Senior Equipment Validation Specialist

Rhian_Convatec; Manchester; Hybrid; GBP 50,000 - 70,000; Full time

Job summary

A leading medical solutions company in Manchester is seeking a Senior Equipment Specialist. This role involves ensuring compliance with regulatory standards for laboratory equipment, participating in validation activities, and analyzing data to support medical technology development. The ideal candidate has a degree in a relevant field and a minimum of 5 years' experience in the Medical Device or Pharmaceutical industries. Flexible working options are available.

Benefits

Hybrid working options

Exposure to cutting-edge technology

Collaborative working environment

Qualifications

• 5 years' experience in laboratory equipment validation/calibration.
• Experience with software validations and calibration management systems.
• Proficiency in technical documentation.

Responsibilities

• Ensure compliance with ISO13485, FDA 21CFR Part 820, and cGMP.
• Participate in validation activities ensuring industry best practices.
• Analyze data and prepare technical reports.

Skills

Quality and regulatory requirements knowledge

Technical and problem‑solving skills

Laboratory equipment/software validation

Effective communication

Organizational skills

Education

Degree in relevant science or engineering field

Tools

Microsoft Office

LIMS

Job description

About Convatec

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 more than 10,000 colleagues, we provide our products and services in around 90 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 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit http://www.convatecgroup.com

Convatec has announced a major milestone in our R&D journey and commitment to our vision of pioneering trusted medical solutions to improve the lives we touch. We have unveiled plans to relocate the majority of our UK-based research and development (R&D) activities from Deeside to Manchester from 2027, alongside a significant expansion of our facilities in Boston.

An exciting future in Manchester

The new, planned Manchester facility has the potential to be a major R&D hub in our global network which will initially function as the company’s global testing laboratories, with cutting‑edge analytical R&D capabilities including quality control and materials, regulatory functions, and health innovation, positioning Convatec at the forefront of medical technology development. Our new state‑of‑the‑art facilities will also strengthen our collaboration with Manchester’s vibrant life sciences ecosystem, which includes leading universities, hospitals, and research institutions.

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.
• 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).

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 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 2 days of remote work per week after role establishment, with minimal travel (5‑10 days annually).

Beware of scams online or from individuals claiming to represent Convatec

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 [e-mail].

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.

Already a Convatec employee?

If you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and View "Convatec Internal Career Site - Find Jobs". Thank you.