Job Information
ConvaTec Senior Equipment Validation Specialist in Deeside, United Kingdom
Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, 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. Convatec’s revenues in 2023 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit http://www.convatecgroup.com
About the role:
The Senior Equipment Specialist will be responsible for the completion of all validation and compliance activities relating to the purchase of new and updating of existing equipment/software located within the Laboratories at Convatec Global Development Centre (GDC). The Senior Equipment Specialist should be detail-oriented, able to work on multiple projects and adapt to changes, with good problem-solving skills and strong communication are essential.
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 (e.g., 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 (e.g., 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 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).
This revised version aims to maintain clarity and focus while preserving all essential information about the role.
About us:
Our ambitions will bring the very best out in you. You’ll be pushed to aim higher and really own your work. You’ll be encouraged and supported to make things happen, too. It can be challenging. But, as the progress you make will help improve the lives of millions, it’ll be worth it.
This is stepping up to a challenge.
This is work that’ll move you.
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A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.
If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at careers@Convatec.com .
Equal opportunities
Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.
Notice to Agency and Search Firm Representatives
Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
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