Senior C&Q Validation Engineer – GMP Analytical & Process Equipment- (JP15147)

3 Key Consulting•Thousand Oaks, CA

13d•Hybrid

About The Position

3 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. This role is 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. The engineer will work with project teams and SMEs to develop testing strategies and participate in project meetings to inform stakeholders on the progress of C&Q activities.

Requirements

Demonstrable experience in a pharmaceutical, biotech, or life science organization in a C&Q/CQV role.
Knowledge of cGMP commissioning/qualification/validation practices.
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.
Experience in commissioning/qualification/validation.
Experience in a GMP environment.
Experience with analytical instruments (Benchtop laboratory equipment).
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.

Nice To Haves

Familiarity with Kneat Gx Platform or other digital C&Q systems.

Responsibilities

Lead and/or execute commissioning and qualification activities on new or modified GMP analytical and process equipment, utilities, and facilities.
Generate/review/execute C&Q protocols, plans, and summary reports.
Develop testing strategies with project teams and SMEs.
Participate in project meetings to inform stakeholders on progress of C&Q activities.
Plan and track implementation of commissioning & qualification actions/documentation versus project(s) timelines.
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.