Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Execute validation activities and ensure compliance with quality standards in a dynamic environment.
- Company: Join GMP Healthcare Ltd, a leading consultancy in the pharmaceutical and medical device industries.
- Benefits: Enjoy a collaborative culture, professional growth opportunities, and a chance to make an impact.
- Why this job: Be part of a diverse team with over 400 years of industry expertise and contribute to life-saving innovations.
- Qualifications: Bachelor’s degree in engineering or related field; strong understanding of manufacturing processes required.
- Other info: Ideal for those passionate about quality assurance and eager to learn in a fast-paced setting.
The predicted salary is between 36000 - 60000 £ per year.
GMP Healthcare Ltd is a consultancy service provider for the pharmaceutical, medical device, and food supplements industry. Our team of over 100 professionals offers support across all GxPs and provides expertise throughout the product life-cycle and manufacturing process.
Role and Responsibilities
- Executing validation and qualification activities, authoring and reporting validation activities within the framework of cGMP – Annex 11 & 15 and in compliance with QMS requirements.
- Managing compliance to Business and Engineering Quality standards.
- Ensuring Engineering design meets safety standards for emissions.
- Validating support to project management team.
- Reviewing equipment maintenance history, investigation and audit support, process/component improvement project support, and reliability engineering support.
- Having a good working knowledge of Validation requirements for Equipment / Facilities / Utilities including associated control systems, and understanding EU GMP Annex 11, 21 CFR Part 11, GAMP 5 and associated computerized system validation within the pharmaceutical environment.
- Writing User Requirement Specifications, Design / Installation / Operational / Performance Qualification protocols and reports for validation and/or trial purposes.
- Translating local, corporate and regulatory requirements into validation requirements.
- Managing and coordinating Validation Engineering project activities between key stakeholders.
- Having a detailed understanding of GMP, quality assurance and documentation systems in a pharmaceutical environment.
- Possessing a broad knowledge of validation practices, standards and regulatory requirements/expectations i.e. Annex 11 & 15 and industrial guidelines such as GAMP.
- Providing validation engineering technical support related to the operation, maintenance, installation, start-up/commissioning, testing, and qualification of Lifesciences process equipment and related systems within a manufacturing facility.
- Developing Master Validation Plans and writing Validation Summary Reports.
- Understanding Change Control and Change Reporting as it pertains to validation.
- Providing input to process equipment design, development of start-up documents, commissioning plans, and execution of commissioning plans.
Knowledge, Training & Experience
- Bachelor’s degree in mechanical, electrical, or chemical engineering or related field, or equivalent experience.
- Comprehensive understanding of complex manufacturing processes.
- Working knowledge of Good Manufacturing Practice type systems and practices in a manufacturing environment.
- Ability to communicate and express ideas clearly across all levels of the organization.
- Skilled in Microsoft Office applications including Project, Word, and Excel.
Validation Engineer employer: GMP Healthcare Ltd
Contact Detail:
GMP Healthcare Ltd Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Validation Engineer
✨Tip Number 1
Familiarise yourself with the specific regulations and standards mentioned in the job description, such as EU GMP Annex 11 and 21 CFR Part 11. This knowledge will not only help you understand the role better but also demonstrate your commitment to compliance during any discussions.
✨Tip Number 2
Network with professionals in the pharmaceutical and validation engineering fields. Attend industry conferences or webinars where you can meet people who work at GMP Healthcare Ltd or similar companies. Building these connections can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss your experience with validation processes and tools in detail. Be ready to share specific examples of how you've contributed to compliance and quality assurance in previous roles, as this will showcase your practical knowledge and problem-solving skills.
✨Tip Number 4
Research GMP Healthcare Ltd's recent projects and initiatives. Understanding their current focus areas and challenges can help you tailor your conversations and show that you're genuinely interested in contributing to their success.
We think you need these skills to ace Validation Engineer
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly understand the responsibilities of a Validation Engineer as outlined in the job description. This will help you tailor your application to highlight relevant skills and experiences.
Tailor Your CV: Customise your CV to reflect your experience with validation processes, compliance with GMP standards, and any relevant engineering qualifications. Use specific examples that demonstrate your expertise in areas like User Requirement Specifications and validation protocols.
Craft a Compelling Cover Letter: Write a cover letter that connects your background to the specific requirements of the role. Mention your understanding of cGMP, GAMP guidelines, and how your previous experiences align with the responsibilities listed in the job description.
Highlight Relevant Skills: In your application, emphasise your skills in project management, communication, and technical support related to validation engineering. Make sure to mention your proficiency in Microsoft Office applications, as this is a key requirement for the role.
How to prepare for a job interview at GMP Healthcare Ltd
✨Know Your GMP Standards
Familiarise yourself with Good Manufacturing Practices (GMP) and the specific regulations like EU GMP Annex 11 and 15. Be prepared to discuss how these standards apply to validation processes and how you have implemented them in past roles.
✨Showcase Your Technical Skills
Highlight your experience with validation protocols, including User Requirement Specifications and various qualification reports. Be ready to provide examples of how you've successfully executed validation activities in compliance with QMS requirements.
✨Communicate Clearly
Effective communication is key in this role. Practice articulating complex technical concepts in a straightforward manner, as you'll need to convey ideas clearly across different levels of the organisation.
✨Prepare for Scenario Questions
Expect scenario-based questions that assess your problem-solving skills in real-world situations. Think of examples where you've managed compliance issues or improved processes, and be ready to discuss the outcomes.
