Location
Cambridge, Cambridgeshire | United Kingdom
Job description
Sapphiros UK, a pioneering force in medical technology, is on the brink of a new era as we launch groundbreaking products into the market. As we embark on this exciting journey, we are seeking an experienced Validation Engineer to join our small but growing team. You'll spearhead the planning, execution, and documentation of validation activities throughout product lifecycles. Your expertise will ensure compliance with regulatory mandates and industry benchmarks.
This is a unique opportunity to be at the forefront of cutting-edge developments in consumer and near-patient diagnostics. 2024 is an exciting year as we further build and scale our business. This growth will create consistent opportunities for personal and professional development. Simply put, those who join us now will play a significant role in shaping the future of the company, and their role within.
Roles and Responsibilities:
- Validation Planning: Develop comprehensive plans to validate medical devices, aligning with regulatory requisites and company protocols.
- Protocol Development: Craft validation protocols including IQ, OQ, PQ, and VMP in accordance with product specifications and regulatory standards.
- Execution of Validation Activities: Conduct thorough validation testing and inspections to verify equipment, processes, and systems meet predetermined criteria.
- Risk Management: Identify potential risks in the validation process and strategize mitigation tactics for optimal product quality.
- Data Analysis and Interpretation: Analyze validation data, ensuring accuracy and compliance, and recommend corrective actions or process enhancements.
- Documentation and Reporting: Maintain meticulous documentation of validation activities and prepare detailed reports for regulatory review.
- Cross-functional Collaboration: Collaborate with R&D, Quality Assurance, Regulatory Affairs, and Manufacturing to ensure alignment of validation activities with project goals.
- Regulatory Compliance: Stay abreast of relevant regulations and standards, ensuring adherence to validation requirements.
- Continuous Improvement: Identify opportunities for process optimization and implement best practices to enhance validation efficiency.
- Training and Mentoring: Provide guidance to team members on validation principles and mentor junior engineers.
- Audits and Inspections: Support internal and external audits, ensuring audit readiness and facilitating responses.
- Change Control: Evaluate proposed changes and implement procedures to update validation documentation.
Preferred Experience and Skills:
- Proficiency in validation protocols and methodologies including IQ/OQ/PQ, FMEA, and Control Plans.
- Some CSV experience would be advantageous
- Familiarity with metrology, calibration, inspection, and testing techniques.
- Experience in packaging and serialization processes.
- Knowledge of GAMP 5 and solid communication skills for effective collaboration.
We value our team and offer a comprehensive benefits package, including:
- Healthcare coverage, encompassing optical, dental, and worldwide travel.
- Generous annual leave of 25 days, with an additional 3 days off for Christmas celebrations.
- Life insurance for financial security and peace of mind.
- Employee Assistance Programs to support your well-being.
- Pension plan for a secure future.
- Income protection to safeguard against unforeseen circumstances.
- Enhanced sick leave provisions, ensuring your health and recovery are prioritised.
- Outstanding parental leave policies, supporting you during important life moments.
About Us: Sapphiros UK is the fusion of two innovative entities - Biocrucible in Cambridge and Flexotronix in Hove. Biocrucible specialises in molecular detection technologies for near-patient and at-home testing, while Flexotronix is a center of excellence in high-speed printed electronics manufacturing. Together, they form Sapphiros UK, a company committed to pushing the boundaries of what's possible.
Apply now:
We do not discriminate, we are interested in you, your skills, experience and nothing more. If you require accommodations or adjustments to complete the application or interview process, please contact [email protected]
We look forward to speaking with you.
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