JOB OFFER

JOB DETAILS

Title:
Automation Engineer
Location:
Sligo
Job Type:
Contract, Permanent

Automation Engineer

Responsibilities

  • Provide technical expertise for the design, configuration, installation, and maintenance of automation software and associated hardware; including interacting with other teams as necessary.
  • Oversight or participation on all automation aspects of future projects including integration of 3rd party equipment to the plant SCADA and BMS systems, data concentration, batch reporting, and data retention.
  • Prepare scopes of work and lead automation resources as required to complete work within the project timelines.
  • Develop equipment specifications in standard documentation – User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS/HDS/SDS).
  • Take programs from concept through execution while managing all stages in the process utilizing a strong set of project management tools.
  • Maintain procedures to meet GMP requirements, CFR’s, and internal company policies.
  • Lead or contribute to programs supporting process commercialization of new products to ensure a smooth transition from development to GMP manufacturing.
  • Participate in operational excellence and continuous improvement efforts.
  • Partner with Quality to ensure a quality and compliant manufacturing environment.
  • Solve technical issues impacting production.
  • Support 24×7 site-based operations.
  • Create and update procedures to drive operational efficiency and compliance.
  • Implement and revise SOPs to conform to the highest industry standards and company policies.
  • Deploy, maintain, and upgrade manufacturing applications.
  • Perform investigations of non-conformances related to automation systems.
  • Analyze and interpret data and make sound technical recommendations on continuous improvements and non-conformance remediations.
  • Execute change controls to update and upgrade automation systems and equipment.
  • Other related duties as assigned.

Qualifications

  • B.S. degree in Engineering, Computer Science, or related technical field, or related technical field, with 5 years’ work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations, or 9 years equivalent work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations.
  • 5 years of experience in cell culture, recovery, purification, aseptic fill/finish.
  • Experience programming, troubleshooting, and maintaining site SCADA/HMI systems (e.g. FactoryTalk View SE, iFix, Wonderware, Emerson/DeltaV).
  • Experience programming, troubleshooting, and maintaining site PLC/BMS systems (e.g. ControlLogix, Siemens TIA/S7).
  • Experience programming, troubleshooting, and maintaining site data historian (e.g. FactoryTalk Historian).
  • Experience in authoring and executing test protocols for automation system level commissioning and qualification.
  • Proven experience applying S88 in an automated environment.
  • Working knowledge of the field device signal wiring practices and panel design, experience with troubleshooting and start-up of control systems, and familiarity with instrumentation.
  • Knowledge of industrial communication protocols such as MODBUS, Ethernet IP, etc.
  • Experience writing and executing change controls in change management systems.
  • Able to develop MS SQL queries.
  • Knowledge of FDA regulations particularly 21 CFR part 11 and GMP systems.
  • Knowledge of Quality by Design, six-sigma, LEAN, and operational excellence tools in creating efficient and quality-driven processes and end products.
  • Excellent oral and written communication skills.
  • Strong project management skillset.
  • Ability to prepare contingency plans and logically work through complex issues in a pressure filled atmosphere.
  • Experience providing technical support on manufacturing issues and able to drive toward issue resolution

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