Sr. CQV Engineer - Thousand Oaks, CA

VTI Life Sciences•Thousand Oaks, CA

4d•$90,000 - $120,000•Onsite

About The Position

VTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their careers in the pharmaceutical, biotechnology, and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industry. We are looking for a Senior CQV Engineer to support a VTI client project in Thousand Oaks, CA. We need a Sr. CQV Engineer with experience developing, executing, and reporting CQV protocols (IQ, OQ, PQ) for utility, HVAC, filling, and packaging systems.

Requirements

Bachelor’s degree or higher in Engineering, Chemistry, Pharmaceutical Sciences, or a related scientific field.
Minimum 7+ years of experience in the Biotechnology or Pharmaceutical industries
Strong technical writing and protocol/report development skills.
Ability to interpret complex data and resolve validation issues.
Effective communication and cross-functional collaboration skills.

Nice To Haves

Proficiency with validation lifecycle management systems and quality management systems (TrackWise, Kneat, Veeva, etc., a plus).

Responsibilities

Develop and execute CQV protocols, reports, and risk assessments in accordance with client procedures and cGMP, FDA, EMA, and other regulatory guidelines.
Coordinate validation activities with Manufacturing and QA to ensure proper execution.
Investigate and support the resolution of protocol deviations and nonconformities.
Support change control activities related to system and equipment modifications.
Write and maintain SOPs related to system and equipment operation and maintenance.
Ensure documentation meets internal quality standards and audit readiness.