CQV Validation Engineer, Biotech GMP Equipment – Remote (JP15497)

3 Key Consulting•Thousand Oaks, CA

6d•Remote

About The Position

Primarily responsible for planning, coordinating, executing, and documenting periodic reviews of GMP equipment to ensure continued state of validation, compliance with regulatory requirements, and suitability for intended use. The role partners with Engineering, Manufacturing, Quality Assurance, Validation, and Maintenance teams to assess equipment performance, maintenance history, calibration status, deviations, change controls, and overall lifecycle management.

Requirements

Demonstrable experience in a pharmaceutical, biotech, or life science organization in a C&Q/CQV/validation maintenance role.
Knowledge of cGMP commissioning/qualification/validation practices.
Familiarity with biotech/pharmaceutical manufacturing equipment.
Familiarity with Kneat Gx Platform or other digital C&Q systems.
Experience working with cross-functional stakeholders.
Knowledge of quality assurance principles including deviations and change control systems.
Effective communication skills, both verbal and written.
Able to think analytically with the ability to resolve issues.
Able to manage own time efficiently.
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

Nice To Haves

Short tenures at previous jobs (<2 years)
No experience in commissioning/qualification/validation

Responsibilities

Execute periodic reviews of GMP equipment according to approved procedures and schedules.
Assess equipment records including work orders, deviations, and change control records.
Evaluate equipment records to verify continued fitness for intended use.
Generate and/or revise periodic review reports.
Collaborate with Manufacturing, System Owners, Validation, and Quality teams as needed.
Schedule and lead review meetings as needed to resolve issues.
Ensure reviews are completed within established timelines and regulatory expectations.
Maintain periodic review trackers and metrics.
Identify opportunities to improve the equipment periodic review process.
Other duties may be assigned to this role.