Senior Validation Specialist
4 weeks ago
The Senior Equipment Validation Specialist will be responsible for ensuring the accuracy and reliability of laboratory equipment and software, ensuring compliance with industry standards and regulations.
Key Responsibilities- Provide subject matter expertise for laboratory equipment calibration and validation systems.
- Participate in equipment/software validation activities, ensuring adherence to industry best practices.
- Complete validation documentation following cGMP and good documentation practices.
- Coordinate with external vendors for H&S documentation and validation documents.
- Analyze data and prepare technical reports as needed.
- Participate in equipment-related laboratory investigations to support Non-Conformances, CAPA's, Change Control, etc.
- Evaluate and update SOPs to maintain equipment and calibrations.
- Support software validation activities for laboratory systems, ensuring Data Integrity compliance and implementing remedial action plans.
- Support implementation and maintenance of laboratory informatics software/platforms and lab enterprise systems.
- Thorough knowledge of quality and regulatory requirements in Medical Device/Pharmaceutical industries.
- Previous experience with LIMS is preferable.
- Possess strong technical and problem-solving skills.
- Expertise in laboratory equipment/software validation, calibration, and maintenance, including 21 CFR Part 11.
- Previous experience with the use of electronic data management systems.
- Proficiency in technical documentation.
- Effective communicator who can influence decisions and work independently or within teams.
- Ability to collaborate with a wide scope of contacts at different levels of seniority.
- Highly organized with excellent time management and attention to detail.
- Flexible and responsive to changing priorities and ad-hoc requests.
- Continuously updates technical knowledge and implements new processes.
- Degree in a relevant science or engineering field, plus 5 years' experience in laboratory equipment validation/calibration in Medical Device/Pharmaceutical Industry.
- Experience with software validations, 21 CFR Part 11, and calibration management systems.
- Proficiency in Microsoft Office and database applications.
- Hybrid working role based mainly at the GDC site, combining laboratory and office environments.
- Exposure to chemicals, reagents, and biological agents within laboratory areas.
- Option for up to 2 days of remote work per week after role establishment, with minimal travel (5-10 days annually).
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