About the role:
The Senior Equipment Validation Specialist will be responsible for completion of all validation and compliance activities relating to purchase of new and updating of existing equipment/software located within Laboratories at Convatec Global Development Centre (GDC).
Key Responsibilities:
* Provide Subject Matter Expertise for laboratory equipment calibration and validation systems to ensure compliance with ISO13485, FDA 21CFR Part 820, and cGMP.
* Participate in Equipment/Software Validation activities FAT, SAT, IQ/OQ/PQ 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 Maximo, LIMS, ELN.
About You:
* Thorough knowledge of quality and regulatory requirements ISO13485, cGMP 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 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 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.
Qualifications/Education:
* Degree in 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.
Working Conditions:
* Hybrid working role based mainly at 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.
About us:
We aim to improve lives of millions through pioneering trusted medical solutions.
This role challenges you to make a real difference.
This is stepping up to a challenge that will move you.