GerTEK Project Management & Technical Services is one of Ireland’s leading project management and Technical Service companies. Due to continued expansion, we are hiring for an experienced Commissioning & Qualifications Engineer to join our team in the Northwest.
As a Commissioning & Qualifications Engineer you will liaise with the engineering team working on Automation and Equipment Projects. The CQ Engineer will ideally have extensive experience working within an API environment – with Small Volume Continuous Skids, Reactors, Filter Dryers & Nano Filtration Skids.
Skills & Responsibilities
The CQ Engineer is responsible for the safe and compliant delivery of commissioning and qualification for their assigned systems.
Manage projects from scope development, design, build/install and qualify through to handover to User Team.
Vendor and Contractor coordination and supervision (offsite and onsite).
Use scientific, product and process understanding as a basis for developing risk-based approaches to investigations and troubleshooting that will feed into future project.
Develop project scope, cost and delivery time schedule for all Engineering projects, working and collaborating closely with Technical engineering leads to ensure integration into ongoing Validations and/or Technical projects CQ execution for assigned systems (FAT, SAT, RV, IV, OV)
Act as a subject matter expert on: equipment design and qualification; assisting in C&Q execution planning; system boundary definition, system level and component criticality impact assessments, use of quality risk management, User Requirement Specs. And requirements traceability matrices, Document Mgt. Systems, FAT/SAT and C&Q protocol development, project implementation
Comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
Collaborate with multiple partners in achieving excellence in technical transfer programmes.
Serve as technical engineering representative for internal technical group discussions.
Generation of System User Requirements, C&Q Risk Assessments, C&Q plans, test cases and reports.
- Bachelor’s degree or higher preferred; ideally in a Science, Engineering or Other Technical discipline.
- Project management Qualification (PMP) desirable.
- Technical Competencies Required for Commissioning Engineer.
- Minimum 5 years project experience in the commissioning and qualification of pharma equipment and utilities.
- Knowledge of GMP’S, regulatory requirements, equipment commissioning and qualification.
- In depth knowledge and experience of Sterile filling processes and equipment especially
- Experience of executing and/or managing through equipment and process design and validation a sterile environment.
- Good shipping/Filter/Cleaning validation knowledge required.
- Excellent report, standards, policy writing skills required.
- Automation and MES knowledge.
- Proficiency in Microsoft Office and job-related computer applications required.
- Experience in audit preparation and execution desired.
- Having a strong safety experience.
- Have proven record of process improvement implementation.
- Have shown the ability to manage budgets and forecasts and use a formal capital management process.
- Paid Holidays
- On- Site Parking