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Validation Engineer, Biotech Facilities & Engineering (JP13959)
Thousand Oaks, CA · Biotech/PharmaceuticalJob Title: Validation Engineer, Biotech Facilities & Engineering (JP13959)
Location: Thousand Oaks, CA. 91320
Business Unit: F&E Drug Product Supply
Employment Type: Contract
Duration: 1+ years with possible extension or conversion to FTE
Rate: $42 - $52/hour - W2 with benefits
Posting Date: 4/22/2025.
3 Key Consulting is hiring! We are recruiting a Validation Engineer for a consulting engagement with our direct client, a leading global biotechnology company.
Job Description & Responsibilities:
Key Skills and Requirements:
Basic Qualifications:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
Why is the Position Open?
Supplement additional workload on team
Interview Process:
Microsoft Teams followed by panel interview.
We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
Location: Thousand Oaks, CA. 91320
Business Unit: F&E Drug Product Supply
Employment Type: Contract
Duration: 1+ years with possible extension or conversion to FTE
Rate: $42 - $52/hour - W2 with benefits
Posting Date: 4/22/2025.
3 Key Consulting is hiring! We are recruiting a Validation Engineer for a consulting engagement with our direct client, a leading global biotechnology company.
Job Description & Responsibilities:
- Plan and track implementation of commissioning & qualification actions/documentation versus project(s) timelines.
- Author/evaluate qualification/validation protocols including DQ, IQ, OQ, FT, PQ protocols and final reports for new or modified GMP utilities, facilities, and process equipment.
- Execute DQ, IQ, OQ, FT, PQ protocols, which involve protocol discrepancies, investigation, and corrective action activities for new or modified GMP utilities, facilities, and process equipment.
- Ensure that Qualification/Validation plans are generated and updated for all ongoing projects.
- Prepare, evaluate and approve technical and GMP linked documentation such as URS, FMEA, impact/risk assessment, master plans, qualification/validation documentation.
- Arrange and implement FAT/SAT, commissioning activities for new GMP systems in collaboration with both internal and external partners.
- Other duties may be assigned to this role.
Key Skills and Requirements:
- Educated to a degree level in a technical or natural scientific field.
- Demonstrable experience in a pharma organization within a C&Q/CQV corresponding role.
- Knowledge of qualification needs to cGMP guidelines.
- Familiarity with Kneat Gx Platform or other digital C&Q systems.
- Familiarity working with cross-department stakeholders.
- Knowledge of quality assurance principles.
- Experience working within project teams and various projects in parallel.
- Prior involvement working with ISPE baseline guide vol 3, vol 4 and vol 5 would be beneficial.
- Effective communication skills, both verbally and in writing.
- Able to think analytically with the ability to resolve issues.
- Able to manage own time efficiently.
- Experience in a GMP environment
- Experience generating C&Q protocols & executing C&Q protocols
- Evaluating, assessing and modifying the existing test method, both their documentation and their implementation in the field.
- Creating new test methods and the required test fixtures.
- Creating all the required documents for qualification, validation and transfer of test methods.
- Create, revise parts and drawings using CAD software (SolidWorks Preferred).
- Perform data analysis using Minitab and interpret data.
- Performing and operating the tests required for qualification, validation and transfer of the methods.
- Creating training documents.
- Conducting the training and creating training reports and other documentations required for qualification, validation and transfer of the test methods.
Basic Qualifications:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
Why is the Position Open?
Supplement additional workload on team
Interview Process:
Microsoft Teams followed by panel interview.
We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
Regards,
3KC Talent Acquisition Team