At a Glance
- Tasks: Lead the re-qualification of manufacturing equipment and align SOPs with QMS requirements.
- Company: Expanding client in Belfast focused on manufacturing quality.
- Benefits: Competitive contract role with opportunities for professional growth.
- Other info: Contract role with potential for hybrid work.
- Why this job: Make a significant impact in a highly regulated industry while advancing your career.
- Qualifications: Bachelor's degree in Engineering and 8+ years in manufacturing validation.
The predicted salary is between 50000 - 65000 € per year.
Our Client in Belfast is expanding and the Program Manager for the Manufacturing Quality group tasked with integration of the QMS is looking for a Senior Manufacturing Validation Consultant. This is a full-time onsite role (occasional hybrid).
Responsibilities include:
- Plan and execute the re-qualification of existing manufacturing equipment (IQ, OQ, PQ) to meet corporate and regulatory standards.
- Align local manufacturing Standard Operating Procedures (SOPs) with the newly adopted QMS requirements.
- Perform rigorous risk assessments (e.g., FMEA) on transitioning production lines to mitigate risks during the system switchover.
- Validate manual assembly steps.
Qualifications:
- Bachelor’s degree in Engineering (Manufacturing, Mechanical, or Biomedical) or a related scientific discipline.
- ~8+ years of direct experience in manufacturing validation and quality assurance within a highly regulated industry.
- Strong working knowledge of regulatory guidelines and standards like FDA 21 CFR Part 11 & ISO13485.
PLEASE NOTE THIS IS A CONTRACT ROLE.
Technisch engineer. in Belfast employer: Oxford Global Resources
Our client in Belfast is an exceptional employer, offering a dynamic work culture that fosters innovation and collaboration within the manufacturing sector. Employees benefit from comprehensive training and development opportunities, ensuring continuous professional growth while working on cutting-edge projects that adhere to stringent regulatory standards. The company's commitment to quality and employee well-being makes it a rewarding place for those seeking meaningful contributions in a supportive environment.
StudySmarter Expert Advice🤫
We think this is how you could land Technisch engineer. in Belfast
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, especially those who work in manufacturing or quality assurance. A friendly chat can lead to insider info about job openings that aren't even advertised yet.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of regulatory guidelines and standards. Make sure you can confidently discuss FDA 21 CFR Part 11 and ISO13485, as these are crucial for the role. We want you to shine!
✨Tip Number 3
Showcase your experience with risk assessments and validation processes during interviews. Use specific examples from your past roles to demonstrate how you've successfully navigated challenges in manufacturing validation.
✨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 take the initiative to connect directly with us.
We think you need these skills to ace Technisch engineer. in Belfast
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the role of Technisch engineer. Highlight your experience in manufacturing validation and quality assurance, especially in regulated industries. We want to see how your background aligns with the job description!
Showcase Relevant Experience:When writing your application, focus on your 8+ years of experience in the field. Include specific examples of how you've executed IQ, OQ, and PQ processes, as well as any risk assessments you've performed. This will help us see your expertise in action!
Be Clear and Concise:Keep your application clear and to the point. Use bullet points where possible to make it easy for us to read through your qualifications. Remember, we’re looking for someone who can communicate effectively, so show us you can do that right from the start!
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 shows us you’re serious about joining our team!
How to prepare for a job interview at Oxford Global Resources
✨Know Your Stuff
Make sure you brush up on your knowledge of manufacturing validation and quality assurance. Familiarise yourself with regulatory guidelines like FDA 21 CFR Part 11 and ISO 13485, as these will likely come up in conversation. Being able to discuss these standards confidently will show that you're the right fit for the role.
✨Prepare for Technical Questions
Expect technical questions related to IQ, OQ, and PQ processes. We recommend reviewing your past experiences where you've executed these qualifications. Be ready to share specific examples of how you've aligned SOPs with QMS requirements and performed risk assessments like FMEA.
✨Showcase Your Problem-Solving Skills
During the interview, highlight instances where you've successfully mitigated risks during system transitions. Discuss your approach to problem-solving and how you ensure compliance while maintaining efficiency. This will demonstrate your ability to handle challenges in a highly regulated environment.
✨Ask Insightful Questions
Prepare some thoughtful questions about the company's current projects and future goals. This not only shows your interest in the role but also gives you a chance to assess if the company aligns with your career aspirations. Asking about their integration of the QMS can lead to a deeper discussion about your potential contributions.
