Apply to Senior Validation Engineer, Biotech Facilities & Engineering (JP13958)

Job Title: Senior Validation Engineer, Biotech Facilities & Engineering (JP13958)
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: $60 - $70/hour (DOE) - W2 with benefits
Posting Date: 4/22/2025.

3 Key Consulting is hiring! We are recruiting a Senior 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.

Top Must Have Skill Sets:

Experience in a GMP environment
Experience generating C&Q protocols & executing C&Q protocols
7+ years of relevant experience

Day to Day Responsibilities:

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:
Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 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.