- Support ImmPACT Bio's Quality Engineering group with documentation and validation needs.
- Draft URS documents, design specifications, testing protocols, and final reports.
- Perform hands on validation execution for automation implementation project.
- Draft protocol discrepancy reports and support resolution.
- Review and approval of validation documents.
- Utilize specified ImmPACT Bio document review / approval process to submit specifications, forms, and protocols for approval.
- Establish schedules with vendors and internal departments as needed.
- Liaise between support organizations, Microbiology, Quality, Engineering, Validation, Regulatory Affairs, Process Development, etc.
- Attend Project meetings and relay project status as required.
- Write / review equipment and computer system documentation - specifications, C&Q test protocols, final reports, and route for approval as required.
- Scheduling equipment and computer systems validation execution and documentation activities in accordance with project priorities.
- Escalate issues to leadership as needed.
- May perform project management and other tasks, as needed.
- Bachelor's Degree and 5+ years' experience in Quality and/or Manufacturing within pharmaceutical, biotechnology, biologics, and/or cell therapy operations
- Knowledgeable in various areas of equipment and computerized systems with strong understanding of data integrity, life cycle approach, and change control management.
- Self-motivated / disciplined.
- Experience with automation equipment, bioreactors, temperature-controlled units, and cell processing systems preferred.
- Strong interpersonal communications skills with excellent technical writing abilities.
- Demonstrated application of engineering principles on projects.
- Possess in-depth knowledge of cGMP and regulations related to biotech / pharmaceutical qualifications.
- Proficient in Microsoft Office tools (Power point, MS Project, Excel, and Word).
- Able to work collaboratively and cross-functionally with other departments and vendors
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Senior Validation Engineer - Los Angeles, United States - ImmPACT Bio
Description
ImmPACT Bio USA, Inc., is a clinical-stage company dedicated to the discovery of transformative chimeric antigen receptor (CAR) T-cell therapies that address key biological challenges in treating cancer and autoimmune diseases. The company's logic-gate-based CAR T-cell platforms, licensed from University of California, Los Angeles (UCLA) Technology Development Group, are specifically designed to deplete B cells, prevent antigen escape, and overcome the immunosuppressive tumor microenvironment. The company's technology is based on the work of pioneering scientists Yvonne Chen, Ph.D., and Antoni Ribas, M.D., Ph.D., both from UCLA.
ImmPACT Bio is looking for an exceptional individual to join as a temporary Senior Validation Engineer. This position will report directly to the Manager, Quality Engineering. This is an onsite role in West Hills, CA with an approximate duration of two to four months.
Primary Responsibilities:
Compensation for the role will depend on several factors, including a candidate's qualifications, skills, competencies, and experience.
Salary Range
$60-$70 USD
ImmPACT Bio provides a generous Total Rewards package, to include a competitive base salary, bonus, and equity package as well as generous benefits and paid time off programs. ImmPACT Bio is an Equal Opportunity Employer and will review all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. All information will be kept confidential according to EEO guidelines.
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