Senior CQV Engineer – Packaging Validation

Location

Thousand Oaks, California, United States

Salary

Not specified

Company

Akash pawar

Job description

• Role & Company / Project Overview Katalyst Pro / Katalyst CRO is seeking an experienced Senior CQV Engineer with strong Packaging Validation experience to support a pharmaceutical/biotechnology client project in Thousand Oaks, CA (W2). • Key Responsibilities & Daily Duties - Develop, execute, and document Commissioning, Qualification, and Validation (CQV) protocols and reports. - Lead validation activities with Engineering, Manufacturing, Quality Assurance (QA), and Operations teams. - Investigate deviations and support corrective actions. - Support equipment, system, and process change controls. - Develop and maintain validation-related Standard Operating Procedures (SOPs). - Ensure all documentation is inspection and audit ready. - Independently manage validation activities and project timelines. • Required Qualifications, Skills & Experience - 3+ years of CQV experience within the pharmaceutical or biotechnology industry. - 2+ years of hands-on Packaging Validation experience. - Strong knowledge of cGMP, FDA, EMA, and regulatory requirements. - Proven experience developing validation protocols, reports, risk assessments, and SOPs. - Experience with TrackWise, Kneat, Veeva, or similar validation/QMS platforms is highly desirable. - Strong technical writing and communication skills. - Bachelor's degree or higher in Engineering, Chemistry, Pharmaceutical Sciences, or a related technical/scientific field. • Working Hours, Shifts & Location Details - Location: Thousand Oaks, CA. - Employment arrangement: W2. • Application Instructions - Interested candidates are invited to connect or submit their resume for review.