25 days old

Head of Digital Systems

Shire Human Genetic Therapies, Inc.
Lexington, MA 02421
  • Job Code
    R0033694

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Job Description

Primary Duties:

  • The Head of Digital Systems will lead the Automation Group for Lexington, Alewife, North Reading and Belmont, including all FTEs and contract personnel. The Automation Group consists of the Automation and Instrumentation & Controls Teams.
  • Lead the Automation Engineering function supporting mission critical Automation Systems in the manufacturing of commercial and clinical products at multiple Takeda sites. The scope of this group will include support of the following systems:
    • SCADA and PLC systems
    • Process Automation and Building Management Systems
    • Central Monitoring Systems
    • Data Historians
  • Lead and manage the group of automation engineers and represent the Automation Engineering function to other partner groups such as IT, Quality, Validation; Manufacturing, Facilities, Global Engineering and Global Automation, ensuring the quality of work and appropriate resources are in place to support ongoing iniatives, operations and projects requiring Automation Engineering Support
  • Support Manufacturing and Operations by providing strategic direction and tactical support. Troubleshoot day-to-day issues, assigning personnel as necessary to provide comprehensive solutions.

Responsibilities:

  • Lead a group of managers, engineers, technical specialists and instrument technicians in support of clinical and commercial drug substance and drug product operations
  • As a key member of the MA Bio Ops Facilities & Engineering Leadership Team, the Head of Automation is responsible for leading the successful execution of automation activities in support of manufacturing operations in a highly automated manufacturing facility. Ensures that all activities are performed with 100% compliance to cGMP documentation standards. Drive continuous improvement projects and ensure full support of the automation portion of cross-functional capital projects.
  • The Head of Automation is responsible for developing and implementing an innovative and compelling vision and strategy for the future of the Automation Group, including Manufacturing Intelligence and Digitization in order to meet the sites objectives. Responsible for implementation of strategic initiatives by developing plans with feedback from key stakeholders and leading the team through the execution plans. Drive strategic initiatives to ensure that life cycle management of automated systems is appropriate and complete.
  • Assist and provide resources in various stages of the engineering project lifecycle from conceptual design, detailed design, specification, implementation, commissioning, qualification, trouble-shooting and continuous improvement of automation and instrumentation for biopharmaceutical production and supporting utility systems
  • Liaise between Manufacturing and Facility clients and external engineering and vendor resources in the conceptual design, detailed design, specification, procurement, construction, commissioning and qualification of automation systems for cGMP production facilities.
  • Collaborate with functional and discipline heads and leads to develop solutions to issues that are immediately impacting business needs. Collaborates effectively with Operations, Quality, Regulatory, Process Development, Supply Chain, and other key groups involved in GMP manufacturing. Interfaces effectively with other leaders within the Global Automation network.
  • Forecasts and adheres to departmental budget, and responsibly manages cost center resource.

Education and Experience Requirements:

  • BS or advanced degree in Engineering or Life Science with at least 12 years of relevant experience, with appropriate industrial controls experience
  • A minimum of 7 years in a management role, with progressive responsibility
  • Proven leadership skills for leading an Automation Group in a Biotech facility
  • Proven record of technical leadership, including the ability to influence, motivate, and drive technical rigor
  • Proven record of management, including the ability to juggle multiple priorities, maximize staff effectiveness, and allocate resources in a dynamic environment
  • Excellent communication skills to be able to communicate with key personnel and stakeholders at all levels of the organization
  • Good understanding of control system philosophy, control system standards, instrumentation configuration, programming, and design in a cGMP environment
  • Knowledge of systems such as Allen Bradley PLC platforms, Schneider Electric, Johnson Controls, Amega or DeltaV, SCADA systems, PI Historian, Siemens PLC S7, iFix, iHistorian, Industrial Ethernet networks, Profibus and AS-I networks
  • Knowledge and understanding of Data Integrity and how it applies to the BioTech Industry with specific focus on guidelines from the FDA and EMA
  • Exposure to batch and continuous processes found in the pharmaceutical and Biotech Industries is preferred
  • Experience with S88 and ASTM 2500 principals would be an advantage

Key Skills, Abilities, and Competencies:

  • Good organizational and teamwork skills are required to be successful in this dynamic environment with changing priorities
  • Good verbal and written communication skills required to present and document initiatives and strategic direction for projects, control system project proposals, change management, system specifications and other technical requirements
  • Familiarity working in a cGMP environment to ensure compliance with company policies and procedures
  • Knowledge of current trends in automation and instrumentation technology so as to be able to provide direction to new technologies and modern controls architectures
  • Ability to provide technical support for complex capital projects within the pharmaceutical industry in accordance with domestic and international cGMP regulations
  • Ability to develop options assessments and suggest recommended best actions based on data
  • Maintain continuous awareness around cGMP and quality; adheres to compliance requirements
  • Ability to apply the traditional engineering project stages from origination through closure and rely on thorough options analysis to make data-driven recommendations
  • Establishes rapport and build relationships that create networks with those individuals and stakeholder groups critical to short and long term strategic attainment
  • Performs consistently every day and pursues all activities with energy, drive, and a true sense of urgency and ownership to deliver results
  • Proficiency with Microsoft products and the desire to learn additional software applications as required

Complexity and Problem Solving:

  • Ability to objectively analyze data and align expectations to bring definition to projects that have loosely defined objectives
  • Ability to diagnose and solve complex automation problems to support 24/7 manufacturing activities
  • Ability to work across functions and disciplines to ensure full support and alignment to improve the compliance and efficiency of manufacturing activities
  • Ability to manage and direct a group of technically based engineers and build a relationship of trust and respect that will allow for cohesive troubleshooting and project execution and supporting multiple functions and disciplines within the organization
  • Good understanding of industry standards and practices related to controls software design and commissioning

Internal and External Contacts:

  • Internal: Plant Engineering, Process Engineering, Facilities and Engineering, Quality, Validation and Manufacturing
  • External: Control System Platform Vendors; Systems Integrators; Consultants

Other Job Requirements:

  • The ability to work at all MABioOPs Takeda Facilities (Lexington, Alewife, North Reading, Belmont, Cambridge)
  • The candidate will be expected to evaluate and prioritize activities to support the business and add value to the company while understanding the specific priorities at the multiple sites
  • Candidate will be required to carry a cellular device and be available to support production requirements at all sites
  • Travel (domestic and/or international) may be required, but should not exceed 10%

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs

Empowering Our People to Shine

Discover more at takedajobs.com

No Phone Calls or Recruiters Please.

Location and Salary Information:

This job posting excludes CO applicants.

Locations

USA - MA - Lexington - BIO OPS

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time





Posted: 2021-03-26 Expires: 2021-04-24
Sponsored by:
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Sponsored by:
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Head of Digital Systems

Shire Human Genetic Therapies, Inc.
Lexington, MA 02421

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