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Job Description

Job Title: Senior Automation Engineer (Delta V)

Location: Lexington, MA

About the role:

As a Senior  Automation  Engineer role, you will provide operational, and project support of PLC, DCS, Manufacturing Execution systems, and ancillary data systems used to control  and collect data for multiple building and manufacturing unit operations. You will be the primary contact for our Control System Platforms and be a Subject Matter Expert for control system operations to MBO groups such as Manufacturing, Engineering, Facilities, etc. You will provide support  to our automation operations  team of manufacturing  operations.

How you will contribute:

• Be accountable for system performance, continuous improvement, and large-scale innovation.  

• Be a subject matter expert on multiple assigned unit operations and Develop subject matter expertise on assigned automation platform.   

• Be a consultant to automation engineering and site leadership on major functionality challenges and industry best practices about design, policies, business processes, goals, and objectives.

• Maintain the design and operability of all PLC, DCS, Manufacturing Execution systems, and ancillary data systems used to control and collect data for various building and manufacturing unit operations ensuring uninterrupted 24/7 manufacturing operations and remain within their validated state and regulatory compliance. 

• Support the primary operations team and help troubleshoot and Resolving Issues. 

• Expectation to rotate on call to provide immediate assistance. 

• Accountable for completion of Automation Engineering owned CAPAs and Change Controls.

• Lead the project lifecycle (conceptual design, basic design, detailed design) for small to large-scale projects under the supervision of principal engineers. 

• Use industry standards such as, ISA S-88, S-95, GAMP, and ASTM 2500.

• Provide support for system development, implementation, and testing both software and hardware acceptance tests (SFAT and HFAT)  at vendor sites during projects, as required. 

• Use Programming Standards.

• Draft and implement commissioning test protocols (SAT, CTP, IOV) on the floor to establish robust automation implementation and operation using Kneat. 

• Review and approve test protocols (CTP, IOV).     

• Support discrepancy resolutions during the execution of installation, operational, and performance qualifications (IOPQ).

• Develop, Improve and Maintain, work instructions (WI), standard operating procedures (SOP), guidance, and standards for automation-owned programs, including Building Management System (BMS), Critical Monitoring System (CMS), and Process Control Systems (PCS) for example.

• Demonstrate selecting methods and techniques for obtaining solutions.  Networks with senior internal and external personnel in own area of expertise.

• Normally receive little instruction on daily work, general instructions on new assignments. 

What you bring to Takeda:

• B.S./M.S. in Chemical Engineering, Electrical Engineering, Computer Sciences, or equivalent degree

• Minimum of 5 to 8 years of relevant industrial controls experience and demonstrated accomplishments.

• Experience in a cGMP Engineering role within pharmaceutical, biotechnology, or other FDA regulated industry. 

• Expertise in Delta V.

• In-depth knowledge of Downstream Operations including Recovery, Chromatography, Ultra Filtration / Dia-Filtration and viral filtration.

• Demonstrated experience with the application of project management methodology and delivering solutions that meet business objectives for complex programs/initiatives.  

• Experience with batch and continuous manufacturing operations in pharmaceutical and Biotech Industries would be ideal.

• Establish relationship, builds relationships that create networks with them and stakeholder groups critical to short- and long-term goal completion.

• Familiarity working in a cGMP environment to ensure compliance with company policies and procedures.

• Maintain awareness around cGMP and quality; follows compliance requirements.

• Work at all Takeda MABIOPs locations (Cambridge, N Reading, Belmont and Lexington)

• Travel: You may travel for business reasons (e.g. training, meetings, factory acceptance testing). Travel may include international travel. Travel should not exceed 20%.

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:

• May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.

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

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

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.

#GMSGQ 

#ZR1 

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

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U.S. Base Salary Range:

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.

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