Do you take up the leading role in our site microbiology activities? Can you bring adequate analytical and immunological expertise to the department? Then join us as Site Microbiologist!
Since its foundation 1959, HAL Allergy grew to a well-established player in the AIT market with a highly competitive portfolio offering subcutaneous (SCIT) and sublingual (SLIT) products for pollen, house dust mites and insect venoms. Our GMP certified and state-of-the-art production facility is located in the Bio Science Park in Leiden, The Netherlands.
The Site Microbiologist is responsible for leading the site microbiology activities at the production site. You give guidance, implementation and follow-up of development projects within QC/Microbiology, including validations and CMO projects. You lead the assessment of methods and guidance of possible repair and ensure adequate microbiological expertise within the department.
- Ensure awareness of Microbiology policies and standards at sites. Monitor new microbiology requirements/regulations and modify existing policies/standards as necessary.
- Are responsible for content of Microbiology documents including Quality Standards and Quality System Procedures.
- Represent Company forums to ensure Company remains compliant with Company standards.
- Provide input and review for regulatory filings as required in order to ensure consistency.
- Provide forward thinking for Microbiology strategy in anticipation of future needs.
- Develop, review and provide training in aseptic technique to all staff.
- Provide training and oversight to aseptic processes and environmental control for fill / finish facility.
- Are responsible and lead-SME for Microbiology during audits and inspections.
- Lead in design, development and qualification of EM, PM and UM programs.
- Are responsible for trend analysis and reporting of EM, PM and UM programs.
- Ensure that the approved microbial methods and specifications used in the testing and release of products and materials meets validation acceptance criteria and are in compliance with latest pharmaceutical standards and requirements of the manufacturing authorization.
- Take a leading role in the handling of QC-related action points arising from these project groups.
- Are responsible for the HAL Allergy contamination control strategy.
We also expect you to:
- Provide Subject Matter Expertise (SME) support on all issues related to microbiology to the HAL Allergy sites. This includes review of Investigations, trending reports, responses to audit observations, microbiological contamination events during manufacturing and QC testing, etc., as required.
- Provide help during regulatory inspections at HAL Allergy sites.
- Ensure that disinfectant effectiveness studies are completed as required by HAL Allergy procedures.
- Validation of disinfection and sanitization program.
- Review change controls and validation activities that relate to (QC) microbiology, contamination control and sterility assurance.
- Lead/participate in deviation investigations related to microbiology e.g. environmental monitoring and utility excursions, sterility investigations, bioburden excursions.
- Conducting trend and out-of-trend research and leading follow-up actions arising from such research.
- Act as QC-related SME in internal and external audits.
- Education at HBO level in Microbiology.
- At least five years of relevant work experience in pharmaceutical microbiology in a pharmaceutical production environment.
- Excellent knowledge of GMP/GLP.
- Knowledge of MS-Office and software packages e.g. Labware LIMS, Q-Pulse.
- Good knowledge of the Dutch and English language, both verbally and in writing.
- You will be part of a steadily growing and dynamic biopharmaceutical company offering a great environment for self-starters.
- A culture that is characterized by entrepreneurial spirit and a friendly and helpful atmosphere. The patient’s well-being is always our top priority. This combination is the basis for an interesting and challenging environment.
- You will be working in our dynamic headquarters in Leiden, where we work on the full product pipeline from development to commercial production.
- Being part of a company that is geared towards helping people live happier and healthier lives.
- A competitive salary that matches your responsibilities and experience.
- A 13th month salary.
- 30 leave days.
- Company contribution to a pension package and heath insurance
A great place to work
HAL-Allergy is headquartered in Leiden, where our products are produced on site. We are located in the middle of the thriving and energetic Bioscience park, the largest innovation district of the Netherlands in the field of Life Sciences & Health. The central train station and the ancient city center of Leiden are just 5 minute bike ride away from our office.