Biologics Plant Microbiologist (Start-up)
Looking for an experienced microbiologist to take up a lead role within the Start-Up Biologics facility in Dublin. Excellent package and salary!
These facilities will produce a drug that is first of its kind in regenerative medicine sector in Europe. You will have the chance to set up Micro-Related operations in a way that you think will suit and build a strong team that will report to you!
What The Job Entails
- Supporting the Microbiological activities within the site.
- Ensure compliance with microbiological practices as per regulatory and company policies
- Provide technical support for the qualification and validation of the manufacturing facility which includes Facility, Equipment, Environmental Monitoring program, Media Fills, Container Closure Integrity Validation, Process Validation and Continued Process Verification (process monitoring).
- Assist with Method Transfer/Validation, Contamination control strategy, Aseptic training, Environmental Monitoring program, raw materials testing, product testing, in-processing testing, process validation and facility validation.
- Set-up Microbiology Laboratory Start-up activities which include the development of URSs, Risk Assessments, Protocols, Reports, SOPs, EOPs work instructions, procurement and qualification of equipment, software and utilities/facilities.
- Ensure audit readiness
- Lead and participate in the technical transfer / validation of microbiological testing procedures including Mycoplasma, Sterility testing and Endotoxin testing.
- Support the investigation into any non-conformance, instrument malfunction, accident or other abnormal occurrence. Ensure that any Out of Specification (OOS) or Out of Trend (OOT) analytical results are managed as per SOP.
- Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event.
What Is Required For This Job
- BSc Degree in Microbiology or similar
- Strong background within GMP facilities in a capacity of QC Microbiologist and above
- Previous experience in Biologics facilities
- Extensive experience of microbiology testing including Contamination Control. Sterility, endotoxin, mycoplasma and Environmental Management
- Thorough knowledge of GMP and current FDA & EMEA regulations
- Previous experience managing the performance of individual team members and the overall team
- Understanding of requirements within Start-Up facilities.
Should you be interested in chatting more, or are looking for any roles within pharma, biologics or med-dev - be it QC, QA, QP, Engineering or Senior Management Positions - let me know (Andrius Antanaitis) and we can schedule a call. Email firstname.lastname@example.org or call direct to 01 4744 692.