Automation Engineer Position Available In Middlesex, Massachusetts

Job Description:

By clicking the “Apply” button, I understand that my employmentapplication process with Takeda will commence and that theinformation I provide in my application will be processed in linewith Takeda’s Privacy Notice and Terms of Use . I further attestthat all information I submit in my employment application is trueto the best of my knowledge. Job Description About the

Role:

As anAutomation Engineer I role, you will work in a hybrid position andis part of the Automation engineering group located at theMassachusetts Biological Operations (MBO) site of TakedaPharmaceutical Co. Ltd. The scope of responsibility will includeoperational, support of PLC, DCS, Manufacturing Execution systems,and ancillary data systems used to control and collect data formultiple building and manufacturing unit operations ensuringuninterrupted 24/7 manufacturing operations and remain within theirvalidated state and regulatory compliance The main manufacturingsystems include incubators, bioreactors, chromatography skids,filtration skids, media and buffer preparation vessels,intermediate totes, CIP and caustic distribution skids, COPwashers, and autoclaves. You will report to Automation Lead.

Howyou will contribute:

Be the Primary contact for our Control Systemoperations to MBO groups such as Manufacturing, Engineering,Facilities. Provide direct and call support (Analizing onlineProcess Logic, Providing information, diagnosing andtroubleshooting incidents, logging activities and reporting out ofthese support activities) to Shift Mechanics and Manufacturingtechnicians during operations.

Perform Routine operationalactivities including:

User Management, Backup and Restore, SecurityManagement, System performance monitoring, Periodic Reviews,Incident and Change management. Be accountable for systemperformance, continuous improvement, and iterative innovation.

Develop subject matter expertise on assigned unit operations.

Support tasks and activities related to project engineering forsmall to medium-scale projects. Maintain the design and operabilityof all PLC, DCS, Manufacturing Execution systems, and ancillarydata systems used to control and collect data for multiple buildingand manufacturing unit operations ensuring uninterrupted 24/7manufacturing operations and remain within their validated stateand regulatory compliance. cause unknown with no product impact)complexity. Expectation to carry a smartphone device for immediateassistance. Build work orders in Maximo using tools and followingGood Engineering Practices (GEP), Good Automated ManufacturingPractices (GAMP), and current Good Manufacturing Practices (cGMP).Investigate and document automation related deviations related tocompliance and environmental health and safety (EH&S) usingbusiness tools/systems like Trackwise. Establish causes using tools(5-Whys, Fish-Bone) and identify design solutions as part ofCorrective and Preventative Actions (CAPAs) including StandardOperating Procedure (SOP) changes. Perform data analysis toidentify trends in equipment performance using tools such as PIHistorian, Minitab, Excel, Spotfire, and PowerBI. Build periodicpreventive maintenance (PM) work orders, documenting resultsthrough the Maximo business system. Perform system & applicationbackups, virus protection, operating system patches Help withcompliance and safety inspections/audits by compiling andpresenting data for the audit committee and auditors. Attend dailytier, investigation, design, leadership and strategy meetings toensure and collaboration. Support the project lifecycle (conceptualdesign, basic design, detailed design) for small and medium-scaleprojects under the supervision of senior or principal engineers.

Responsible for delivery of deliverables/solutions, meetingtechnical quality standards and delivery of engineering solutionsthat contribute to project success. Support front end engineeringdesign (FEED) activities including development of technoeconomicfeasibility assessments, options analysis, project proposals, andbasis of design related to equipment modifications and continuousimprovements. Help develop control algorithms, alarm strategy, andsequence of operations. Analyze data and create detailed technicalreports to inform decision-making. Collaborate with externalvendors to support troubleshooting activities, feasibilitywalkthroughs, installation, construction, and maintenance events.

Maintain drawings, including Piping & Instrumentation Diagrams(P&ID), Physical or Logical Architecture Diagrams, UserRequirements Specifications (URS), Functional RequirementsSpecifications (FRS), or Configuration Specifications (CS) Usebusiness tools such as COMOS and Veeva for documentation.

Participates in in-depth design reviews and risk assessments usingbasic tools (PHA, JHA) to ensure the robustness and reliability ofdesign solutions. Learns industry standards such as, ISA S-88,S-95, GAMP, and

ASTM 2500

Provide support for system development,and testing both software and hardware acceptance tests (SFAT andHFAT) at vendor sites during projects, as required. You will learnProgramming Standards and draft and build commissioning testprotocols (SAT, CTP, IOV) on the floor to establish robustautomation implementation and operation using Kneat. Review testprotocols (CTP, IOV) and support discrepancy resolutions during theexecution of installation, operational, and performancequalifications (IOPQ). Maintain and review work instructions (WI),standard operating procedures (SOP), guidance, and standards forautomation-owned programs, including Building Management System(BMS), Critical Monitoring System (CMS), and Process ControlSystems (PCS) for example Develop, review, and enhance playbooks toensure audit readiness. Ensure the lifecycle maintenance ofequipment specifications, drawings, datasheets, and COMOS databasemetadata owned by the automation engineering team. What you bringto

Takeda:

B.S./M.S.

in Chemical Engineering, ElectricalEngineering, Computer Sciences, or equivalent degree Proficiencywith Microsoft products; ability to learn additional softwareapplications, as the need arises

• TrackWise experience would beideal.

Experience in a cGMP Engineering role within pharmaceutical,biotechnology, or other FDA regulated industry. Understanding ofinstrumentation, and its configuration, Industrial Controlnetworking such as Ethernet IP, Profibus, or AS-I networks.

Programmable Logic Controller or Distributive Control Systemprogramming, and Data Historian and Report Configuration. Knowledgein at least one relevant automation system such as Allen Bradley orSiemens PLC platforms, Delta V DCS platform, Schneider Electric orJohnson Controls BMS platforms,iFix, Factory Talk, or ignitionSCADA systems, data systems (PI, IP21, Crystal Reports, rtReports,etc.) and data integration solutions (OPC, Kepware, Matrikon, LabX,WebAPI, etc.) Establishes rapport, builds relationships that createnetworks with those individuals and stakeholder groups critical toshort and long term goal attainment. This role is consider Hybridat the Massachusetts Biological Operations (MBO) site of TakedaPharmaceutical Co. Ltd., A successful candidate will be required tobe on-site a minimum of 3 days per week and as business needsrequire and available for on-call support 24/7. Required to carry acellular device and be available to support requirements at allsites. Ability to work at all Takeda MABIOPs locations (Cambridge,N Reading, Belmont and Lexington)

Important Considerations:

AtTakeda, our patients rely on us to deliver quality products. As aresult, we must follow strict rules in our manufacturing facilitiesto ensure we are not endangering the quality of the product. Inthis role, you may: Work in a controlled environment requiringspecial gowning and wear protective clothing over the head, face,hands, feet and body. This may include additional hearingprotection for loud areas. Need to remove all make-up, jewelry,contact lenses, nail polish and/or artificial fingernails while inthe manufacturing environment. Work in a cold, wet environment.

Work multiple shifts, including weekends, or be asked to worksupplemental hours, as necessary. Work around chemicals such asalcohol, acids, buffers and Celite that may require respiratoryprotection.

More about us:

At Takeda, we are transforming patientcare through the development of novel specialty pharmaceuticals andbest in class patient support programs. Takeda is a patient-focusedcompany that will inspire and empower you to grow throughlife-changing work. Certified as a Global Top Employer, Takedaoffers stimulating careers, encourages innovation, and strives forexcellence in everything we do. We foster an inclusive,collaborative workplace, in which our teams are united by anunwavering commitment to deliver Better Health and a BrighterFuture to people around the world.

GMSGQ ZR1

Takeda Compensationand Benefits Summary We understand compensation is an importantfactor as you consider the next step in your career. We arecommitted to equitable pay for all employees, and we strive to bemore transparent with our pay practices.

For Location:

USA

• MA•Lexington•

BIO OPS U.S.

Base Salary Range:

$56,000.00

• $88,000.

00The estimated salary range reflects an anticipated range for thisposition. The actual base salary offered may depend on a variety offactors, including the qualifications of the individual applicantfor the position, years of relevant experience, specific and uniqueskills, level of education attained, certifications or otherprofessional licenses held, and the location in which the applicantlives and/or from which they will be performing the job.

The actualbase salary offered will be in accordance with state or localminimum wage requirements for the job location. U.S. basedemployees may be eligible for short-term and/orlong-termincentives. U.S.based employees may be eligible toparticipate in medical, dental, vision insurance, a 401(k) plan andcompany match, short-term and long-term disability coverage, basiclife insurance, a tuition reimbursement program, paid volunteertime off, company holidays, and well-being benefits, among others.

U.S.based employees are also eligible to receive, per calendaryear, up to 80 hours of sick time, and new hires are eligible toaccrue up to 120 hours of paid vacation. EEO Statement Takeda isproud in its commitment to creating a diverse workforce andproviding equal employment opportunities to all employees andapplicants for employment without regard to race, color, religion,sex, sexual orientation, gender identity, gender expression,parental status, national origin, age, disability, citizenshipstatus, genetic information or characteristics, marital status,status as a Vietnam era veteran, special disabled veteran, or otherprotected veteran in accordance with applicable federal, state andlocal laws, and any other characteristic protected by law.

Locations USA

• MA•Lexington•BIO OPS Worker Type EmployeeWorker Sub-Type Regular Time Type Full time Job Exempt Yes It isunlawful in Massachusetts to require or administer a lie detectortest as a condition of employment or continued employment.

Anemployer who violates this law shall be subject to criminalpenalties and civil liability.