Senior Equipment Validation Specialist

Convatec — Manchester, England, United Kingdom

Convatec is a global medical products and technologies company focused on solutions for managing chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care and Infusion Care. The company employs more than 10,000 colleagues across around 90 countries and reported revenues exceeding $2 billion in 2024. Convatec is a constituent of the FTSE 100 Index (LSE:

CTEC).

The Senior Equipment Specialist will be responsible for the completion of all validation and compliance activities related to the purchase of new and the updating of existing equipment and software located within the Laboratories at Convatec Global Development Centre (GDC). The role requires strong attention to detail, the ability to manage multiple projects, excellent problem‑solving skills and effective communication.

• Provide subject‑matter expertise for laboratory equipment calibration and validation systems to ensure compliance with ISO 13485, FDA 21 CFR 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 in accordance with cGMP and good documentation practices.
• Coordinate with external vendors for H&S documentation and validation documents.
• Analyse data and prepare technical reports as needed.
• Participate in equipment‑related laboratory investigations to support non‑conformances, CAPAs, change control, etc.
• Evaluate and update SOPs to maintain equipment and calibrations.
• Review and approve in‑house and external calibrations of laboratory equipment.
• 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).

• Thorough knowledge of quality and regulatory requirements (ISO 13485, cGMP) in the Medical Device/Pharmaceutical industries.
• Previous experience with LIMS is preferable.
• Strong technical and problem‑solving skills.
• Expertise in laboratory equipment/software validation, calibration and maintenance, including 21 CFR Part 11.
• Previous experience with 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 range of contacts at different seniority levels.
• Highly organized with excellent time‑management and attention to detail.
• Flexible and responsive to changing priorities and ad‑hoc requests.
• Committed to continuous technical knowledge updates and process improvements.

• Degree in a relevant science or engineering field, plus five years’ experience in laboratory equipment validation/calibration within the Medical Device/Pharmaceutical Industry.
• Experience with software validations, 21 CFR Part 11 and calibration management systems.
• Proficiency in Microsoft Office and database applications.

• Hybrid role based in Deeside in 2026, moving to Manchester in 2027.
• Combination of laboratory and office environments.
• Exposure to chemicals, reagents and biological agents within laboratory areas.
• Option for up to two days of remote work per week after role establishment, with minimal travel (5‑10 days annually).

Convatec provides equal employment opportunities for all current employees and applicants. No discrimination will occur because of race, religion, creed, colour, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, sexual orientation, gender identity, military or veteran status, genetic predisposition, or any other basis prohibited by law.