Senior Validation Specialist

3 weeks ago

Deeside, Flintshire, United Kingdom ConvaTec Full time

About the Role:

The Senior Equipment Validation Specialist will be responsible for ensuring the compliance of laboratory equipment and software with regulatory requirements such as ISO13485, FDA 21CFR Part 820, and cGMP. This involves providing subject matter expertise for laboratory equipment calibration and validation systems, participating in equipment/software validation activities, and completing validation documentation following cGMP and good documentation practices.

Key Responsibilities:

  • Provide subject matter expertise for laboratory equipment calibration and validation systems to ensure compliance with regulatory requirements.
  • Participate in equipment/software validation activities, including FAT, SAT, IQ/OQ/PQ, to ensure 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, including Maximo, LIMS, ELN.

About You:

  • 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.

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 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).

About us:

Our company, ConvaTec, is a global medical products and technologies company, focused on solutions for the management of chronic conditions. We provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs.

We are a company that values our employees and provides opportunities for growth and development. We are committed to making a positive impact on the lives of our customers and the communities we serve.

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