Qualification & Validation Engineer
Pharmaceutical Manufacturing
Hybrid or On-site | Flexible working arrangements considered
Role Summary:
A dynamic and regulated manufacturing site in the pharmaceutical sector is seeking a Validation Engineer to support the qualification of equipment, execution of process validation activities, and ensure the ongoing compliance of manufacturing operations.
This role offers a rewarding opportunity to contribute to critical validation and requalification initiatives, collaborate with cross-functional teams, and play an integral part in maintaining high standards of product quality, safety, and regulatory adherence.
As a key member of the validation function, you will lead and execute validation protocols, support technical transfer, and provide technical expertise aligned with global compliance standards. This is a hybrid or on-site position, with some flexibility depending on project needs.
Key Responsibilities:
Validation Strategy & Execution
Lead the planning, execution, and reporting of Process Validation (PV) and Process Performance Qualification (PPQ) activities
Deliver equipment, system, and utility qualification in line with cGMP, FDA, and EU expectations
Support the development and lifecycle maintenance of validation protocols, ensuring regulatory alignment
Provide technical interpretation of global validation standards including those for aseptic processing, sterilisation, lyophilisation, and depyrogenation
Maintain the validated status of equipment and systems, supporting ongoing manufacturing operations
Compliance & Documentation
Ensure all validation activities are fully documented and audit-ready
Contribute to regulatory inspection readiness and participate in audits as needed
Support change control processes and provide validation input on cross-functional projects
Ensure all documentation aligns with quality and compliance frameworks including GAMP, ISPE, and ISO guidelines
Continuous Improvement & Technical Collaboration
Identify opportunities to enhance validation processes and methodologies
Collaborate with technical, quality, and engineering teams to support product transfers and process improvements
Troubleshoot validation-related challenges and support resolution of quality issues
Qualifications & Experience:
Education & Background
Degree in a scientific or engineering discipline (e.g., Chemistry, Microbiology, Pharmacy, Chemical or Mechanical Engineering)
Industry Experience
3–5 years of experience in pharmaceutical or healthcare manufacturing, with a strong focus on validation or process engineering
Skills & Knowledge:
In-depth understanding of process validation requirements and lifecycle approach
Familiarity with GAMP, ISPE Baseline Guides, and global regulatory frameworks
Knowledge of quality management systems and validation-related regulatory guidance (AAMI/ANSI, PDA, ISO)
Strong technical writing and documentation skills
Effective communicator with the ability to engage across technical and operational teams
Soft Skills:
Highly motivated, collaborative, and resilient under pressure
Strong ownership and accountability in managing tasks and timelines
Pragmatic problem-solver with a continuous improvement mindset
What’s in it for you?
Opportunity to work on high-impact validation projects across a regulated, fast-paced environment
Flexible work arrangements, with hybrid options available depending on role scope
Career development and exposure to technical transfer and global compliance practices
Collaborative, quality-driven culture with strong support for professional growth
This is an excellent opportunity for a validation professional looking to broaden their experience in a technically challenging and regulated pharmaceutical environment. If you're ready to take the next step in your career, we’d love to hear from you!