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- Tasks: Lead sterility assurance efforts and ensure compliance in manufacturing operations.
- Company: Join CSL Seqirus, a global leader in influenza vaccine production.
- Benefits: Enjoy competitive benefits, including health support and professional development opportunities.
- Why this job: Make a real impact in public health while advancing your career in a dynamic environment.
- Qualifications: 5+ years of GMP experience and a degree in Microbiology or related field.
- Other info: Be part of a diverse team that values inclusion and innovation.
The predicted salary is between 36000 - 60000 £ per year.
Working at the Liverpool site as part of the Global SA team under general direction from the Snr Manager of Sterility Assurance, this candidate is to provide sterility assurance support for the Seqirus Liverpool and relevant CMO Sites. They will support (and deputise for) the Snr Manager and will focus their efforts to ensure that from an aseptic perspective, the day to day manufacturing operation runs in accordance with its validated status, all SOPs, the Quality manual and Good Manufacturing Practice.
They will also advocate/lead necessary change management processes, participate in complex manufacturing investigations including product impact assessment and maintain their own knowledge/expertise to be recognised as a site SME and act as such during regulatory inspections. They will participate in the design and delivery of training programmes. They will be competent to author product impact assessments and working closely with the site QA team assist in batch disposition decisions.
Under the guidance of the Sr Manager Sterility Assurance, to collaborate with the manufacturing leadership teams and to spend time in manufacturing areas and provide broad consultation/support for sterility assurance issues both in LVP as well as 3rd party manufacturing facilities that work on behalf of Liverpool. Management of complex deviation investigations (e.g. sterility failure, breach of the sterile boundary) to support appropriate decision making. A recognized subject matter expert and able to perform product impact assessments for sterility assurance events. Work with Sr Manager Sterility Assurance and Frontline QA to support batch disposition decisions.
Actively coaches and supports the development of the Sterility Assurance Specialist associate through a combination of direct coaching, partnering and supporting on stretch assignments and facilitating developmental sharing. Shares accountability for supporting site level training and EM reporting with the Sterility Assurance Specialist to facilitate time spent on stretch projects. Builds bridges and helps teams develop collaboration by working with heads of manufacturing, engineer and MS&T to implement engineering controls to reduce the likelihood of events (e.g. utilization of closed system processing). Manages large projects or processes with limited support from manager.
Maintaining own knowledge of changes in Regulatory authority requirements and expectations as well as new available technologies. To escalate emerging trends or changes in site performance to Sr Sterility Assurance manager and key stakeholders, through 1:1 communication and appropriate site and Global forums. To ensure that operational areas are fully aware of results obtained and trends that are developing and ensuring that they have the opportunity to contribute to root cause investigations. Provide communication to global network to ensure that corrective actions are harmonized across the entirety of the Seqirus network.
Implement the microbial assurance aspects of the Quality System, maintaining the sterility assurance oversight plan as part of the site Quality plan. Ensures compliance with established internal specifications, standard operating procedures (SOP) and government regulations. Responds to questions from authorities (TGA, FDA, etc.) to ensure timely product release. Serve as the subject matter expert for sterility assurance regulatory submissions and regulatory inspections. Help to maintain and deliver a site-specific sterility assurance training program aligned with regulatory requirements and harmonized with other facilities in the Seqirus network. Provide ongoing coaching of manufacturing associates and quality assurance staff as appropriate, and Induction training covering Basic Microbiology and Aseptic operator training. Provide consultation and ownership on aseptic related changes to manufacturing systems and process. For example, implementation of a sterile filtration step or changes in bioburden action limits.
Education Requirements
Bachelors degree in a related discipline (Microbiology, Biochemistry, Pharmaceutical Sciences). Advanced degree (Masters/Ph.D) preferred.
Experience Requirements
5+ years' GMP experience in pharmaceutical/biotech/regulated industry Evidence of Risk Based Decision making/Quality Risk Management. Relevant experience of Aseptic Manufacturing/Oversight or Sterility Assurance/Quality role.
This position is also available 12 month secondment opportunity for internal candidates.
Sterility Assurance Manager in Liverpool employer: CSL Seqirus
Contact Detail:
CSL Seqirus Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Sterility Assurance Manager in Liverpool
✨Tip Number 1
Network like a pro! Reach out to current employees at CSL Seqirus on LinkedIn or other platforms. Ask them about their experiences and any tips they might have for landing the Sterility Assurance Manager role.
✨Tip Number 2
Prepare for the interview by brushing up on your knowledge of GMP and sterility assurance practices. Be ready to discuss how you’ve handled complex deviation investigations in the past—real-life examples will make you stand out!
✨Tip Number 3
Show your passion for continuous learning! Mention any recent courses or certifications related to microbiology or aseptic processes. This will demonstrate your commitment to staying updated in the field.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re serious about joining the CSL Seqirus team.
We think you need these skills to ace Sterility Assurance Manager in Liverpool
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter to highlight your experience in sterility assurance and GMP. We want to see how your skills align with the role, so don’t hold back on showcasing your relevant achievements!
Showcase Your Expertise: As a potential subject matter expert, it’s crucial to demonstrate your knowledge in aseptic manufacturing and regulatory compliance. Use specific examples from your past roles to illustrate your expertise and how you’ve contributed to quality assurance.
Be Clear and Concise: When writing your application, keep it straightforward and to the point. We appreciate clarity, so avoid jargon and ensure your key points stand out. This will help us quickly see why you’re a great fit for the team!
Apply Through Our Website: We encourage you to submit your application directly through our website. It’s the best way to ensure your application gets into the right hands and shows us you’re serious about joining our team at CSL Seqirus!
How to prepare for a job interview at CSL Seqirus
✨Know Your Stuff
Make sure you brush up on your knowledge of sterility assurance and Good Manufacturing Practice (GMP). Be prepared to discuss specific examples from your past experience that demonstrate your expertise in aseptic manufacturing and how you've handled complex deviation investigations.
✨Show Your Leadership Skills
Since this role involves coaching and supporting others, think of instances where you've led a team or mentored colleagues. Be ready to share how you’ve facilitated training programmes or contributed to change management processes in your previous roles.
✨Be Ready for Technical Questions
Expect questions about regulatory requirements and how you would respond to authorities like the TGA or FDA. Familiarise yourself with recent changes in regulations and be prepared to discuss how these might impact sterility assurance practices.
✨Demonstrate Collaboration
This position requires working closely with various teams. Think of examples where you've successfully collaborated with manufacturing leadership or quality assurance teams. Highlight how you’ve built bridges and fostered teamwork to achieve common goals.