Qureos Mentor

Katalyst Healthcares & Life Sciences

<div><div><b>Job Description:</b><br>
We are seeking a highly skilled and experienced Validation Specialist/Engineer to support commissioning and qualification activities for our client's facility in PA. The ideal candidate will have a strong background in executing validation life cycle deliverables in compliance with ISPE C&amp;Q guidelines, with hands-on expertise in analytical instrumentation and controlled temperature unit qualifications.<br>
<b>Responsibilities:</b>
<ul><li>Develop, review, and execute validation life cycle deliverables (protocols, reports, and associated documentation).
</li><li>Perform commissioning and qualification activities in alignment with ISPE C&amp;Q guidelines.
</li><li>Support the qualification of analytical instrumentation and controlled temperature units (CTUs).
</li><li>Utilize Kneat e-validation software for document development, execution, and approval (preferred).
</li><li>Ensure compliance with internal quality standards, regulatory requirements, and industry best practices.
</li><li>Provide technical expertise, troubleshooting, and guidance during qualification activities.
</li><li>Collaborate effectively with cross-functional teams, including Quality, Engineering, and Operations.
</li><li>Maintain accurate documentation and contribute to continuous improvement of validation processes.
</li></ul><b>Qualifications:</b>
<ul><li>Minimum 4+ years of experience in commissioning, qualification, and validation within a regulated environment.
</li><li>Strong working knowledge of ISPE C&amp;Q guidelines.
</li><li>Prior experience with analytical instrumentation qualification and controlled temperature unit qualification.
</li><li>Experience with Kneat e-validation software is highly desirable.
</li><li>Excellent technical writing skills with attention to detail and accuracy.
</li><li>Strong verbal and written communication skills.
</li><li>Effective interpersonal skills with the ability to work collaboratively across teams.
</li><li>Bachelor's degree in Engineering, Life Sciences, or related technical discipline.
</li><li>Experience in pharmaceutical or biotech industry.
</li><li>Familiarity with current GMP regulations and validation best practices.</li></ul></div></div>

Validation Specialist, Senior

Validation Engineer, Senior

Join Katalyst Healthcares & Life Sciences and explore 3   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Katalyst Healthcares & Life Sciences

About Company

Validation Specialist, Senior

Validation Engineer, Senior

Validation Specialist, Senior