Experienced in Validation and have a passion for Biotech? Take a closer look!
This Jobot Job is hosted by: Jenner Wiggins
Are you a fit? Easy Apply now by clicking the “Apply Now” button and sending us your resume.
A bit about us:
We are a immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancer and infectious diseases.
Why join us?
- Competitive Base Salary!
- Extremely Competitive Equity Package!
- Flexible Work Schedules!
- Accelerated Career Growth!
- Company Matched 401(k)!
Job Details
SUMMARY:
As our Validation Engineer you will be responsible for generating and executing protocols, creating summary reports and executing validation activities in FDA regulated biopharmaceutical environments.
MUST HAVES:
- IO, OQ, PQ Protocols
- Technical Writing
DUTIES & RESPONSIBILITIES:
- Generate and execute validation protocols (IQ/OQ/PQ) of all site equipment including laboratory equipment, production equipment, utilities (as applicable) and other related systems in an FDA regulated environment
- Author and review SOPs, protocols, reports, and validation master plans for GMP equipment, instruments, and computerized systems.
- Generate and keep current inventory of GMP systems and requalification/revalidation schedules
- Perform risk assessments for GMP systems as required. Plan validation efforts according to risk
- Collaborate with clients, CMOs, and vendors to meet project and company objectives
- Participate in audits and regulatory agency inspections for Validation
- Troubleshoot and coordinate failure investigations for manufacturing and laboratory equipment. Assist with vendor communications
- Resolve deviations and non-conformances reported during validation/qualification
EDUCATION & EXPERINCE:
- Bachelors in Biology, Chemistry, Chemical, Biochemical, or Mechanical Engineer
- GMP experience
- 2+ years of experience in a biopharmaceutical validation operations
- Experience with facility commissioning and validation of equipment and facilities
Interested in hearing more? Easy Apply now by clicking the “Apply Now” button.