Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
About Us:
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Location/Division
Our Brisbane site - Patheon Pharma Services, is a multi-product, biopharmaceutical site with development and manufacturing facilities for pharmaceutical products for clinical trials (Phase I, II and III).
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About the Role:
You will set the strategy, standard methodology, and policies for contamination control for the site. You possess strong understanding of microbiology and contamination control requirements for biological products and biomanufacturing processes. Being the subject matter expert, you are confident to drive strong collaboration with internal and global teams to ensure appropriate actions are taken to prevent contamination of product and facility, and drive compliance to regulations.
What You'll Do:
- Develop, own, and collaborate to build the contamination control strategy ensuring regulation compliance and bringing to bear industry expertise and ongoing updates for regulators and clients
- Lead all aspects of the efficiency of the Environmental Monitoring system including the trend analysis, identify any weaknesses and initiate any required improvements
- Assist with regulatory inspections and client audits, including as a front room for SME.
- Oversee and support the microbial control strategy, approach and implementation for PPQ and commercial production
- Assure adequate trend analyses are carried out from the environmental monitoring data for viable and non-viable particles
- Report status of and promote Contamination Control within the Senior Leadership Team
- Lead, mentor and empower members of the environmental action committee
- Provide technical input into relevant quality investigations (e.g., deviation, CAPA atypical, Out of Specification and Out of Trend investigations to ensure swift resolution and recommending appropriate corrections
- Implement practical application of the Quality System, Change Control, Deviations, CAPA, OOS and OOT, Document Management, related to the Quality Control Department
Keys to Success:
Education:
- Bachelor of Science (Biotechnology, Chemistry, or closely related degree).
- Post Graduate qualifications (highly advantageous)
Knowledge, Skills & Experience:
- At least 10 - 15 years' industry work experience within the biopharmaceutical and/or pharmaceutical sector aligned to microbiology fields
- Demonstrated experience leading teams to develop and implement core strategies, policies and processes
- Strong working knowledge in cGMP policies and practices
- Established experience in microbiology theory and technical expertise with microbiological analysis
- Experience with regulatory inspection practices through direct agency engagements
- Ability to work optimally in a highly multifaceted environment with a wide diversity of people and perspectives
- Ability and effectively to work on multiple tasks and projects simultaneously with an approach that values continuous improvement
- Good knowledge of Microsoft applications (Excel, Word, Outlook, PowerPoint) and Smartsheets
Benefits
Join our team and take advantage of these great benefits! Apply now to learn more about the full range of benefits we offer.
- Health & Wellbeing: Join a company that prioritizes your health & wellbeing with comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues.
- Flexibility: Balance your work and personal life with flexible arrangements.
- Extra Leave: Benefit from generous leave policies, including the option to purchase additional leave, paid birthday leave, and company paid parental leave.
- Charitable Giving & Volunteering: Make an impact with paid volunteer time to support non-profit organizations that matter to you.
- Learning & Development: Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development.
Thermo Fisher Scientific Australia WGEA Employer of Choice for Gender Equality
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.