About the Job
An exciting opportunity has arisen for a Validation Engineer to join my client's dynamic validation team. This role focuses on managing the validation of computerized systems, specifically in the medical device industry. Key responsibilities include developing and reviewing validation documentation in alignment with industry standards and regulatory guidelines.
Key Responsibilities
- Validation Lifecycle Management:
- Provide technical validation support throughout the full validation lifecycle, ensuring alignment with site objectives.
- Develop, review, and approve validation plans, protocols, discrepancy reports, and summary reports.
- Protocol Development and Execution:
- Utilize engineering, vendor, and customer specifications to create and execute equipment testing protocols while adhering to company and customer procedures and good documentation practices.
- Compliance and Improvement:
- Maintain detailed knowledge of pharmaceutical and automation processes, ensuring compliance with all applicable regulations and standards.
- Assist in refining and improving validation lifecycle processes across multisite and local operations.
- Data Analysis and Reporting:
- Collate, analyze, and report validation data and metrics to stakeholders.
- Support Quality Management Systems:
- Provide validation expertise for change controls, deviations, and CAPA processes.
- Update and maintain validation Standard Operating Procedures (SOPs) per site and corporate requirements.
- Project Coordination:
- Manage and prioritize validation-related projects to align with site priorities.
- Participate in multidisciplinary teams, including investigation and change control initiatives.
Qualifications
- Bachelor's degree in Science, Engineering, or a related field.
- Strong understanding of cGMPs and global regulatory requirements.
- Demonstrated problem-solving skills with excellent oral and written communication abilities.
- Minimum of 3 years' experience in a similar role.
Preferred Experience
- Expertise in equipment qualification and the validation lifecycle.
- Familiarity with Quality and Document Management Systems such as TrackWise (Deviations, CAPA, Change Control), Maximo, CDOCs, and Kneat.
- Ability to work independently, proactively, and in collaboration with cross-functional teams.
- Strong organizational skills and adaptability in managing multiple tasks within project environments.
- Team-oriented mindset with a focus on collaboration and effective decision-making.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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