invented and commercialized the world's first industrially scalable laser metal additive manufacturing (AM) solution and pioneered integrated digital production...

  • Senior Associate Engineer 1

    12 hours ago

    Devens, United States Futran Tech Solutions Pvt. Ltd. Full time

    Location: Devens, MA (Hybrid) experience supporting Biologics Drug Substance manufacturing processes Responsibilities: • Responsible for supporting commercial manufacturing performance at the external manufacturing site. Represents MS&T external manufacturing team to provide person in plant technical support to the commercial manufacturing process...

  • EHS Senior Specialist

    18 hours ago

    Devens, United States ASK Consulting LLC Full time

    "All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment". Job Title: EHS Senior Specialist Location: Devens, MA Duration: 12 months Pay rate: $74.82/ hr on W2 Job Description: This position is responsible for supporting the administration of various EHS...

  • EHS Senior Specialist

    5 days ago

    Devens, United States ASK Consulting Full time

    "All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment".Job Title: EHS Senior SpecialistLocation: Devens, MADuration: 12 monthsPay rate: $74.82/ hr on W2Job Description:This position is responsible for supporting the administration of various EHS programs...

  • EHS Senior Specialist

    5 days ago

    Devens, United States ASK Consulting Full time

    "All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment".Job Title: EHS Senior SpecialistLocation: Devens, MADuration: 12 monthsPay rate: $74.82/ hr on W2Job Description:This position is responsible for supporting the administration of various EHS programs...

  • Senior Commissioning Engineer

    1 day ago

    Devens, Massachusetts, United States Bristol-Myers Squibb Full time

    About the RoleAt Bristol-Myers Squibb, we are seeking a highly skilled Commissioning Engineer I to join our team. As a key member of our Commissioning team, you will be responsible for ensuring the smooth execution of capital projects and leading installation, commissioning activities of area-specific process equipment.Key Responsibilities- Execute and/or...

  • Director of Sourcing and Supply Chain

    3 days ago

    Devens, Massachusetts, United States Bristol-Myers Squibb Full time

    Drive Business Growth with Strategic ProcurementBristol Myers Squibb is a global leader in the pharmaceutical industry, and we are seeking a talented and experienced procurement professional to join our team as a Director of Sourcing and Supply Chain. In this critical role, you will be responsible for developing and implementing procurement strategies that...

  • Procurement Director for Engineering and Construction

    3 days ago

    Devens, Massachusetts, United States Bristol-Myers Squibb Full time

    Ambitious Procurement Professional WantedWe are a leading global pharmaceutical company looking for a skilled and ambitious procurement professional to lead our engineering and construction procurement efforts. If you have a passion for procurement and a proven track record of delivering results, we want to hear from you!The successful candidate will be...

  • Specialist, Commissioning Engineer I

    19 hours ago

    Devens, United States Bristol-Myers Squibb Full time

    Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...

  • Industrial Automation Engineer

    5 days ago

    Devens, Massachusetts, United States Veranova Full time

    About the RoleWe are seeking a highly skilled Industrial Automation Engineer to join our team at Veranova. In this role, you will be responsible for the design, development, and implementation of automation and control systems across our New England sites.The ideal candidate will have experience in diagnosing issues and replacing components in low-voltage...

  • Chief Engineer

    53 minutes ago

    Devens, United States Commonwealth Fusion Systems Full time

    Devens, MASPARC Balance of Plant – Construction /Full-time /HybridAbout Commonwealth Fusion Systems: Commonwealth Fusion Systems is on a mission to deliver the urgent transition to fusion energy.Combining decades of research, top talent and new technologies, we’re designing and building commercially viable fusion power plants. And working with...

  • Senior Validation Specialist

    2 days ago

    Devens, Massachusetts, United States National Guard Employment Network Full time

    At National Guard Employment Network, we're committed to empowering our employees with the tools and resources they need to succeed. As a Senior Validation Specialist, you'll play a critical role in ensuring the quality and integrity of our manufacturing processes.">About UsWe're a dynamic organization dedicated to providing exceptional employment...

  • Chief Additive Manufacturing Engineer

    5 days ago

    Devens, Massachusetts, United States VulcanForms Full time

    At VulcanForms, we are seeking a highly skilled Senior Engineer, Process Development to join our team of leading technology and operational experts. As a key member of our process development team, you will be responsible for designing, developing, optimizing, and implementing high-speed laser powder-bed fusion processes for industrial applications.You will...

  • Senior Quality Control Professional

    6 days ago

    Devens, Massachusetts, United States Bristol-Myers Squibb Full time

    Are you looking for a career that offers uniquely interesting work and life-changing opportunities? Look no further than Bristol-Myers Squibb. As a QC Operations Senior Associate, you will have the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity.Our company culture is built on a...

  • Senior Research and Development Leader

    4 days ago

    Devens, Massachusetts, United States Veranova L P Full time

    About the Role:We are seeking an exceptional Senior Research and Development Leader to join our team at Veranova LP. As the Senior R&D Leader, you will be responsible for leading the analytical research and development function by providing strategic direction and management of resources. Your primary focus will be on cultivating a world-class analytical...

  • Senior Environmental and Safety Professional

    5 days ago

    Devens, Massachusetts, United States ASK Consulting Full time

    We are seeking a highly skilled Senior Environmental and Safety Professional to join our team at ASK Consulting. This role will be responsible for supporting the administration of various EHS programs and initiatives, ensuring compliance with federal, state, and local laws and regulations.Key Responsibilities:Compliance Management: Ensure that all operations...

  • Battery Applications Engineer

    6 days ago

    Devens, United States Mackinnon & Partners Full time

    We are looking for a knowledgeable and driven Battery Applications Engineer to design and optimize battery systems for a variety of applications, including energy storage, electric vehicles, and industrial power systems. This role involves system design, performance analysis, and technical support, ensuring reliable and efficient battery integration with...