Validation Engineer
An exciting opportunity has arisen to manage the validation of computerized systems in the medical device industry.
Key Responsibilities
* Validation Lifecycle Management:
o Provide technical validation support throughout the full validation lifecycle, ensuring alignment with site objectives.
o Develop, review, and approve validation plans, protocols, discrepancy reports, and summary reports.
* Protocol Development and Execution:
o 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:
o Maintain detailed knowledge of pharmaceutical and automation processes, ensuring compliance with all applicable regulations and standards.
o Assist in refining and improving validation lifecycle processes across multisite and local operations.
* Data Analysis and Reporting:
o Collate, analyze, and report validation data and metrics to stakeholders.
* Support Quality Management Systems:
o Provide validation expertise for change controls, deviations, and CAPA processes.
o Update and maintain validation Standard Operating Procedures (SOPs) per site and corporate requirements.
* Project Coordination:
o Manage and prioritize validation-related projects to align with site priorities.
o 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.