Company Background
HiTech Health focuses on enabling healthcare companies to develop, launch and supply products to the market. The company was established in 2013, bringing together an experienced and multi-disciplinary team from across the pharmaceutical, biotechnology and medical device industries. Operating internationally, HiTech Health supports cell and gene therapy companies and sterile medicinal products developers to develop, manufacture and supply life-changing therapies to patients.
Job Description For Microbiologist / Quality Control Analyst
Due to rapid growth, HiTech Health are seeking to hire an onsite QC/Micro Analyst for a new cell and gene therapy facility in County Galway. This is an initial 1-year full time contract with the potential to extend to permanent contract. It is an exciting role for an aspiring professional to join a growing organisation to work on all microbiological matters within the GMP sterile manufacturing division of HiTech Health. The candidate will work closely with the production team and quality function to support the manufacturing and testing of a range of cell and gene therapy products and sterile medicinal products.
Principle Responsibilities
- Authoring microbiological related plans, protocols, reports, Work Instructions (WIs), Standard Operating Procedures (SOPs) and other relevant GMP documents as pertains to microbiological activities.
- Performing environmental monitoring performance qualifications and routine environmental monitoring programs.
- Generate environmental monitoring trending data and associated reports in line with internal reporting timelines
- Perform a range of microbiological and QC laboratory assays, including but not limited to: Growth promotion testing, Gram staining, Colony enumeration and microbial identification, Sterility testing and endotoxin testing, Mycoplasma testing (e.g. PCR-based and/or culture methods) and Flow cytometry-based assays (where applicable)
- Support QC laboratory testing outside of core microbiology where required
- Subject matter expert and lead in all microbiological related Out of Specification (OOS) or Out of Trend (OOT) analytical results, deviations, investigations, corrective or preventive actions
- Contribute to aseptic process simulations/media fills as required.
- Train others in laboratory procedures where required and execution of analytical testing for microbiology requirements to support any QC, R&D or Manufacturing activity.
- Participate at regulatory authority and customer inspections and meetings as microbiology representative
Essential Requirements:
- Minimum of Honours Bachelor’s degree in a relevant discipline (Microbiology, Biology, Chemistry or similar).
- 1-3 years Microbiology experience in a GMP facility.
- Thorough knowledge of US and European GMPs and Pharmacopeia.
- Expertise in contamination control of GMP cleanroom facilities.
- Subject matter expert with practical experience of environmental monitoring.
- Strong understanding and application of Good Documentation Practice (GDP), with experience maintaining clear, accurate and inspection-ready documentation.
- Attention to detail and application of laboratory safety practices.
- Excellent written and verbal communication and the ability to multi-task across multiple products and programs is highly important.
- Proficient in technical writing and experience in creating; SOPs, work instructions, qualification/validation protocols, qualification/validation reports, and summary reports to support FDA and EMA filings.
Desirable Requirements:
- Experience with final product tests such as sterility, mycoplasma or endotoxin including PCR-based assays and/or flow cytometry (ideally at least one).
- Experience working in a small-medium company and/or facility start-up.
- Knowledge of emerging technologies, trends, and methodologies.
Salary Range: Negotiable. Salary is commensurate with experience and qualifications for this key position.
Working hours: Working hours will be 9am – 5.30pm onsite daily. The nature of the work may require flexibility in working times.
Location: Location subject to change between our two sites in Galway ie Gteic An Spidéal, Páirc na Meáin, An Spidéal, Galway, H91CH01 & An Tulach 1, Eastat Tionscail na Tulaigh, Tully, Ballynahown, Galway, H91 AK24
Start date: On completion of recruitment process
Closing date: For receipt of applications is May 31, 2026. We reserve the right to re-advertise or extend the closing date for this job post.
We reserve the right to re-advertise or extend the closing date for this job post.
HiTech Health is an equal opportunities employer.
