Role Responsibilities

• The CQ Engineer reports to the CQ Area Lead and is responsible for the safe and compliant delivery of verification activities for their assigned systems.
• Commissioning and Qualification of API Process Equipment (Reactors, Vessels, Centrifuges, Filters, Dryers), HVAC (AHUs, Flow Hoods, Balancing Air), or Utilities (Clean, Black, Grey).
• Generation of System Traceability Matrices, C&Q Risk Assessments, C&Q plans, test cases and reports.
• Vendor and Contractor coordination and supervision (offsite and onsite).
• Review and acceptance of contractor and vendor handover documentation.
• Acceptance of systems at Mechanical Completion (following walk-down, punchlisting, etc.).
• Safe set-up of systems (PSSR, LOTO, Valve Line-ups).
• Safe energization and start-up of equipment and systems.
• Document generation and execution for assigned systems (FAT, SAT, RV, IV, OV).
• Running recipes, sequences and functional testing via DCS (DeltaV).
• Troubleshooting and resolving design, installation and operational issues for systems under test.
• Project Change Control and Discrepancy Management for assigned systems.
• Handover of systems to User Team.
• Abide by all safety requirements and procedures pertaining to their role; serve as a positive model to others in this regard.

Role Requirements:

• BS Engineering or Science (or equivalent experience).
• Minimum 5 years project experience in the commissioning and qualification of pharma API equipment, HVAC Systems or Utilities.
• Knowledge of Small Molecule Unit Operations, Continuous Manufacturing and/or ATEX environments is desirable.
• Self-motivated, proactive approach with a commitment to meet deadlines.
• Knowledge of GMP’S, regulatory requirements, equipment commissioning and qualification.
• Good written and verbal communication skills with both technical and non-technical staff.
• Delta V experience desirable.
• Kneat experience desirable.

Responsibilities

• Responsible for delivery of Automation and IT scope on one or more lab projects in the portfolio of capital projects
• Required to work closely with the AIT teams responsible for the full Automation and IT scope and with vendors / partners with responsibility for qualification of laboratory systems.
• Partner with local project teams to deliver Automation and IT aspects of Laboratory capital projects.
• Develop & Review SDLC deliverables.
• Liaise with site AIT group to add input to site SOPs for lab systems.
• Author/Review/Approval of qualification documents for lab systems – RS, CS, RTM etc.
• Generation of requirement and configuration specification and IOQ test protocols. 
• Participate in execution of IOQ protocols for lab analytical instruments
• Input to the development of project schedules and document trackers.
• Generate risk assessments/variance documentation and work with others to close out same.
• Work closely with the DDQ function to ensure compliance with site Quality standards.
• Interface with site teams for system deliverables such as Empower, LIMS, MODA, LabX and Acronis etc.
• Drive efficiencies in execution of projects to reduce costs and cycle times based on standards
• Ensures that SDLC is appropriately applied.

Qualifications & Education

• BSc in Engineering, Computer Science, and or other technical degree.
• Excellent facilitation, problem solving, collaboration and decision-making skills.
• Ability to multitask and to handle tasks with competing priorities effectively and engage with stakeholders.
• Experience with Laboratory systems such as Empower LIMS, MODA, LabX and Acronis.
• Experience in automation equipment used in biopharma laboratories is an advantage.

To apply contact Lisa Cooney at lcooney@mile.ie

Responsibilities

• The ideal candidate must have knowledge of process manufacturing, field instrumentation, control system installation and implementation expertise in all of the following project phases: Requirements documentation, detailed design generation, implementation, system integration, testing and on-site startup. Plans and coordinates technical design and engineering implementation of project work.
• Design, configuration, integration and implementation of process control solutions for various industries.
• Develop P&IDs and loop descriptions for various plants, processes, and/or equipment.
• Develop User Requirement Specifications.
• Develop software and hardware design specifications.
• Design, write, implement, test and document PLC and HMI software.
• Develop control system validation/testing protocols.
• Specify and purchase process instrumentation.
• Specify and purchase PLCs, drives, and other electrical components and equipment.
• Develop electrical panel schematics.
• Develop scope of supply documents.
• Assist with estimates of man-hours required to complete projects.
• Manage automation projects as assigned.
• Monitor progress of projects.
• Install, test, and start-up control systems on-site.
• Train operators and engineers on control systems.
• Adherence to the Milestone Solutions QMS

Qualifications & Education

• Thorough knowledge of process instrumentation and control systems.
• Experience working with a variety of control systems including DDC, DCS and PLCs.
• Knowledge of and familiarity with the National Electric Code (NEC) and international standards.
• Experience designing and programming control systems with emphasis on PLCs, SCADA or HMI systems.
• Experience in commissioning and startup of control systems is required.
• Ability to work with plant engineers, external vendors, operators and management to manage projects and assignments is essential.
• Ability to troubleshoot control systems from the field element up through operator interfaces and databases.
• Experience with control system networking technologies and PC networking technology.
• Experience working with SQL Server, Oracle, or other relational databases.
• Experience with Visual Basic scripting.
• Excellent written and verbal communication skills.
• Strong interpersonal skills and the ability to work in a team environment.
• Ability to work effectively in a fast paced multi-tasking environment.
• Experience in biotech/pharma, water, wastewater, medical device, or the food industry is required.
• Experience with Emerson Delta V DCS is a plus.
• Specific knowledge of cGMPs and batch process control in the life science industry with validation experience is a plus.
• Knowledge of 21 CFR Part 11 requirements is a plus

To apply contact Lisa Cooney at lcooney@mile.ie

The Utilities Automation Engineer will be a member of the Automation team providing project support to vendor delivered automation solutions for the site utility computer systems.

• The candidate will require to manage the deliverables from vendors to ensure they align with the project / change requirements and that they are compliant with the SDLC needs.
• Required to provide periodic support to operations in the event of a computer system failure.
• You will be responsible for development of requirements in conjunction with the project team and the business.
• Review of vendor supplied documentation (designs, testing documents, work statements, etc) to ensure it aligns with the requirements and meets the necessary document standards (SDLC).
• Provide support during the vendor site visits for the deployment and testing of software.
• Provide day to day support to Operating Areas for utilities automation system upsets either directly or by engaging vendor support.
• Work collaboratively to drive a safe and compliant culture
• 5+ years’ experience in automation project activity
• Experience with automation system implementation and validation
• Working knowledge of DCS/PLC/BAS systems
• Previous experience supporting utilities systems (e.g., chillers; water treatment; boilers) would be advantageous
• Background in electrical or instrumentation would be advantageous

To apply contact Lisa Cooney at lcooney@mile.ie