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Due to ongoing growth, our client is actively seeking an experienced Validation Specialist to join their manufacturing team. This role is ideal for candidates with a strong background in the validation of manufacturing equipment and a passion for continuous improvement.
Position Overview:The Validation Specialist will play a key role in the qualification and calibration of manufacturing equipment. In addition to supporting continuous improvement initiatives, this role is critical in ensuring compliance with regulatory standards and internal quality systems.
Education & Experience Requirements:
- Bachelor’s degree in chemistry, Engineering, or a related discipline.
- Minimum of 3 years’ experience in a validation role within a manufacturing environment.
- Prior experience in medical device, pharmaceutical, or chemical manufacturing environments.
- Good understanding of manufacturing technology and quality assurance processes.
- Knowledge of Quality Management Systems for medical devices (EN ISO 13485, 21 CFR 820).
- Proven experience in validation/qualification and project management.
- Experience conducting audits of manufacturers and suppliers.
Key Responsibilities:
- Develop and compile validation protocols and reports.
- Perform qualification and validation of manufacturing equipment and processes.
- Collaborate cross-functionally to ensure timely execution of validation activities.
- Provide support to the Quality Manager on various quality initiatives.
- Train production staff in in-process controls and Batch Manufacturing Records (BMRs).
- Promote compliance with the Quality Management System (QMS), including SOPs and good documentation practices.
- Support investigations using structured problem-solving techniques.
- Assist in deploying and implementing updated documentation and procedures.
- Participate in on-site customer and external audits (e.g., by notified bodies).
- Conduct internal and supplier audits in line with the audit schedule.
- Gather and analyse data to develop quality performance metrics.
- Provide QA support across departments to ensure regulatory and customer compliance.
- Support change control processes, including training and communication of changes.
Skills:
- Excellent written and verbal communication skills.
- Strong team player with the ability to work independently.
- Strong organisational skills with attention to detail.
This position offers a competitive salary and excellent benefits.
The Candidates must be living in the UK and be eligible to work.
