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For Companies 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.
- Why this job: Make a real difference in the future of medicine while developing your engineering skills.
- Qualifications: Experience in GMP environments and strong communication skills required.
- Other info: Dynamic team with a focus on safety, quality, and continuous improvement.
The predicted salary is between 36000 - 60000 £ per year.
Your mission
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
Job Description
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 procedures
- 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 in a timely manner and in a RFT state that complies 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 Preventive Maintenance and Calibration timeliness
- Timely response to unplanned maintenance requirements
- Timely completion of all Safety and Quality commitments
Key Job Competencies
- 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 executing documentation as SME
- Responsible for fronting as SME in regulatory inspections regarding Calibration and Maintenance
Job Background
- Experience performing and/or supervising maintenance in GMP operational facilities
- Experience with Computerised Maintenance Management Systems
- HNC / HND / Degree level education in a relevant Engineering discipline
- Excellent standard of written and verbal communication in the English language
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Calibration & Maintenance Engineer employer: Meiragtx
Contact Detail:
Meiragtx Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Calibration & Maintenance Engineer
✨Tip Number 1
Network like a pro! Reach out to professionals in the calibration and maintenance field on LinkedIn. Join relevant groups, participate in discussions, and don’t hesitate to ask for informational interviews. You never know who might have the inside scoop on job openings!
✨Tip Number 2
Prepare for interviews by brushing up on your technical knowledge. Be ready to discuss your experience with GMP, calibration techniques, and maintenance strategies. We recommend practising common interview questions related to your expertise to boost your confidence.
✨Tip Number 3
Showcase your skills through real-life examples. When you get the chance to interview, share specific instances where you improved processes or solved problems in previous roles. This will demonstrate your subject matter expertise and how you can add value to the team.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search. So, get your CV ready and hit that apply button!
We think you need these skills to ace Calibration & Maintenance Engineer
Some tips for your application 🫡
Show Your Expertise: Make sure to highlight your subject matter expertise in calibration and maintenance. We want to see how your technical knowledge aligns with our needs, so don’t hold back on showcasing your experience in GMP environments!
Tailor Your Documents: When applying, tailor your CV and cover letter to reflect the specific requirements mentioned in the job description. We love it when candidates take the time to connect their skills and experiences directly to what we’re looking for.
Be Clear and Concise: Keep your application clear and to the point. We appreciate well-structured documents that are easy to read. Use bullet points where necessary to make your key achievements stand out!
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy to do!
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.
✨Prepare for Technical Questions
Expect to face technical questions related to calibration, metrology, and maintenance techniques. Review key concepts and be prepared to explain your approach to troubleshooting and executing maintenance activities. This will demonstrate your subject matter expertise and problem-solving skills.
✨Showcase Your Documentation Skills
Since documentation is crucial in this role, be ready to talk about your experience with creating and reviewing technical documents. Highlight any experience you have with Computerised Maintenance Management Systems (CMMS) and how you've ensured compliance with documentation standards in previous roles.
✨Emphasise Continuous Improvement
Be prepared to discuss how you've contributed to continuous improvement initiatives in your previous positions. Share specific examples of how you've identified areas for improvement and implemented changes that enhanced safety, quality, or efficiency in maintenance and calibration processes.
