Current Jobs
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.
Job Features
Job Category | CQV Engineer |
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 Martin Lynch on 087-344 3581.
Email CVs to mlynch@mile.ie
Job Features
Job Category | AIT Engineer |
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 Martin Lynch on 087-344 3581.
Email CVs to mlynch@mile.ie
Job Features
Job Category | OEM Engineer |
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 Martin Lynch on 087-344 3581.
Email CVs to mlynch@mile.ie
Job Features
Job Category | Utilities Automation Engineer |