Process Engineer (Aseptic Lead)
- West
- Contract
- CAPEX Projects
With worldwide demand for their life-changing oncology treatment increasing; one of our global pharmaceutical clients is looking for a Process Engineer (Aseptic Lead) to join their team to support multiple capital projects taking place onsite in Leinster.
This is a fantastic opportunity to work on a state-of-the art fill-finish facility and the company’s first stand-alone vaccine and biologics plant outside the US.
Role Summary:
- Provide cross-functional development and technical expertise to operations team on the aseptic manufacture of biologics and vaccines for our site. Ensure that objectives are effectively achieved, consistent with our company requirements to ensure compliance, safety, and reliable supply to our customers.
- Serve as COE in Sterile Council and Sterile CoP and provide input to network sterile standards and guidelines.
- Support team member training/development needs and ensure all receive appropriate training.
- Develop and maintain training programs.
- Assist the team with development of objectives and ensures alignment with site goals.
- Foster an environment that allows for progressive, continuous improvement of skills and honest, open feedback focused on how/why to complete aseptic manufacturing process.
- Provide ongoing formal and informal feedback on the Aseptic qualification of the IPT operations team.
- Effectively lead the media fill (Process Simulation) development and execution
- Responsible for contributing to the Cleanroom Operation and contamination (cGMP) in the performance of day-to-day activities and all applicable job functions.
- 3 - 5 year’s operations experience in a sterile manufacturing environment
- Demonstrated ability to coach and lead change.
- Strong Knowledge of Sterile Manufacturing Processes with a focus on delivery and results within highly regulated controlled environment
The candidate must have the rights to work in the location stated in the job advert.
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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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