At a Glance
- Tasks: Plan and execute re-qualification of manufacturing equipment to meet standards.
- Company: Expanding client in Belfast with a focus on quality manufacturing.
- Benefits: Full-time contract role with potential for hybrid work and valuable experience.
- Other info: Contract role lasting 18 months to 2 years with career growth opportunities.
- Why this job: Join a dynamic team and make a real impact in manufacturing validation.
- Qualifications: Bachelor's degree in Engineering and 8+ years in manufacturing validation required.
The predicted salary is between 50000 - 60000 € 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) with a length of assignment of 18 months to 2 years, starting at the end of June.
Key Responsibilities:
- Plan and execute the re-qualification of existing manufacturing equipment (IQ, OQ, PQ) to meet corporate and regulatory standards.
- Assess and update Process Validation Master Plans (PVMP) to reflect updates.
- 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.
- Harmonise legacy equipment calibration schedules with parent QMS master plans.
- Validate manual assembly steps.
Background:
- 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.
- Understanding of metrology, calibration tolerances, and NIST-traceable standards.
PLEASE NOTE THIS IS A CONTRACT ROLE.
Validation 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 within the Manufacturing Quality group. With a strong commitment to employee development, they provide opportunities for growth through hands-on experience in a highly regulated industry, while also promoting a culture of safety and quality. The unique location in Belfast not only offers a vibrant city life but also access to a supportive community, making it an ideal place for professionals seeking meaningful and rewarding careers.
StudySmarter Expert Advice🤫
We think this is how you could land Validation Engineer in Belfast
✨Tip Number 1
Network like a pro! Reach out to folks in the industry on LinkedIn or at local meetups. We all know that sometimes it’s not just what you know, but who you know that can help you land that Validation Engineer role.
✨Tip Number 2
Prepare for those interviews by brushing up on your technical knowledge and regulatory standards. We recommend practising common interview questions related to manufacturing validation so you can showcase your expertise confidently.
✨Tip Number 3
Don’t forget to tailor your approach! When you’re applying through our website, make sure to highlight your relevant experience in manufacturing validation and quality assurance. We want to see how you fit into the role!
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way. It shows your enthusiasm for the role and keeps you fresh in their minds. We believe that a little courtesy can make a big difference!
We think you need these skills to ace Validation Engineer in Belfast
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Validation Engineer role. 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!
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 responsibilities listed, like risk assessments or process validation.
Showcase Relevant Skills:Don’t forget to showcase your skills that match the job requirements, such as knowledge of regulatory guidelines like FDA 21 CFR Part 11 and ISO13485. We love seeing candidates who understand the ins and outs of the industry!
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 any important updates from us!
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 ISO13485, as well as the specifics of IQ, OQ, and PQ processes. This will show that you're not just a candidate, but someone who truly understands the field.
✨Showcase Your Experience
Prepare to discuss your past experiences in detail, especially those that relate to risk assessments and process validation. Think of specific examples where you've successfully executed validation projects or harmonised SOPs with QMS requirements. This will help demonstrate your hands-on expertise.
✨Ask Smart Questions
Interviews are a two-way street, so come prepared with insightful questions about the company's current challenges in manufacturing validation. Inquire about their existing QMS integration efforts or how they handle legacy equipment calibration. This shows your genuine interest and helps you assess if the role is right for you.
✨Be Ready for Technical Scenarios
Expect to face technical scenarios or case studies during the interview. Practice articulating your thought process on how you would approach a risk assessment or validate a manual assembly step. This will highlight your problem-solving skills and ability to think on your feet.
