- Our client, a world leading pharmaceutical company are currently seeking an experience Project Engineer / Process Engineer to join their established team in Blanchardstown, Dublin.
- The candidate will be responsible for planning and executing multi-discipline capital projects in a GMP regulated manufacturing setting.
- Lead and support system improvements, development of specifications, engineering documents and standard operating procedures.
- Lead technical root cause analysis, incident investigations and troubleshooting issues related to manufacturing equipment/systems.
- Support new product introductions or new technology introductions by performing engineering assessments, implementation of system changes and supporting engineering runs.
- Solving complex problems, project management, equipment lifecycle management and operational excellence.
- Develop and manage change control requests per established SOPs and processes.
- Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
- Review, develop and take ownership of the required processes relating to commissioning and qualification, ensuring compliance with all applicable regulatory, functional and internal Quality standards and industry best practice with zero impact to the process development, facilities or operations functions.
- Promote regulatory compliance and alignment of the site with the Business Unit Engineering strategies and objectives.
Core Duties and Responsibilities:
- Plan and execute multi-discipline capital projects through the project delivery phases of plan, design, procure, construct, commission and qualification for cGMP and development facilities, to meet projects’ scope, budget and schedule.
- The successful candidate will be responsible for providing process engineering, and in some cases project engineering, support through all phases of the product lifecycle, including facility design, technology transfer, process validation and routine commercial manufacturing.
- This position will also be responsible for supporting the identification and implementation of continuous process improvements.
- The position requires effective cross-functional collaboration with internal partners including Site Engineering, Manufacturing Operations, Technical Operations and Quality and external contractors.
- Provide support to Manufacturing, Validation, and Maintenance on process equipment and clean utilities when required. Provide support and participate in regulatory inspections.
- Provide Engineering expertise in trouble shooting activities to support manufacturing during process transfer activities or deviation investigations
- Identify and support process optimization initiatives and address opportunities for efficiency and capacity improvements in all areas of manufacturing
- Identify manufacturing best practices and lead or participate in teams to implement best practices.
- Work closely with other site functions to ensure a smooth transition between project and operational phases.
- Participate in capital project teams through all phases of projects; these phases include project proposal/charter, conceptual design, detailed design, equipment procurement, construction, installation, start up, commissioning, reviews P&ID’s, validation, and qualification.
- Assess equipment needs and generate equipment URS and specifications for design or purchase.
- Generate and execute documentation for cGMP validation, requalification and periodic review of systems, equipment & manufacturing processes, including validation plans, annual revalidation plans, risk assessments, IQ/OQ/PQ/QV protocols and reports to maintain the equipment in a validated state.
- Provide technical training on process and equipment as required by Operations.
- Develop and maintain productive links with process equipment & technology supplier and vendors.
Minimum Qualifications and Experience:
- A third level degree in Process Engineering or similar discipline.
- Minimum of 5 – 10 years industry experience.
- Ability to present and explain data to both technical and non-technical forums.
- Self-starter with demonstrated efficient work method.
- Good understanding of cGMP requirements for commercial biopharmaceutical manufacturing.
- Organized analytical thinker with strong attention to detail.
- Excellent oral and written communication skills, including technical writing.
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
GC North Valley Business Centre, Old Mallow Road, Cork, T23 KC67, Ireland.
+353 21 2066178
Please note, we do not require agency assistance with this role.