Job Title: Senior C&Q Validation Engineer – GMP Analytical & Process Equipment- (JP15147)
Location: Thousand Oaks, CA. 91320 (Hybrid)
Employment Type: Contract
Business Unit: Engineering Systems
Duration: 1+ year (with likely extensions and/or conversion to permanent)
Posting Date: 03/31/26
Pay Rate: $60 - $65/hour W2
Notes: Only qualified candidates need apply. On site at least 3 days weekly 8-53 Key Consulting is hiring a
Senior C&Q Validation Engineer – GMP Analytical & Process Equipment for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description:Primarily responsible for leading and/or executing commissioning and qualification activities on new or modified GMP analytical and process equipment, utilities, and facilities. Responsibilities include generating/reviewing/executing C&Q protocols, plans, and summary reports. Works with project teams and SMEs to develop testing strategies. Participates in project meetings to inform stakeholders on progress of C&Q activities. Key skills include:
- Demonstrable experience in a pharmaceutical, biotech, or life science organization in a C&Q/CQV role.
- Knowledge of cGMP commissioning/qualification/validation practices.
- Familiarity with Kneat Gx Platform or other digital C&Q systems.
- Experience working with cross-functional stakeholders.
- Knowledge of quality assurance principles.
- Experience working within project teams and multiple projects in parallel.
- Effective communication skills, both verbal and written.
- Able to think analytically with the ability to resolve issues.
- Able to manage own time efficiently.
Why is the Position Open?Supplement additional workload on team
Top Must Have Skills:- Experience in commissioning/qualification/validation
- Experience in a GMP environment
- Experience with analytical instruments (Benchtop laboratory equipment)
Day to Day Responsibilities:- Plan and track implementation of commissioning & qualification actions/documentation versus project(s) timelines.
- Work with project teams to develop the commissioning and qualification strategy and document in qualification plans.
- Generate/evaluate qualification/validation protocols including IQ, OQ, FT, PQ protocols and final reports for new or modified GMP analytical and process equipment, utilities, and facilities.
- Execute IQ, OQ, FT, PQ protocols, which may involve protocol discrepancies, investigation, and corrective action activities for new or modified GMP analytical and process equipment, utilities, and facilities.
- 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.
- Develop and/or execute FAT/SAT and other commissioning activities for new GMP systems in collaboration with both internal and external partners.
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
Red Flags:Short tenures at previous jobs (-2 years), not local and not willing to relocate
Interview process: 1 video conference interview (Teams), potential follow-up interviewWe invite qualified candidates to send your resume to
resumes@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.