At a Glance
- Tasks: Execute re-qualification of manufacturing equipment and align SOPs with QMS requirements.
- Company: Expanding client in Belfast focused on manufacturing quality.
- Benefits: Contract role with competitive pay and potential for hybrid work.
- Other info: Opportunity to work in a highly regulated industry with strong career prospects.
- Why this job: Join a dynamic team and ensure high-quality standards in manufacturing.
- Qualifications: Bachelor's degree in Engineering and 8+ years in manufacturing validation.
The predicted salary is between 40000 - 50000 € 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.
Parttime Engineer in Belfast employer: Oxford Global Resources
Our client in Belfast is an exceptional employer, offering a dynamic work environment that fosters innovation and collaboration. With a strong commitment to employee development, they provide ample opportunities for growth and advancement within the manufacturing sector. The company's focus on quality assurance and regulatory compliance ensures that employees are engaged in meaningful work that contributes to the success of the organisation and the industry as a whole.
StudySmarter Expert Advice🤫
We think this is how you could land Parttime Engineer in Belfast
✨Tip Number 1
Network like a pro! Reach out to your connections in the engineering and manufacturing sectors. Attend industry events or webinars to meet potential employers and get your name out there.
✨Tip Number 2
Prepare for interviews by brushing up on your technical knowledge and understanding of regulatory standards. Be ready to discuss how your experience aligns with the job requirements, especially around QMS and validation processes.
✨Tip Number 3
Showcase your problem-solving skills! During interviews, share specific examples of how you've tackled challenges in manufacturing validation. This will demonstrate your hands-on experience and ability to adapt.
✨Tip Number 4
Don't forget to apply through our website! We make it easy for you to find roles that match your skills and experience. Plus, it shows you're serious about joining our team!
We think you need these skills to ace Parttime Engineer in Belfast
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the role of Part-time Engineer. Highlight your experience in manufacturing validation and quality assurance, especially any work with regulatory standards like FDA 21 CFR Part 11 & ISO13485. We want to see how your background aligns with what our client is looking for!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for this role. Mention specific projects or experiences that relate to the job description, especially around re-qualification of manufacturing equipment and risk assessments. We love a good story!
Showcase Relevant Skills:Don’t forget to showcase your skills that are relevant to the position. If you have experience with IQ, OQ, PQ processes or aligning SOPs with QMS requirements, make sure to mention them. We’re looking for candidates who can hit the ground running!
Apply Through Our Website:We encourage you to apply through our website for a smoother application process. It helps us keep track of 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 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.
✨Showcase Your Experience
Prepare to discuss your past experiences in detail, especially those that relate to re-qualification of manufacturing equipment and risk assessments. Use specific examples to demonstrate how you've successfully navigated challenges in a regulated environment.
✨Align with Their Needs
Understand the company's current QMS integration goals and think about how your skills can help them achieve these. Be ready to suggest ways you can align local SOPs with their new requirements during the interview.
✨Ask Smart Questions
Prepare insightful questions about the role and the company’s future plans. This shows your genuine interest and helps you gauge if the company is the right fit for you. Think about asking how they handle transitions in production lines and what challenges they foresee.
