Sr. Validation Engineer II

Role Summary

Sr. Validation Engineer II at Gilead. Contributes to validation activities across clinical and commercial manufacturing, leading investigations, CAPAs, and technical assessments to ensure quality and compliance in aseptic manufacturing environments.

Responsibilities

• Contributes directly to the completion of projects through the development of validation schedules, project plans, master plans, validation protocols and reports for systems that may be complex in nature to support clinical and commercial manufacturing.
• Works independently to resolve moderately complex to complex validation issues with very limited direct supervision.
• Conducts and serves as a lead/coordinator of investigations and corrective and preventative action (CAPA) recommendations related to distribution and validation activities.
• Provides technical assessment and approval for engineering and process changes.
• Forecast external support requirements for continuous validation support, including implementation of new projects.
• Coordinates the activities of assigned validation and contract personnel, ensuring the quality of completed work.
• Prepares regulatory submissions and presents validations to regulatory authorities during routine internal and pre-approval inspections.
• Provides relevant CMC support for pre- and post-approval filings.
• Leads standardization and harmonization of Standard Operating Procedures, leveraging existing Gilead Quality Systems.
• Work with Quality to adopt an effective quality management system and achieve the quality objectives.
• Able to implement new technologies, programs or initiatives.
• Provide leadership for Validation team and ensure growth and development of staff to meet changing business needs.

Qualifications

• Knowledgeable of the principles of GxPs.
• Expertise in aseptic manufacturing principles, including production of complex injectable formulations, contamination control, cleaning validation and isolator technology.
• Injectable product experience (biologics or pharmaceutical) required.
• Must have in-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally.
• Demonstrate extensive knowledge of industry best practices and trends.
• Able to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories.
• Able to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovation.
• Able to exercise judgment and independently determine and take appropriate action where precedent may not exist.
• Excellent verbal, written, and interpersonal communications skills are required.
• Demonstrate ability in managing competing priorities, creating an effective team environment.
• A bachelor‚Äôs degree in science, engineering or a related field with a minimum of eight (8) years of relevant experience or master‚Äôs degree in science, Engineering or a related field with a minimum of six (6) years of relevant experience.

Skills

• Validation planning and execution
• CAPA investigations and regulatory interactions
• Regulatory submissions and CMC support
• Quality systems and SOP standardization
• Project leadership and cross-functional collaboration

Education

• Bachelor‚Äôs degree in science, engineering or related field (8+ years) or Master‚Äôs degree (6+ years) in science, Engineering or related field.