Validation Engineer (Contract)
Location: Los Angeles, CA
Role Overview
Looking for an experienced Validation Engineer to join our team on a temporary, onsite basis. In this role, you will report to the Manager of Quality Engineering and play a key role in supporting our quality engineering team with documentation and validation tasks related to automation projects. Your responsibilities will include drafting design specifications, conducting validation testing, and collaborating with internal departments and external vendors to ensure successful project completion.
Key Responsibilities
- Prepare and review documentation such as user requirements, design specifications, and testing protocols.
- Conduct hands-on validation activities for automation projects and resolve any discrepancies in protocols.
- Collaborate with internal departments and external vendors to establish schedules and coordinate validation activities.
- Participate in project meetings and provide status updates to relevant stakeholders.
- Manage project tasks and escalate issues to leadership as necessary.
Qualifications
- Bachelor’s Degree with at least 5 years of experience in Quality and/or Manufacturing in the pharmaceutical, biotechnology, biologics, or cell therapy industries.
- Strong understanding of equipment and computerized systems, with knowledge of data integrity and change control management.
- Excellent interpersonal and technical writing skills.
- Preferred experience with automation equipment, bioreactors, temperature-controlled units, and cell processing systems.
- Proficient in Microsoft Office tools, including PowerPoint, MS Project, Excel, and Word.
- Ability to work collaboratively across departments and with external vendors.
