3key Consulting, Inc.
Validation Engineer, Biotech Facilities & Engineering (JP13959)
3key Consulting, Inc., Thousand Oaks, California, United States, 91362
Overview
Job 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 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 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 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:
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. Interested candidates should send their resume to recruiting@3keyconsulting.com. For other positions, visit www.3keyconsulting.com/careers or share this opportunity with others who might be interested.
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Job 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 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 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 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:
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. Interested candidates should send their resume to recruiting@3keyconsulting.com. For other positions, visit www.3keyconsulting.com/careers or share this opportunity with others who might be interested.
#J-18808-Ljbffr