Mechanical SME
- Dublin
- Contract
- CAPEX Projects
One of the top 10 best companies to work in Ireland is looking for more engineers for their large-scale new facility north of Dublin. Is this you?
An exciting project there is lots of opportunity to learn new technology and develop current skills within a fast paced €1 billion project. This fantastic client offers the opportunity to work within a large-scale environment with cutting edge technology.
Responsibilities:
- Ensuring all the modifications or additions to systems are in compliance with all Regulatory requirements including Quality (cGDP/GMP’s), EHS, CE Compliance, Global Engineering, design & construction directives, requirements & procedures, as well as all Local Regulatory requirements as they relate to the Mechanical discipline.
- Developing user requirements for new equipment and modifications to existing equipment and systems from concept through supporting installation with the collaboration of stakeholders.
- Developing, reviewing and updating the CMMS data, calibration data sheets, Spare parts requirements, PMs, PdMs, job plans etc. to ensure that all maintenance schedules are designed to deliver cost effective, efficient reliability based maintenance programmes maximising uptime.
- Performing and facilitating root-cause failure analysis (Cause Mapping) on chronic/critical/high impact failures.
- As Mechanical SME support all compliance - complete risk assessments, RCA investigations, identify appropriate CAPAs etc. to ensure no re-occurrence of issues.
- Review / approve / reject engineering change controls & CC Impact assessments for equipment and System
- Raising Project Request Documents (PRD’s) to implement projects for site improvements or addition of new equipment
- Developing/implementing new capital project scopes, performing project management for equipment related modification projects on assigned systems as required
- Be an advocate of continuous improvement.
- Support the review and approval of site procedures as required
- Must be a team player prepared to lead, work effectively and efficiently in a team-based environment.
- Demonstrated ability to provide solutions that reflect understanding of business objectives and cost implications.
- Detailed knowledge and experience in operating and design of Utility equipment and systems.
- Detailed knowledge and experience in the pharmaceutical/biopharmaceutical industry, with in-depth knowledge of regulatory requirements (safety and quality).
- Experience dealing with regulatory agencies.
- Experience with complex projects and working in or around operating facilities.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
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