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- Tasks: Lead the Validation Program ensuring compliance with key regulations and standards.
- Company: Join a dynamic company focused on quality in drug manufacturing and medical devices.
- Benefits: Enjoy career development opportunities, competitive salary, and a collaborative work environment.
- Why this job: Make a real impact in quality assurance while developing your leadership skills.
- Qualifications: Bachelor's degree in a related field and five years of relevant experience required.
- Other info: Six Sigma qualification and strong analytical skills are essential for success.
The predicted salary is between 36000 - 60000 £ per year.
Oversee all aspects of the Validation Program to ensure that validation processes and procedures are in compliance with ISO9001; ISO13485; 21 CFR 600; IVDD 98/79/EC; IVDR 2017/746 and other appropriate regulations and standards. This includes site safety requirements and applicable GxP and Good Manufacturing Practices (GMP).
Key Responsibilities:
- Management and development of robust and compliant validation processes and procedures to include maintenance, development and execution of the site Validation Master Plan and Data Integrity Governance Plan.
- Provide support and leadership to ensure compliance with both software and hardware validation regulatory requirements including 21 CFR parts 11, Annex 15 (Eudralex), GAMP and other guidance documents, as appropriate to the business needs.
- Provide validation support, resource, guidance and expertise to projects on validation requirements, including the development of required Validation Plans, preparation and execution of validation impact assessments, system risk assessments, protocols and reports.
- Provide validation resource, guidance and expertise in support of regulatory submissions, failure investigations, CAPA’s and continuous improvement initiatives.
- Development of cross functional and collaborative relationships within the facility.
- Development of effective internal and external customer relationships to ensure quality and regulatory compliance for the business with respect to validation activities.
- Preparation of validation reports, data and Key Performance Indicators for presentation to senior management as required and as an input to Management Reviews.
- Develop leadership and operational capabilities of direct reports. Establish career development plans with identified training needs and develop goals and objectives that stretch individual abilities. Provide regular and constructive performance appraisal and discipline, where appropriate.
Who you are:
- Bachelor’s Degree in a quality or science related discipline (chemistry, biology, or medical technology) or equivalent professional training.
- Five (5) years’ experience in a drug manufacturing, medical device, biologics or related industry.
- Experience in supervising and motivating personnel, managing by objectives and conducting personnel appraisals/performance reviews.
- Previous experience should demonstrate expertise in GMP, FDA regulations, SOP development, as well as an understanding of Validation and Data Integrity Principles.
- Six Sigma Qualified (Green Belt or above).
- Strong analytical and problem-solving skills, including presentation of results into meaningful reports.
- Competent in the use IT technology, such as Microsoft Word, Excel and PowerPoint.
- Good communication skills (written and verbal) with the ability to collaborate and present at all levels and functions of the organization.
Validation Manager employer: Merck Gruppe
Contact Detail:
Merck Gruppe Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Validation Manager
✨Tip Number 1
Familiarise yourself with the specific regulations and standards mentioned in the job description, such as ISO9001 and ISO13485. Understanding these frameworks will not only help you in interviews but also demonstrate your commitment to compliance and quality.
✨Tip Number 2
Network with professionals in the validation and quality assurance fields. Attend industry conferences or webinars where you can meet people who work in similar roles. This can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Prepare to discuss your experience with validation processes and how you've implemented them in previous roles. Be ready to share specific examples that highlight your problem-solving skills and ability to lead teams effectively.
✨Tip Number 4
Showcase your Six Sigma qualifications during discussions. Highlight how your Green Belt or above status has contributed to process improvements in past positions, as this aligns well with the continuous improvement initiatives mentioned in the job description.
We think you need these skills to ace Validation Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in validation processes, compliance with ISO standards, and any specific achievements in the drug manufacturing or medical device industries. Use keywords from the job description to align your skills with the role.
Craft a Compelling Cover Letter: In your cover letter, express your passion for quality assurance and validation. Discuss your experience with GMP, FDA regulations, and your leadership capabilities. Be sure to mention how you can contribute to the company's goals and compliance standards.
Showcase Your Qualifications: Clearly outline your educational background and any relevant certifications, such as Six Sigma qualifications. Highlight your analytical and problem-solving skills, and provide examples of how you've successfully managed validation projects in the past.
Proofread and Edit: Before submitting your application, thoroughly proofread your documents for any spelling or grammatical errors. Ensure that your writing is clear and professional, as this reflects your attention to detail, which is crucial for the Validation Manager role.
How to prepare for a job interview at Merck Gruppe
✨Know Your Regulations
Familiarise yourself with ISO9001, ISO13485, and other relevant regulations mentioned in the job description. Be prepared to discuss how your experience aligns with these standards and how you can ensure compliance in the role.
✨Showcase Your Leadership Skills
Highlight your experience in managing teams and developing personnel. Prepare examples of how you've motivated staff, conducted performance reviews, and established career development plans in previous roles.
✨Demonstrate Analytical Thinking
Be ready to discuss specific instances where you've used your analytical and problem-solving skills. Think of examples where you presented results in a meaningful way, especially in relation to validation processes or regulatory submissions.
✨Prepare for Technical Questions
Expect technical questions related to validation processes, GxP, and Good Manufacturing Practices. Brush up on your knowledge of software and hardware validation requirements, and be prepared to explain how you would approach various validation scenarios.
