Vaxxas is a fast growing and scale-up stage biotech company developing a novel vaccine delivery system that safely and cost effectively amplifies vaccine efficacy. It is an advanced platform that vaccinates by applying a patch to the skin for a few seconds directly depositing vaccine amongst dense population of key immune cells.
Reporting to the Head of Clinical Operations & Supply, the Validation Manager will be responsible for all aspects of Validation. This full-time role will focus on qualification of facilities, processes, utilities, manufacturing and analytical equipment. The successful candidate will lead the validation effort, working closely with external contractors (if applicable), and internal subject matter experts.
From an operational and delivery perspective, the Validation Manager will:
- Lead the validation effort (including facilities, utilities, manufacturing and analytical equipment) and aseptic process validation.
- Provide tracking and organization of equipment validation documentation and activity and assist with software, automated systems and controls validation.
- Lead the validation activities as part of the facility design, build and qualification project by hands-on work and support from specialist contractor(s) as required.
- Support FATs, SATs, IQ/OQ as appropriate of plant and equipment, reviewing documentation and advising team members to deliver best practice.
- Key contributor in the project team to validate the manufacturing unit, working full-time on design, build and qualification activities.
- Work effectively and supportively with other project team members to deliver the GMP manufacturing facility in accordance with the programme.
- Participate in and respond to inspections by Regulatory Authorities representing the validation function.
- Participate in continuous improvement in the manufacturing facility to enable production to be conducted effectively and efficiently.
- Establish and maintain strong relationships with cross functional departments including Manufacturing, Quality, Engineering and Regulatory groups
To be successful in this role you will have experience as a Validation Manager role within a similar company. You will have experience across the following:
- Bachelor’s degree in Biological Sciences, Engineering; Advanced degree is considered an asset.
- Knowledge of system validation life-cycle concept.
- Experience in writing Validation Master plans, Risk Assessments (pFMEA, cross-contamination) and other high level project documentation.
- Develop and implement protocols and procedures that embody best practices in biologics manufacturing (cGMP, QbD)
- Experience in biologics or pharmaceutical industry with a background in facility, services, equipment, computer software, operator and aseptic validation.
- Working knowledge of GMP, and with a deep understanding of validation of cleanroom manufacturing environments and related equipment.
- Able to generate GMP documentation to a high standard and relating to validation including policies, SOPs, protocols and reports.
- Strong competencies in planning, project management, and organization with the ability to lead multiple activities and resources while maintaining a focus on quality.
- Solid analytical and strategic capabilities combined with business acumen and a demonstrated track record of work ethic, integrity, and professional conduct and appearance.
- Exceptional interpersonal and leadership skills to effectively communicate and build working relationships with a broad spectrum of audiences at all organizational levels.
- An entrepreneurial, innovative, energetic, hands-on, team oriented, and customer focused, attitude and approach.
- Ability and strong desire to work in a dynamic “scale-up” environment and be able travel from time to time domestically and/or internationally.
- Manage priorities and tight timeframes - Self-motivation in achieving goals and a positive mindset towards this.
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) both in Word format by selecting the “apply now” function.
Confidential enquiries can be made to Peter Starling, Client Partner on 07 3305 5830 or 0433 422 518.