Cleaning Validation Engineer II
Gilead Sciences
16 days ago
On-site
La Verne, CA
Operations
Knowledge & Skills:
- Understanding and application of validation principles, concepts, practices, and industry standards.
- Working knowledge of current Good Manufacturing Practices (cGMPs) and regulatory requirements.
- Familiarity with equipment, utility systems, facility operations, and automation systems.
- Strong investigation and troubleshooting skills.
- Good verbal, written, and interpersonal communication skills.
- Proficient in Microsoft Office applications.
Key Responsibilities:
- Perform validation activities for equipment, utilities, facilities, processes, and/or automation systems per approved SOPs, cGMPs, and regulatory requirements.
- Lead and execute cleaning validation for a multi-product facility (parenteral and solid dose).
- Execute validation protocols and test plans (sample collection, data recording, results documentation).
- Compile/analyze/interpret validation data; prepare reports and recommend improvements.
- Investigate/ troubleshoot validation deviations or failures; identify root cause and corrective actions.
- Coordinate validation-related change control (draft protocols/reports/data summaries).
- Maintain compliant validation documentation/records; author/revise validation procedures/protocols/technical documents.
- Coordinate/oversee contractors and external resources.
- Collaborate with cross-functional teams (Manufacturing, Quality, Engineering).
- Provide day-to-day guidance/training to validation technicians and junior staff.
- Serve as technical resource for validation inquiries.
- Resolve moderately complex validation issues with limited supervision, ensuring compliance and data integrity.
- Experience with recovery studies and cleaning validation in GMP environments.
- Hands-on swabbing execution for cleaning verification and monitoring.
- Occasionally support night/weekend/off-shift schedules.
Basic Qualifications:
- Bachelor’s degree in a science or related field + at least 4 years of relevant experience.
- OR Master’s degree (MS/MBA) + at least 2 years of relevant experience.
Benefits:
- Eligible employees may participate in company-sponsored medical, dental, vision, and life insurance plans (subject to plan terms).
Application:
- For current employees and contractors, apply via the Internal Career Opportunities portal in Workday.
- Understanding and application of validation principles, concepts, practices, and industry standards.
- Working knowledge of current Good Manufacturing Practices (cGMPs) and regulatory requirements.
- Familiarity with equipment, utility systems, facility operations, and automation systems.
- Strong investigation and troubleshooting skills.
- Good verbal, written, and interpersonal communication skills.
- Proficient in Microsoft Office applications.
Key Responsibilities:
- Perform validation activities for equipment, utilities, facilities, processes, and/or automation systems per approved SOPs, cGMPs, and regulatory requirements.
- Lead and execute cleaning validation for a multi-product facility (parenteral and solid dose).
- Execute validation protocols and test plans (sample collection, data recording, results documentation).
- Compile/analyze/interpret validation data; prepare reports and recommend improvements.
- Investigate/ troubleshoot validation deviations or failures; identify root cause and corrective actions.
- Coordinate validation-related change control (draft protocols/reports/data summaries).
- Maintain compliant validation documentation/records; author/revise validation procedures/protocols/technical documents.
- Coordinate/oversee contractors and external resources.
- Collaborate with cross-functional teams (Manufacturing, Quality, Engineering).
- Provide day-to-day guidance/training to validation technicians and junior staff.
- Serve as technical resource for validation inquiries.
- Resolve moderately complex validation issues with limited supervision, ensuring compliance and data integrity.
- Experience with recovery studies and cleaning validation in GMP environments.
- Hands-on swabbing execution for cleaning verification and monitoring.
- Occasionally support night/weekend/off-shift schedules.
Basic Qualifications:
- Bachelor’s degree in a science or related field + at least 4 years of relevant experience.
- OR Master’s degree (MS/MBA) + at least 2 years of relevant experience.
Benefits:
- Eligible employees may participate in company-sponsored medical, dental, vision, and life insurance plans (subject to plan terms).
Application:
- For current employees and contractors, apply via the Internal Career Opportunities portal in Workday.