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.