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- Tasks: Ensure systems and processes meet quality standards in pharmaceutical manufacturing.
- Company: Join WEP Clinical, a leader in advancing clinical research and transforming lives.
- Benefits: Enjoy private healthcare, pension plans, paid leave, and volunteer days.
- Why this job: Be part of a mission-driven team that values innovation and collaboration.
- Qualifications: Bachelor's degree and 2-5 years of validation experience required.
- Other info: WEP Clinical promotes wellness, growth, and diversity in the workplace.
The predicted salary is between 36000 - 60000 £ per year.
Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring ideas that make a real difference. Be part of a mission-driven organisation dedicated to advancing clinical research and transforming lives.
The Validation Specialist is responsible for ensuring that systems, equipment, processes, and software used in the manufacture, storage, and distribution of pharmaceutical products, or the management of clinical trial services, meet regulatory and internal quality standards, including key GxP-impacting computerised software. The role involves planning, executing, and documenting validation and qualification activities in accordance with CGMP, ICH GCP, GAMP 5, EU Annexe 11, 21 CFR Part 11, and other relevant regulations.
The Ideal Candidate:
- Analytical
- Collaborative
- Adaptable
- Proactive
What You\’ll Do:
- You will oversee all Gxp-impacting systems (including equipment and software) at WEP Clinical, ensuring the validated state is maintained.
- Understand all the GxP systems at WEP Clinical and what each system is utilised for to ensure effective risk management, planning, and maintenance.
- Ensure any new GxP-impacting systems are assessed to determine the level and scope of validation for effective validation planning. Support and drive the system\’s implementation, ensuring validation deliverables are met.
- Author, review, and approve validation-related documentation, e.g., validation plans & assessments, test scripts, final reports, SOPs, and risk assessments.
- Develop and execute validation protocols (e.g., IQ, OQ, PQ) for equipment, systems, and processes.
- Key subject matter for GxP validation compliance related to driving user requirements, risk assessments, and traceability matrices within a new system initiative.
- Ensure all validation activities are performed and documented in compliance with regulatory expectations and internal SOPs.
- Collaborate cross-functionally with multiple teams & Process/System Owners to ensure validation readiness.
- Closely collaborate with IT to maintain a validated state for computer systems.
- Conduct impact assessments and change controls related to validated systems.
- Assist during regulatory inspections and audits, providing validation documentation and support.
- Maintain validation lifecycle documentation and ensure periodic reviews are completed where applicable.
- Identify opportunities for process improvement and contribute to the continuous improvement of the validation program.
- Work with the warehouses to ensure temperature mapping is completed periodically in accordance with SOP.
What You\’ll Need:
- Bachelor\’s Degree or higher (preference for pharmaceutical, life sciences, or engineering).
- Minimum 2–5 years of experience in validation within the pharmaceutical, biotech, or medical device industry.
- Expert knowledge in GAMP5 principles, EU Annex 11, 21 CFR Part 11, validation best practices for CSV and equipment.
- Strong understanding of GxP principles, regulatory requirements related to GMDP and ICH GCP.
- Experience in equipment qualification, process validation, and/or computerised system validation.
- Experience with Temperature Mapping, ERP systems, IRTs, and/or eQMS platforms is a plus.
- Excellent documentation, communication, and project management skills.
- Effective verbal and written communication skills.
- Computer literacy and proficiency in Microsoft Office, particularly Excel, are essential.
- Strong organisational skills and attention to detail.
- Pro-active & solutions-driven, effective planning, time management, organisational, and administrative skills.
- Ability to work with cross-functional teams on new process projects, incident investigation, identification of root causes, and process improvements.
- Ability to learn and understand different systems and related business needs/contexts quickly and assess overall risk.
What We Offer:
Private healthcare insurance
Long-term illness Cover
Death in service cover
Salary sacrifice pension
Annual leave
Paid maternity & paternity leave
Volunteer day
What Sets Us Apart:
WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over 15 years of experience distributing products to over 120 countries worldwide to treat unmet patient needs.
We\’re Committed to Our Team:
WEP has many initiatives to encourage wellness, growth, development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events and all we do to support our employees.
We\’re Committed to DEI:
At WEP Clinical, acceptance, recognition, and engagement are the core of our DEI values. We are committed to giving employees opportunities for personal and professional success and growth and to embracing everyone\’s unique identities.
Our services include:
Access Programs
Clinical Trial Services
Patient Site Solutions
Clinical Trial Supply
Market Access and Commercialisation
WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.
WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.
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Validation Specialist employer: WEP Clinical
Contact Detail:
WEP Clinical Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Validation Specialist
✨Tip Number 1
Familiarise yourself with GxP principles and regulations such as CGMP, ICH GCP, and GAMP 5. Understanding these standards will not only help you in the interview but also demonstrate your commitment to compliance and quality assurance.
✨Tip Number 2
Network with professionals in the pharmaceutical and biotech industries. Attend relevant conferences or webinars where you can meet people who work in validation roles. This can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples of your experience with validation processes, particularly in relation to equipment qualification and computerised system validation. Being able to articulate your hands-on experience will set you apart from other candidates.
✨Tip Number 4
Showcase your problem-solving skills by preparing to discuss how you've identified opportunities for process improvement in past roles. Highlighting your proactive approach will resonate well with the collaborative culture at WEP Clinical.
We think you need these skills to ace Validation Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure to customise your CV to highlight relevant experience in validation, particularly within the pharmaceutical or biotech industries. Emphasise your knowledge of GxP principles and any specific regulations mentioned in the job description.
Craft a Compelling Cover Letter: Write a cover letter that showcases your analytical and collaborative skills. Mention specific examples of how you've contributed to validation projects in the past and how you can bring value to WEP Clinical's mission.
Highlight Relevant Experience: In your application, clearly outline your experience with GAMP5 principles, equipment qualification, and process validation. Use bullet points to make it easy for the hiring team to see your qualifications at a glance.
Showcase Soft Skills: Don't forget to mention your organisational skills, attention to detail, and ability to work cross-functionally. These soft skills are just as important as technical expertise for the Validation Specialist role.
How to prepare for a job interview at WEP Clinical
✨Understand GxP Principles
Make sure you have a solid grasp of GxP principles and regulatory requirements. Be prepared to discuss how these principles apply to the role of a Validation Specialist and provide examples from your past experience.
✨Showcase Your Documentation Skills
Since documentation is crucial in validation, be ready to demonstrate your experience with creating and reviewing validation-related documents. Bring examples of validation plans, test scripts, or reports you've worked on to showcase your attention to detail.
✨Highlight Cross-Functional Collaboration
WEP Clinical values collaboration across teams. Prepare to discuss instances where you've successfully worked with different departments, such as IT or quality assurance, to achieve validation goals.
✨Prepare for Regulatory Questions
Expect questions related to regulatory inspections and audits. Familiarise yourself with common challenges faced during these processes and be ready to share how you've contributed to successful outcomes in previous roles.
