Automation Engineer

Permanent employee, Full-time · Shannon

Your mission
  • Supports design, development, implementation, and maintenance of computerized process control and monitoring systems (SCADA, PLC and HMIs) in a cGMP Biopharmaceutical facility.
  • Provides technical support for existing systems to enhance reliability and compliance. Recommends and implements practical improvements.
  • Other accountabilities include troubleshooting of equipment systems within the QMS, plus development of improvement plans for greater levels of conformance to cGMP.
  • Provides SME input to preparation of user requirement specifications; authors functional / design / configuration specification documents; also supports validation in an SME capacity, including preparation of test scripts and /or execution of validation protocols for computerized equipment.
  • Automation SME providing technical input to other business processes including change controls, issue investigation, CAPAs and Quality Events generally.
  • Collaborates via multi-disciplinary Engineering team with likes of IT, Manufacturing Validation and other Quality functions to support new project initiatives as well as the manufacturing business units.  
Job Description

Major Activities

  • Collaborates with site and global stakeholders to define and develop automated solutions for equipment, instruments and processes.  Translates business, technical, and regulatory requirements into systems-level solutions during development and deployment of automated processing technologies.
  • Collaboratively works with cross-functional stakeholders to evaluate new technology and acts as an SME for introduction of process automation solutions, deployed into a GMP manufacturing setting.
  • System Owner responsibilities for the site PLC-based Control Systems, Building Management System (Trend), and Environmental Monitoring System (EnVigil), which includes monitoring, maintaining, troubleshooting and investigating relevant control systems hardware and software. 
  • May develop preventive maintenance strategies, SOPs, User Requirement Specifications, Functional Specifications, Design Specifications, Configuration Specifications, Schematics and/or test scripts. 
  • Works with site Validation and QAV functions to ensure automation and control systems are fully compliant with the regulatory requirements. Implementation and validation of computerized systems according to SDLC methodology.
  • Implements change control, CAPA, and issue investigations for automated GMP systems and equipment. 
  • Proactively searches for and implements innovative solutions to improve system performance, reliability, and compliance.
  • Supports training effort for new equipment installations.

Experience and Competency Requirements of the Job Role

  • Include details of education, language skills and experience required
  • Degree (level 8) qualification in Engineering, or another related discipline with minimum 5 years' experience supporting computerized systems in a GMP regulated environment.
  • Good understanding of automation standards and architecture for batch process control, such as S88, and related automation systems, including process control systems, manufacturing execution systems, process data historians (e.g. PI), and laboratory information management systems.
  • Experience in pharma/biopharma manufacturing. 
  • Knowledge and experience of computerized biopharmaceutical equipment, instruments & systems. Experience with one or more of the following is desirable; SCADA, Delta-V, TruBio, MFCS4, Biobrain, Bioflo, BioCommand, and Unicorn software.
  • Knowledge and experience in specifying, installation & configuration, validation and support of some, or all of the following computerized systems; Single-use Bioreactors, Filter Integrity Testers, Cell Counters, HPLC, UFDF, Non-viable particle counters, benchtop balances, benchtop instruments, QC lab instruments (various).  
  • Experience / familiarity with OT Networks and Server infrastructure requirements, OPC technologies & scripting. 
  • Proven programming and maintenance experience with PLCs and Software applications, ideally across a number of industrial platforms.
  • Knowledge of Building Management/Automation Systems.
  • Experience with supporting and maintaining automation and control system infrastructure, including PLCs, remote I/O panels, BMS equipment, wiring and cabling systems, as well as proprietary equipment controllers and control systems. 
  • Experience with various data communication protocols and architectures, including ControlNet, Ethernet I/P, Modbus, BACnet and/or Profibus. 
  • Able to perform and communicate effectively in a multi-discipline team structure. 
  • Experienced in design, selection, configuration, and testing of automated solutions for manufacturing including batch software, PLC based control systems, HMI packages, SCADA systems, and standalone computerized equipment connected to site IT network infrastructure.
  • Familiarity with industry regulations and guidelines including ICH, cGMP, GAMP, PIC/s, HPRA & FDA as they apply to ATMPs.  Experience and knowledge of 21 CFR Part 11 and/or EU Annex 11 requirements is essential.
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About us

MeiraGTx is a clinical-stage gene therapy company focused on developing potentially curative treatments for patients living with serious diseases. We currently have six programs in clinical development including three ocular indications, a salivary gland condition, and a Parkinson’s disease program. Our initial focus on diseases of the eye, salivary gland and central nervous system is based on the significant unmet medical need coupled with the high potential gene therapy has to provide meaningful clinical benefit in these areas. With headquarters in New York and London, our global footprint provides us the opportunity to partner with leading institutions around the world, allowing us to deepen our understanding of diseases and their progression.

Our team was built with deep expertise in gene therapy development, allowing us to efficiently advance our programs from preclinical to clinical development. Our core capabilities in viral vector design and optimization and gene therapy manufacturing give us a differentiated approach to developing gene therapies. Additionally, we are developing proprietary technology to potentially enable innovative gene therapy treatments whose expression can be turned on and off with an easily administered small molecule. We believe temporal control of gene therapy products has the potential to transform the gene therapy landscape.

Our state-of-the-art manufacturing facility, completed in early 2018, was designed to meet global regulatory requirements, including the current good manufacturing practices (cGMP) required by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the U.S. Food and Drug Administration (FDA). The 29,000-square foot facility has the flexibility and capacity to produce sufficient product for all our clinical trials and will scale to commercial capacity.

We are looking forward to hearing from you!
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