Posted to MedZilla on 7/23/2019

Takeda Pharmaceuticals

US-CA, IT Systems Engineer II SR0032688-MZ


This position is responsible for System administration of the automation systems and executing automation projects related to implementation of a process control system. You will execute system administration tasks for all automation systems. System administration requires an in-depth knowledge of implementation of infrastructure for automation systems in a pharmaceutical environment. You will carry out scope definition /clarification exercises to properly and completely characterize automation requirements and be responsible for project-related functions including design, specifications, budgeting, scheduling, resource management, construction management, commissioning and start up. Project scope requires an in-depth knowledge of pharmaceutical process equipment automation related to process control systems, electronic batch records, DeltaV, PLC, OPC, BAS and general working GMP knowledge of pharmaceutical manufacturing facilities and all major utilities.

Candidate will be expected to displays standard engineering principles to resolve difficult problems, from conception to final design with team input, and plan, schedule and lead project assignments in the evaluation, selection and adaptation of various engineering techniques, procedures and criteria with minimal guidance.

Essential Duties and Responsibilities

  • Assess, support and proactively improve the current DeltaV control system hardware, software, configuration and VB scripts.
  • Complete risk assessments for changes and improvements to all DeltaV system hardware and associated configuration; analyze, code and formally test the proposed changes on DeltaV Simulation system; implement changes on Production system. Troubleshoot, diagnose and assist in repair of DeltaV system controllers, Device Net, Foundation Fieldbus and Ethernet networks.
  • Troubleshoot, diagnose, mitigate and improve the Building Automation System (BAS).
  • Administer and maintain the Building Automation System (BAS).
  • Administer and maintain the DeltaV system.
  • Support PLC/HMI based control systems for various stand-alone equipment.
  • Review, continuously update and standardize across the site current technical. documentation and drawings for Delta V and BAS control systems: User Requirement Specifications, Functional Specifications, Design Specifications, electrical/control drawings, control network diagrams, system configuration, control components h/w and s/w settings, panel layouts; BOMs, and Spare Parts lists.
  • Update Standard Operation and Preventive Maintenance Procedures for the existing equipment and control systems.
  • Revise and execute SOP for the control systems software configuration and application installation, back up and restoration.
  • With minimal guidance, as the Controls Engineering SME, lead automation and controls work for the multiple small functional projects and/or a large capital/functional project. Engineer and manage process equipment/control systems reliability improvement, optimization, upgrades as well as the new equipment control systems implementation from the concept to commissioning and validation. Ability to prioritize multiple tasks.
  • Train Control System, Instrumentation and Metrology technicians on control system functionality, instrumentation configuration, troubleshooting and diagnostic methods and techniques. May supervise/coordinate technicians on assigned work. Train Quality Operation, Compliance and Manufacturing personnel on DeltaV and EBM functionality.
  • Develop and formally execute Control System/Equipment Installation, Operation and Performance Commissioning protocols for modified or new equipment and control systems. Assist in preparation and execution of the Qualification protocols.
  • Partner with Process, Production Automation and Reliability Engineering groups, Refrigeration, Maintenance and Metrology personnel to assure continuous improvements in production operations and increase throughput.


  • Proficient in MS Office, MS Project, Visio, Windows XP/7.
  • Display a solid understanding of theories/practices utilized by other disciplines outside of primary area of expertise.
  • Must be able to provide solutions that reflect understanding business objectives and cost implications.
  • Ability to convince management on courses of action with minimal assistance using both written and verbal methods.
  • Effectively operate in cross-functional teams, coordinate contractors, and direct activities of technicians without guidance.
  • Successful track record of managing wide-ranging activities within the business unit.
  • Excellent communication, organizational and technical writing skills; willing to work in a team environment. Self-motivated, ready to work with minimum supervision; responsible, reliable.

Education and/or experience

  • BS in Electrical, Computer Science, Chemical or Mechanical Engineering is required.
  • 3-5 years of Engineering experience in manufacturing environment, preferably in pharmaceutical or food processing facilities, specifically Plasma fractionation, design, installation and commissioning of projects; or 5 years, working as a system integrator or Control System/Process Engineer in Engineering Design firm.
  • Experience with Distributed Control System configuration and operation, especially Emerson Delta V and Siemens BAS. Experience with Delta V Batch Processing Automation, module and phase programming.
  • Experience with Server administration, Virtualization and Network administration.
  • Working knowledge of PFD, P&ID and loop diagram standards; temperature, pressure, flow, weight, humidity, conductivity, pH measurement and instrumentation.
  • Familiarity with pharmaceutical industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP.
  • Experience in PLC/HMI integration.
  • Experience with hands-on troubleshooting with some of the following systems: Apogee InSight DB, Allen Bradley PLCs and PaneView Human Machine Interfaces (HMIs), Delta V hardware and software. Hands-on experience with automation networks and Ethernet industrial networks.

Physical Demands

  • Must be able to lift, push, pull and carry up to 10 lbs.
  • In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.

Working Environment

  • Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
  • No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
  • Will work in a cold, wet environment
  • Must be able to work multiple shifts, including weekends.
  • Must be able to work overtime as required. (only for non-exempt positions)
  • May be required to work in a confined area.
  • Some Clean Room and cool/hot storage conditions.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

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