At a Glance
- Tasks: Lead maintenance and calibration activities for cutting-edge gene therapy products.
- Company: Join a pioneering biotech firm dedicated to innovative healthcare solutions.
- Benefits: Attractive salary, health perks, flexible working, and growth opportunities.
- Other info: Dynamic team culture with a focus on continuous improvement and safety.
- Why this job: Be a key player in ensuring the quality of life-changing therapies.
- Qualifications: Experience in GMP environments and strong engineering background required.
The predicted salary is between 40000 - 50000 € per year.
Provide subject matter expertise in the establishment, improvement, troubleshooting and execution of maintenance and calibration activities, to ensure that assets required for the GMP manufacture and testing of gene therapy products are available and fit for use in line with business requirements.
Major Activities
- SME for Calibration, Metrology and Planned Maintenance techniques and requirements.
- Responsible for defining the optimum approach for maintenance and calibration of GMP assets, based on technical knowledge and cGMP requirements/best practice.
- Responsible for coordinating technical oversight and approval of calibration and maintenance technical documentation (internal and external) throughout the equipment lifecycle.
- Responsible for the coordination and supervision of maintenance and calibration activities by internal and external resources in accordance with the CMMS.
- Responsible for creation, review and approval of maintenance and calibration technical documents for new equipment introduction and throughout the equipment lifecycle.
- Responsible for technical input into new/revised Service Level Agreements with 3rd parties for calibration and maintenance.
- Responsible for authoring and maintaining Technical Standards relating to calibration and maintenance, in partnership with other Calibration & Maintenance Engineers.
- Responsible for demonstrating a high standard of health and safety behaviour and practice, ensuring that all EHS commitments are delivered on time in full.
- Responsible for supporting a state of Inspection Readiness every day within the Facilities and Maintenance Engineering team, and for supporting the successful preparation and fronting of Regulatory Inspections and Audits.
- Manage Quality processes including Risk Assessments, Change Controls, CAPAs and Deviations as per the site Quality Management System, including as lead for deviations relating to maintenance as-found failures.
- Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedure.
- Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken.
- Responsible for ensuring that any GMP documentation assigned e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions is closed timely and in a RFT state that comply with MeiraGTx procedures including Health and safety and GMP.
- Responsible for identifying, collaborating and delivering continuous improvements within the Facilities & Maintenance team to improve safety, quality, service and cost.
Key Performance Indicators
- Planned Preventative Maintenance and Calibration timelines.
- Timely response to unplanned maintenance requirement.
- Timely completion of all Safety and Quality commitments.
- Subject Matter Expertise in Calibration, Maintenance and/or Metrology.
Job Responsibilities
- Supervision of internal and external personnel performing planned maintenance.
- Responsible for approving master documentation and executed documentation.
- Responsible to front as SME in regulatory inspections regarding Calibration and Maintenance.
Job Background
- Experience performing and/or supervising maintenance in GMP operational facilities.
- Experience with operation, administration and development of Computerised Maintenance Management Systems including developing workflows, job plans, calibration management systems.
- HNC / HND / Degree level education in relevant Engineering discipline.
- Excellent standard of written and verbal communication in English language.
Calibration and Maintenance Engineer in London employer: Meiragtx
As a Calibration and Maintenance Engineer at our company, you will join a dynamic team dedicated to ensuring the highest standards of quality and safety in the manufacture of gene therapy products. We pride ourselves on fostering a collaborative work culture that encourages continuous learning and professional development, offering robust training programmes and opportunities for career advancement. Located in a state-of-the-art facility, we provide a supportive environment where your expertise will directly contribute to groundbreaking advancements in healthcare.
StudySmarter Expert Advice🤫
We think this is how you could land Calibration and Maintenance Engineer in London
✨Tip Number 1
Network like a pro! Reach out to professionals in the calibration and maintenance field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your technical knowledge and understanding of GMP requirements. We recommend practising common interview questions related to calibration and maintenance to show you’re the SME they need!
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and expertise. Check out our website for openings that match your skills in calibration and maintenance – we’ve got some great opportunities waiting for you!
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. We believe showing appreciation for the opportunity can set you apart from other candidates.
We think you need these skills to ace Calibration and Maintenance Engineer in London
Some tips for your application 🫡
Show Your Expertise:Make sure to highlight your subject matter expertise in calibration and maintenance. Use specific examples from your experience that demonstrate your knowledge of GMP requirements and best practices. We want to see how you can bring value to our team!
Tailor Your Application:Don’t just send a generic application! Tailor your CV and cover letter to match the job description. Mention your experience with Computerised Maintenance Management Systems and how it relates to the role. This shows us you’ve done your homework and are genuinely interested.
Be Clear and Concise:When writing your application, keep it clear and concise. Avoid jargon unless it’s relevant to the role. We appreciate straightforward communication, so make sure your skills and experiences shine through without unnecessary fluff.
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’re considered for the role. Plus, it gives you a chance to explore more about what we do at StudySmarter!
How to prepare for a job interview at Meiragtx
✨Know Your GMP Inside Out
Make sure you brush up on Good Manufacturing Practices (GMP) and how they relate to calibration and maintenance. Be ready to discuss specific examples from your past experience where you've applied these principles, as this will show your expertise and understanding of the industry.
✨Showcase Your Technical Skills
Prepare to talk about your experience with Computerised Maintenance Management Systems (CMMS). Highlight any workflows or job plans you've developed, and be ready to explain how these have improved efficiency or compliance in previous roles.
✨Demonstrate Your Problem-Solving Abilities
Think of a few scenarios where you've had to troubleshoot maintenance issues or improve calibration processes. Use the STAR method (Situation, Task, Action, Result) to structure your answers, showcasing your analytical skills and ability to work under pressure.
✨Be Ready for Regulatory Questions
Since you'll be fronting as a Subject Matter Expert during regulatory inspections, prepare for questions related to compliance and documentation. Familiarise yourself with common inspection scenarios and be ready to discuss how you ensure inspection readiness in your current or previous roles.
