Process Engineer - Pharma
Job Type | Contractor |
Area | Sligo, Ireland |
Sector | Engineering |
Start Date | |
Advertiser | David Connolly |
Job Ref | 1003370 |
Job Views | 119 |
- Description
Process Engineer
Team Horizon is seeking a Process Engineer for a leading pharmaceutical company in Sligo.
Joining team of 8, reporting to the NPI Technical Manager – team is divided into NPI/Tech Transfer and Manufacturing Support.
Will be based at the Biologics site – parental drug product fill finish facility, supporting design, qualification, and management of single use technologies. Will interact with vendors/manufacturers and review drawings for connectors/filters etc. Will also work closely with manufacturing, ensuring Operators are trained in single use technologies. Will be involved in investigations/troubleshooting of issues as well as process improvements.
Why you should apply:
- Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
- You enjoy working on exciting projects and want to work with a global manufacturing site in Sligo.
What you will be doing:
- Process Engineer for Fill Finish Manufacturing site
- Leverage detailed understanding of aseptic fill finish manufacturing for design input into equipment commissioning and qualification.
- Responsible for single use design, onboarding, and qualification.
- Act as site representative on cross-site teams for standardization of single use assemblies and procedures.
- Work with supplier technical teams to maintain good relationship.
- Technical representative on site cross-functional team for design updates and introduction of new single use to site.
- Author of process flow diagrams for new product introductions / technology transfers.
- Responsible for aligning PFD between products and standardizing for NPI.
- Aligns with NPI Lead for product transfer on requirements for new products or process improvements.
- Technical SME for investigations, responsible for process improvements and monitoring of process efficiency.
- Author gap assessments, facility fit studies, process safety and risk assessments for NPI.
- Author scientific reports and technical documentation and presentations to document and communicate project status to internal and external stakeholders.
- Understand and ensure compliance with safety, regulatory and compliance expectations.
- Other duties as assigned.
What you need to apply:
- Third level degree in Chemical Engineering, Bioprocess Engineering.
- 3-5 years’ experience in biopharmaceutical industry.
- Biologics experience with at scale manufacturing in fill finish facility in a technical role.
- Experience with new product introductions / technology transfers to fill finish manufacturing facility.
- Experience in single use technology.
- Experience in isolator technology.
- Experience in SAP / Trackwise.
- Single use Technology: design and qualification in drug product/Fill finish or drug substance is also applicable.
- Experience dealing with vendors.
- Operations or design background in single use technology and experience in onboarding single use into a facility.
- Ability to interact with Operations/Manufacturing on single use training/continuous improvement initiatives.