Technical Specialist - Commissioning Engineer
- Cork
- Contract
- Commissioning, Qualification and Validation
This vacancy has now expired
One of our global Pharmaceutical clients is looking for a Technical Specialist - Commissioning Engineer to join their team close to the picturesque and historical city of Cork. The site is renowned for manufacturing excellence and plays a vital role in the company's large-scale biotech operations worldwide.
The site has received €130 million in investment over the last five years to continue the growth and expansion of the facility; with new products coming to the site, it is an exciting time to join the team.
Technical Specialist - Commissioning Engineer Responsibilities:
- Ensure the highest Quality, Compliance and Safety standards primarily with equipment qualification, commissioning and validation, project management but relating to all activities.
- Work within a team to enable the team’s performance within the Technology Transfer group and Tech Ops.
- Responsible for the qualification of new equipment to support vaccine manufacturing, providing technical support to the team and leading projects/project management.
- Development and execution of protocols to support equipment qualification.
- Technical Review, ownership of and impact assessment of Global Change management records as required.
- 5-10 years’ process engineering experience in biopharmaceutical/vaccines environment would be an advantage.
- Prior experience with equipment commissioning, qualification, and validation.
- Prior experience with Lyophilisers would be an advantage.
- Demonstrated knowledge in pharmaceutical / biopharmaceutical technical / manufacturing operations. Experience of involvement in a technical project an advantage
- Knowledge of Regulations and applicable standards for Quality, Safety, Regulatory within the biopharmaceutical/vaccine area.
- Hon. Degree or Masters in a Science or Engineering discipline (preferably Biotechnology).
- Preference for Lean Six Sigma qualification or experience of application of Lean principles
- Project management qualification such as, Project Management Professional is desirable
- Prior equipment qualification experience required.
- Managing complex project and aligning key stakeholders.
- Evidence of Continuous Professional Development
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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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
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
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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