Validation Specialist

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.