CQV Engineer - Thousand Oaks, CA - Onsite

Job description:

Seeking experienced and ambitious engineering professionals looking to advance their careers within the pharmaceutical, biotechnology, and medical device industries. We support some of the leading organizations across the Life Sciences sector, working alongside highly experienced subject matter experts on technically complex and high-impact projects.

We are currently seeking a Senior CQV Engineer to support a client project based in Thousand Oaks, California. This position requires a highly experienced CQV professional with a strong background in developing, executing, and reporting qualification and validation protocols, including IQ, OQ, and PQ activities across utility, HVAC, filling, and packaging systems.

PROJECT OVERVIEW

• Experience Required: Minimum 3+ years of CQV experience within the pharmaceutical or biotechnology industries
• Project Duration: Approximately 6 months
• Schedule: 40 hours per week, Monday-Friday
• Location: 100% onsite in Thousand Oaks, CA
• Candidates must be locally based or able to commute to the client site

RESPONSIBILITIES

• Develop, execute, and document CQV protocols, reports, risk assessments, and supporting validation documentation in accordance with client procedures and applicable cGMP, FDA, EMA, and regulatory requirements.
• Lead and coordinate validation activities with Manufacturing, Quality Assurance, Engineering, and other cross-functional stakeholders.
• Investigate protocol deviations, discrepancies, and nonconformities and support their resolution through appropriate corrective actions.
• Support change control activities associated with modifications to equipment, systems, processes, and facilities.
• Develop, review, and maintain SOPs related to equipment and system operation, qualification, validation, and maintenance.
• Ensure all validation documentation meets internal quality standards and remains inspection and audit ready.
• Independently manage assigned validation activities while ensuring project timelines, quality expectations, and compliance requirements are met.

REQUIREMENTS

• Demonstrated ability to operate as an independent, senior-level contributor with minimal supervision and consistently deliver high-quality results.
• Bachelor’s degree or higher in Engineering, Chemistry, Pharmaceutical Sciences, or a related scientific or technical discipline.
• Minimum 3+ years of experience within the pharmaceutical or biotechnology industries.
• Minimum 2+ years of hands-on Packaging Validation experience.
• Strong experience with filling and capping processes, isolators, packaging systems, drop testing, and stress testing.
• Strong knowledge of CQV lifecycle activities, including IQ, OQ, PQ, protocol development, execution, deviation management, and final reporting.
• Excellent technical writing skills with experience producing clear, compliant validation documentation.
• Ability to analyze complex technical data, identify validation issues, and drive effective resolutions.
• Strong written and verbal English communication skills with the ability to work effectively across Engineering, Manufacturing, Quality, and Operations teams.
• Experience with validation lifecycle management systems and quality management systems such as TrackWise, Kneat, Veeva, or similar platforms is highly desirable.