At a Glance
- Tasks: Ensure validation activities meet safety and quality standards in a dynamic consultancy environment.
- Company: Join a leading consultancy serving the pharmaceutical, medical device, and food supplement industries.
- Benefits: Enjoy competitive pay, professional development opportunities, and a collaborative work culture.
- Why this job: Make a real impact on product safety while working with innovative teams and cutting-edge technology.
- Qualifications: 5+ years in validation roles; degree in engineering or equivalent experience required.
- Other info: Opportunity to lead projects and shape validation strategies across various sectors.
The predicted salary is between 43200 - 72000 £ per year.
Our client is a specialist consultancy providing expert services to the pharmaceutical, medical device, and food supplement industries across the full product lifecycle. As the Validation Engineer, you will play a critical role in ensuring all validation and qualification activities meet regulatory, safety, and quality standards. You will work closely with cross-functional teams, provide technical leadership, and help shape validation strategies across equipment, facilities, utilities, and control systems.
Responsibilities:
- Execute validation/qualification activities in line with cGMP, EU Annex 11 & 15, and company QMS.
- Author and report validation documentation (URS, IQ/OQ/PQ, Validation Summary Reports).
- Serve as subject matter expert for Computerised System Validation aligned with GAMP 5 and 21 CFR Part 11.
- Manage validation projects and coordinate between key stakeholders.
- Review maintenance histories, lead investigations, support audits, and improve processes.
- Provide technical input to equipment design and commissioning plans.
- Ensure compliance with engineering, safety, and quality standards.
Requirements:
- 5+ years of experience in a similar validation role within a pharmaceutical or GMP-regulated environment.
- Degree in Mechanical, Electrical, Chemical Engineering, or equivalent experience.
- Deep understanding of GMP, validation requirements, and regulatory expectations.
- Skilled in Change Control and development of Master Validation Plans.
Contact Detail:
Advanced Resource Managers Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Validation Engineer
✨Tip Number 1
Network with professionals in the pharmaceutical and medical device industries. Attend relevant conferences or webinars to meet potential colleagues and learn about the latest trends in validation engineering.
✨Tip Number 2
Familiarise yourself with the specific regulations and standards mentioned in the job description, such as cGMP, EU Annex 11 & 15, and GAMP 5. This knowledge will not only help you in interviews but also demonstrate your commitment to the role.
✨Tip Number 3
Prepare to discuss your previous validation projects in detail. Be ready to explain your role, the challenges you faced, and how you ensured compliance with quality and safety standards.
✨Tip Number 4
Showcase your technical leadership skills by discussing how you've successfully coordinated with cross-functional teams in past roles. Highlight any experience you have in managing validation projects and stakeholder communication.
We think you need these skills to ace Validation Engineer
Some tips for your application 🫡
Understand the Role: Read the job description thoroughly to grasp the key responsibilities and requirements of the Validation Engineer position. Tailor your application to highlight relevant experience and skills that align with these expectations.
Highlight Relevant Experience: In your CV and cover letter, emphasise your 5+ years of experience in validation roles, particularly within pharmaceutical or GMP-regulated environments. Use specific examples to demonstrate your expertise in cGMP, EU Annex 11 & 15, and Computerised System Validation.
Showcase Technical Skills: Detail your technical skills related to validation documentation, project management, and compliance with engineering standards. Mention your familiarity with GAMP 5 and 21 CFR Part 11, as well as your ability to manage validation projects and coordinate with stakeholders.
Craft a Strong Cover Letter: Write a compelling cover letter that not only summarises your qualifications but also conveys your passion for the role. Explain why you are interested in working with the consultancy and how you can contribute to their success in the pharmaceutical, medical device, and food supplement industries.
How to prepare for a job interview at Advanced Resource Managers
✨Know Your Regulations
Familiarise yourself with cGMP, EU Annex 11 & 15, and the specific validation requirements relevant to the pharmaceutical industry. Being able to discuss these regulations confidently will demonstrate your expertise and understanding of the role.
✨Prepare Your Documentation Examples
Be ready to discuss your experience with authoring validation documentation such as URS, IQ/OQ/PQ, and Validation Summary Reports. Having specific examples at hand will showcase your practical knowledge and attention to detail.
✨Highlight Your Project Management Skills
Since the role involves managing validation projects, prepare to talk about your experience coordinating with cross-functional teams and stakeholders. Share examples of how you successfully led projects and overcame challenges.
✨Showcase Your Technical Leadership
As a Validation Engineer, you'll need to provide technical input on equipment design and commissioning plans. Be prepared to discuss how you've contributed to similar processes in the past and how you can add value to the team.