Lead Validation Engineer in Holywell Row - CV-Library

Job Title: Validation Engineer (Medical Device Manufacturing)

Location: Suffolk, UK

Company Overview: Join our dynamic client, a leading medical device manufacturing company. They are specialists in developing cutting-edge medical devices that meet the highest quality and regulatory standards.

Position Overview: We are seeking a talented Validation Engineer to join our client in Suffolk. The Validation Engineer will play a critical role in ensuring the reliability, safety, and efficacy of our medical devices through comprehensive validation processes. This role will primarily focus on validation activities, encompassing approximately 80% of the workload, with the remaining 20% dedicated to quality-related tasks.

Key Responsibilities:

Plan, execute, and document validation activities for new product development, process improvements, and equipment qualifications.
Develop validation protocols, reports, and procedures in compliance with regulatory requirements and internal quality standards.
Perform risk assessments and impact analyses to identify validation requirements and ensure the robustness of validation strategies.
Collaborate cross-functionally with R&D, manufacturing, quality assurance, and regulatory affairs teams to ensure alignment and timely completion of validation activities.
Provide technical expertise and support during regulatory inspections and audits related to validation processes.
Participate in continuous improvement initiatives to enhance validation methodologies, processes, and systems.
Contribute to quality management activities, including non-conformance investigations, CAPA implementation, and internal audits. Qualifications:

Bachelor's degree in engineering, science, or related field. Master's degree preferred.
Previous experience in validation within the medical device industry is essential.
Strong understanding of validation principles, methodologies, and regulatory requirements.
Proficiency in writing validation protocols, reports, and procedures.
Excellent analytical and problem-solving skills with meticulous attention to detail.
Effective communication and interpersonal skills, with the ability to collaborate across functional teams.
Self-motivated and able to work both independently and as part of a team in a fast-paced environment.
Knowledge of quality management systems (e.g., ISO 13485) and statistical analysis techniques is advantageous. Why Join Us:

Opportunity to make a meaningful impact on patients' lives by contributing to the development of innovative medical devices.
Competitive salary and comprehensive benefits package.
Collaborative and supportive work environment with opportunities for professional growth and development.
Located in the picturesque county of Suffolk, offering a high quality of life with access to beautiful countryside and coastal areas. If you are passionate about validation engineering and eager to contribute to the advancement of healthcare technology, we invite you to apply for this exciting opportunity. Join our client to deliver life-changing medical solutions. Apply now by submitting your CV or contact Lewis Woollard direct on (phone number removed)