Apply to Senior CQV Engineer – GMP Equipment, Utilities & Facilities Qualification - (JP15486)

Job Title: Senior CQV Engineer – GMP Equipment, Utilities & Facilities Qualification - (JP15486)
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: 06/16/26
Pay Rate: $66 - $72/hour W2
Notes: Only qualified candidates need apply. Local, onsite at least 3 days weekly 8-5

3 Key Consulting is hiring a Senior CQV Engineer – GMP Equipment, Utilities & Facilities Qualification 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.

Why is the Position Open?
Planned Project.

Top Must Have Skills:

Experience in commissioning/qualification/validation
Experience in a GMP environment

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.
May include conducting validation maintenance activities including performing and scheduling periodic reviews.
Other duties may be assigned to this role.

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

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.

Red Flags:
Short tenures at previous jobs (?2 years), not local and not willing to relocate

Interview process:
1-2 Stages of interview | Video interview (Teams)

We 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.