At a Glance
- Tasks: Manage QC method validation and troubleshoot testing methodologies in a dynamic lab environment.
- Company: Join Seqirus, a leader in the pharmaceutical industry with a focus on innovation.
- Benefits: Gain valuable experience, competitive pay, and opportunities for professional growth.
- Other info: 12-month fixed-term contract with potential for career advancement.
- Why this job: Make a real impact in pharmaceuticals while working with cutting-edge analytical technologies.
- Qualifications: Bachelor’s degree in a scientific field and experience in method development and validation.
The predicted salary is between 35000 - 45000 € per year.
Reporting to the Head of Analytical Science and Technology at Seqirus Liverpool, the role is accountable for QC method validation lifecycle management and method standardisation/robustness. The validation specialist is an SME in testing methodology, able to troubleshoot technical issues, develop current and existing methods, and stay current with the latest analytical testing technologies. The role requires the execution of intra-site method transfers and SME input into regulatory filings and audits alongside validation lifecycle management. Routine testing support for technical development and MS+T pilot plant manufacturing processes is required in support of critical manufacturing process parameter activities and new strain introduction as required.
Responsibilities
- Maintain the compliant status of QC method validation lifecycle
- Troubleshoot technical challenges with QC test methods
- Execute method standardisation and robustness program
- Develop current and new test methods, engaging with the latest testing technologies
- Execute intra-site method transfers and provide SME input into regulatory filings and audits
- Support testing of critical process parameter activities and maintain the facility, including:
- Instrument maintenance and calibration
- Reporting of results
- Reagent and standard qualification
- HSE risk assessment completion, review and adherence
- Archiving of laboratory documentation
- Ordering of reagents and consumables
- Maintenance of AS+T sample and reagent stores
- Ensuring a clean and safe workplace for all associates
- Participation in quality risk assessments
Education Requirements
Bachelor’s degree in a relevant scientific discipline (Chemistry, Biochemistry, Microbiology preferred).
Experience Requirements
- Experience working in pharmaceuticals, particularly biologics
- Experience in method development, method validation and method transfers
- Experience in assay lifecycle management and regulatory submission
- Experience in quality control testing techniques and industry practices
- Planning and executing investigative testing in support of root-cause analysis
- Proven time-management skills for planning and scheduling of work
- Proven communication skills both written and verbal
- Desirable: experience of process or product characterization using a variety of orthogonal methods
This position is available as a 12-month secondment opportunity.
Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please refer to the accessibility statement.
AS&T Validation Specialist (12 month fixed-term contract) employer: CSL
Seqirus Liverpool is an exceptional employer that prioritises employee growth and development within a collaborative and innovative work culture. As an AS&T Validation Specialist, you will benefit from engaging with cutting-edge analytical technologies while contributing to critical manufacturing processes in a supportive environment that values compliance and safety. With opportunities for professional advancement and a commitment to diversity and inclusion, Seqirus offers a rewarding career path for those seeking meaningful contributions in the pharmaceutical industry.
StudySmarter Expert Advice🤫
We think this is how you could land AS&T Validation Specialist (12 month fixed-term contract)
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, especially those at Seqirus or similar companies. A friendly chat can open doors and give you insights that job descriptions just can't.
✨Tip Number 2
Prepare for interviews by brushing up on your technical knowledge. Be ready to discuss QC method validation and troubleshooting techniques. Show us you know your stuff, and we’ll be impressed!
✨Tip Number 3
Don’t forget to showcase your soft skills! Communication is key in this role, so practice articulating your thoughts clearly. We want to see how you can collaborate and contribute to the team.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows us you’re genuinely interested in being part of our team at StudySmarter.
We think you need these skills to ace AS&T Validation Specialist (12 month fixed-term contract)
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experiences that match the job description. Highlight your experience in QC method validation and any relevant technical challenges you've tackled. We want to see how you fit into our world!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about the role and how your background in pharmaceuticals makes you a great fit. We love seeing enthusiasm and a personal touch!
Showcase Your Technical Skills:Since this role involves troubleshooting and method development, be sure to mention specific technologies or methodologies you’ve worked with. We’re looking for someone who can hit the ground running, so let us know what you bring to the table!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates. Plus, it’s super easy – just a few clicks and you’re done!
How to prepare for a job interview at CSL
✨Know Your Methods Inside Out
Make sure you’re well-versed in QC method validation and the latest analytical testing technologies. Brush up on your knowledge of method development and validation processes, as you'll likely be asked to discuss your experience and how you've tackled technical challenges in the past.
✨Showcase Your Troubleshooting Skills
Prepare examples of how you've successfully resolved technical issues with QC test methods. Be ready to explain your thought process and the steps you took to troubleshoot problems, as this will demonstrate your expertise and problem-solving abilities.
✨Familiarise Yourself with Regulatory Standards
Since the role involves providing SME input into regulatory filings and audits, it’s crucial to understand the relevant regulations and compliance requirements. Research the specific guidelines that apply to the pharmaceutical industry, particularly in biologics, so you can speak confidently about your experience.
✨Emphasise Team Collaboration
This position requires working closely with various teams, so highlight your communication skills and any experience you have in collaborative projects. Be prepared to discuss how you’ve contributed to team success in previous roles, especially in relation to method transfers and quality risk assessments.
