Quality Assurance & Control (Science & Technology) Full time Join the forefront of innovation as a Senior Validation Specialist at Vaxxas, ensuring the highest quality standards for next-generation vaccine technologies. Overview This is a combined technical and supervisory/mentoring role within the Quality team. The Senior Validation Specialist will review risk assessments, user requirements, protocols and reports for validation activities associated within facilities, utilities and equipment. This role will also support visually communicating completion vs expected timelines for the facilities validation team.
Duties & Responsibilities Support site commissioning and qualification projects in the pre and post execution approval of validation activities.Assist in impact assessment and reporting of any discrepancies and deviations affecting site facilities and utilities and provide guidance on upgrade plans from a validation perspective.Ensure validation activities operate within the accepted practices and quality standards to meet the performance objectives of the department.Support with validation documentation drafting and approval.Assist in delivering team key objectives and goals.Qualifications Bachelor's degree in Engineering (Mechanical / Electrical or similar) or Science in a relevant discipline - completion of chemistry/biochemistry/microbiology/pharmacy science degree/s (preferred).5+ years' experience in validation.Desired experience and skills PIC/S Code of GMP including Annex 1, Annex 11 Computerised Systems and Annex 15 Qualification and Validation; ideally also Annex 13 – Investigational Medicinal Products.Pharmaceutical validation requirements including facility, utilities, equipment, personnel, computer software, cleaning, process and shipping validation.Knowledge of 21CFR Part 11 Electronic Records; Electronic Signatures.Experience with validation documentation including RA, URS, DQ, CS, IQ, OQ and PQ.Sound understanding of CSV requirements including GAMP5 and 21CFR part 11.Knowledge of Pharmaceutical Quality Management Systems, medical device standards and validation lifecycles.Good documentation practices and data integrity requirements.Effective time/resource management with the ability to prioritise and ensure deadlines are met.Mentoring and influencing other areas of an organisation.About Vaxxas Vaxxas is a privately held, clinical stage biotechnology company focused on enhancing the performance of existing and next-generation vaccines with its proprietary high-density microarray patch (HD-MAP). Vaxxas is targeting initial applications in infectious disease and oncology.
The company's innovative, needle-free technology can eliminate or significantly reduce the need for vaccine refrigeration during storage and transportation, easing the resource and logistics burden of maintaining the vaccine cold chain.
In addition to a Phase I clinical study of a COVID-19 vaccine candidate, Vaxxas is performing demonstration work in preparation for clinical evaluation under contract with the United States Biomedical Advanced Research and Development Authority (BARDA) on pandemic vaccination solutions, among multiple other clinical and preclinical programs.
The company has forged collaborations with leading global organisations in vaccine commercialisation, including Merck/MSD, CEPI, the World Health Organization (WHO), and the Gates Foundation.
Learn more at www.vaxxas.com If you are looking for a role to unlock your potential as a Senior Validation Specialist, we want to hear from you!
To be considered, please submit your Resume and a cover letter (outlining your core capability for the role, demonstrated experience of how you have delivered outcomes and why this role is of interest) by selecting the "apply for this job" function. You will be contacted directly if your application is successful.
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