Senior Process Engineer is required for a global Biopharmaceutical company in Cork. The facility specialises in the fermentation, purification and sterile filling of biotech products, as well as supporting product development and clinical trials. The site has recently received significant investment to increase the onsite capabilities and has a significant European role in this global organization. The Site mission is "to be a globally competitive BioPharma site with proven capability, excellence in compliance, and flawlessly supplying products that meet customers' expectations".
The team on site are focussed on excellence, innovation, quality, compliance and teamwork to support their strategy to meet the needs of their global patients.If you want to work on a manufacturing site with innovative technical capabilities and with an opportunity to support a wider European team then this is the opportunity for you.
Excellent opportunity for a Senior Process Engineer to work in/as part of Technical Operations with responsibility for ensuring that internal and external manufacturing operations remain operational, continuously improve, and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities, and Validation.
The Senior Process Engineer will be responsible for:
- Work with External Partners to achieve business goals and to establish a common culture that benefits our company, External Partners, and patients.
- Responsible for technical activities for the commercial manufacturing process at the External Partner, which includes authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events.
- Responsible for technical transfer activities, as applicable, through authorship and/or review of required GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, etc.) and regulatory filings.
- Translate understanding of GMP requirements and current regulations and develop standardized work to meet these requirements by partnering with Operations, Quality, and External Partners.
- The Senior Process Engineer requires:
- Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field.
- Minimum of 4 years post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, Engineering, and/or Maintenance
- Demonstrated ability to independently manage projects/work to schedule/deadlines such as Operations, Technical Operations, Technology, Engineering, and/or Maintenance
- Strong communication and teamwork skills
Call Kieran O'Sullivan in LSC on 021 4777 329 to discuss this new Senior Process Engineer role in more detail or apply directly via this advert.