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Takeda Pharmaceuticals Automation Lead (Director) in Lexington, Massachusetts

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Job Description

Job Title : Automation Lead (Director)

Location : Lexington, MA

About the role:

As the Automation Lead, you will empower and support staff members to ensure Automation Systems are "fit for purpose" for the manufacture of drug substance to meet Regulatory, Quality, Capacity and EHS requirements. You will drive strategic preparation of the Mass Bio Ops sites for the future by introducing new automation technologies and delivering agile automation engineering solutions. You will lead engineering disciplines during the development of projects and implement strategies to ensure cost and time effective designs adhere to user requirements while managing daily operational support. You will be an integral member of the Site Engineering Leadership Team and work in collaboration with your colleagues to drive strategic objectives that transform Site Engineering into a best-in-class organization that is fit for the future.

This is a hybrid role reporting to the Head of Site Engineering.

How you will contribute:

  • Develop a strategic workforce setup delivering the following mission-critical roles, skills and deliveries in the field of: Automation Data Engineering & Governance, Automation Cybersecurity & Data Integrity Compliance, Automation Solution & System Engineering, Automation & OT System Support. Improve existing systems to minimize the production of downtime and lead all automation system related investigations.

  • Develop core competencies of the automation SMEs building technical capabilities to develop our future leaders. Lead the automation engineering function partnering with IT, Quality, Validation, Manufacturing, Facilities, Global Engineering and Global Automation to ensure the quality of work and resource support for ongoing initiatives, operations and projects requiring Automation Support.

  • Assist with the automation teams on subject matter expert level to provide direction and oversight in several stages of the engineering project lifecycle from conceptual design, detailed design, specification, implementation, commissioning, qualification, trouble-shooting and continuous improvement of automation and control systems (process, utilities, facilities).

  • Support automation teams on the subject matter expert level and provide direction in several stages of the engineering project lifecycle from conceptual design, detailed design, specification, implementation, commissioning, qualification, trouble-shooting and continuous improvement of automation and control systems (process, utilities, facilities).

  • Drive aspects of modern automation (state-of-the art/emerging automation system technology and shop floor data integration (connectivity and communication). Ensure end to end real-time shop floor data automation and historical concepts.

  • Promote Good Engineering Practices in all projects undertaken and support services provided. Utilize standard methodologies that have been established for project and portfolio management and supporting maintenance work order management.

  • Be the Business and System Owner Function for Automation & control systems, including administrative ownership for Functional Level 0-3 systems (control systems and the data thereof).

  • Understanding of the IT4OT infrastructure (hosting and network) practices/procedures needed to keep the IT4OT infrastructure of such control systems operable and can advise IT service departments. Can define SLA requirements with internal (e.g. IT4OT infrastructure (secure hosting & network services) and external service providers (Automation system integrators and Automation Vendors and can keep traction of corresponding KPI fulfillments for the department.

  • Align the Automation Capex portfolio with the regional/Operating Unit Automation Leads and other stakeholders (like site capital planning).

  • Lead Automation originating Deviations/CAPA as a system owner for Automation & Control Systems; support Manufacturing Equipment owners as Automation subject matter expert for deviation/CAPAs of equipment embedded controls/automation. Assess, analyze, advise, propose, and direct improvements to deliver greater productivity, capacity, reliability, and compliance for the Automation Department. Ensure compliance with automation standards, guidelines, GxP compliance and automation cybersecurity.

  • Support Manufacturing and Operations by providing strategic direction and tactical support. Troubleshoot daily issues originating from Automation Engineering, i.e. shop floor integration / communication issues between source and consuming systems, and Control System Landscape Systems.

What you bring to Takeda:

  • Bachelor's Degree in engineering or equivalent required.

  • Minimum 10 years industry experience in engineering required.

  • 7+ years of people leadership experience would be ideal

  • Experience with Automation systems, data integration, cybersecurity, and data integrity experience in a GMP environment.

  • Experience industrial automation technologies and emerging (Industry 4.0) technologies to apply to pharmaceutical automation concepts.

What Takeda can offer you:

  • Comprehensive Healthcare: Medical, Dental, and Vision

  • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

  • 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 and company match of charitable contributions

  • Family Planning Support

  • Professional training and development opportunities

  • Tuition reimbursement

Important Considerations:

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

  • Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet, and body. This may include additional hearing protection for loud areas.

  • Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.

  • Work in a cold, wet environment.

  • Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

  • Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This posting excludes Colorado applicants.

#GMSGQ #ZR1 #LI-MA1 #LI-Hybrid

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

USA - MA - Lexington - BIO OPS

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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