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- Tasks: Join our team as a Production Operator, executing vital production processes and ensuring compliance.
- Company: Be part of a leading biotech firm revolutionising cancer treatment with innovative CAR-T cell therapies.
- Benefits: Enjoy a permanent role with shift flexibility and the chance to work in a cutting-edge environment.
- Why this job: Make a real impact in healthcare while working in a collaborative and dynamic team culture.
- Qualifications: Minimum 2 years of GMP manufacturing cleanroom experience required; familiarity with Lean Six Sigma is a plus.
- Other info: This role involves weekend shifts and offers opportunities for mentoring and professional growth.
The predicted salary is between 30000 - 42000 £ per year.
Are you an experienced Production Operator interested in joining our biotech client that is leading the way in developing innovative CAR-T cell therapies for cancer treatment? Our client is looking for a highly motivated Operator II to join their GMP manufacturing team. This is a shift-based role that involves weekends and shifts that fall within the operating hours of 6AM-10PM. You will play a key role in ensuring the production of high-quality cell-based products while maintaining compliance with GMP regulations, safety standards and company procedures.
Responsibilities:
- Execute production processes and operate associated equipment in line with GMP and GDP requirements.
- Maintain cleanroom environments through sterile room maintenance, hydrogen peroxide vapour gassing, and environmental monitoring (EM).
- Conduct raw material transfers, particulate cleaning and disinfection, material receipt, and drug product shipment.
- Accurately complete documentation and data entry, ensuring compliance with regulatory standards.
- Perform cell culture activities including sampling, counting, washing, activation, feeding, harvesting, and magnetic enrichment/depletion (MACS).
- Carry out aseptic manipulations in Grade A environments and meet associated BROTH qualification (OAQ) standards.
- Support batch review execution and collaborate with cross-functional teams to ensure smooth workflow.
- Lead or support operational deviations, process risk assessments, and continuous improvement (CI) initiatives.
- Assist in the authoring and revision of SOPs, SWIs, and risk assessments to maintain process efficiency and compliance.
- Provide guidance and mentoring to junior team members, supporting their training and development.
- Follow all SOPs/SWI applicable & in which the individual has been trained and always act in compliance with GMP & to proactively raise any issues.
Required Experience:
- Minimum 2 years GMP manufacturing cleanroom experience.
- Exposure to high performance/stress conditioned work.
- Demonstrate detailed understanding of GxP / sterile / ATMP production.
- Demonstrate proficiency in environmental, health & safety requirements.
- Ability to follow detailed instructions and make quality-critical decisions.
Preferred Experience:
- Experience working in a shift-based environment.
- Familiarity with problem-solving methodologies like Lean Six Sigma.
This role offers an exciting opportunity to be part of an innovative biotech company, contributing to the manufacture of next-generation cell-based therapies. If you're passionate about GMP manufacturing and eager to make a difference, we’d love to hear from you!
Production Operator employer: Skills Alliance
Contact Detail:
Skills Alliance Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Production Operator
✨Tip Number 1
Familiarise yourself with GMP regulations and standards, as this role heavily relies on compliance. Understanding these guidelines will not only help you in the interview but also demonstrate your commitment to quality and safety.
✨Tip Number 2
Highlight any experience you have in cleanroom environments or with cell culture activities. Be prepared to discuss specific examples of how you've maintained sterile conditions or handled raw materials in previous roles.
✨Tip Number 3
Showcase your ability to work in a shift-based environment. If you have prior experience in similar settings, mention how you managed your time and maintained productivity during different shifts.
✨Tip Number 4
Prepare to discuss any continuous improvement initiatives you've been involved in, especially if they relate to Lean Six Sigma methodologies. This will demonstrate your proactive approach to enhancing processes and efficiency.
We think you need these skills to ace Production Operator
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly read the job description for the Production Operator position. Understand the key responsibilities and required experience, especially the importance of GMP compliance and cleanroom protocols.
Tailor Your CV: Customise your CV to highlight relevant experience in GMP manufacturing and cleanroom environments. Emphasise any specific skills related to cell culture activities and your ability to follow detailed instructions.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for biotech and your motivation to contribute to innovative CAR-T cell therapies. Mention your experience with problem-solving methodologies like Lean Six Sigma if applicable.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any errors or inconsistencies. Ensure that all information is accurate and that your application reflects your best self.
How to prepare for a job interview at Skills Alliance
✨Know Your GMP Regulations
Familiarise yourself with Good Manufacturing Practice (GMP) regulations and how they apply to the production of cell-based therapies. Be prepared to discuss your previous experiences in maintaining compliance and how you ensure quality in your work.
✨Demonstrate Technical Skills
Highlight your technical skills related to cleanroom environments and aseptic techniques. Be ready to provide specific examples of your experience with cell culture activities and any relevant equipment you've operated.
✨Showcase Problem-Solving Abilities
Since the role may involve operational deviations and process risk assessments, be prepared to discuss how you've approached problem-solving in high-pressure situations. Mention any methodologies like Lean Six Sigma that you are familiar with.
✨Emphasise Team Collaboration
This position requires collaboration with cross-functional teams. Share examples of how you've worked effectively within a team, mentored junior members, or contributed to continuous improvement initiatives in your previous roles.
