Validation Engineer II

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

Knowledge:

• Understanding and application of validation principles, concepts, practices, and standards.
• Working knowledge of current Good Manufacturing Practices (GMPs).
• Working knowledge of equipment and systems.
• Working knowledge of industry practices.
• Good verbal, written, and interpersonal communication skills are required.
• Investigation skills.
• Proficient in Microsoft Office applications

Specific Education & Experience Requirements:

• 4+ years of relevant experience and bachelor's degree in science or related field.
• 2 + years of relevant experience and a MS or MBA.

Specific Job Responsibilities:

• Responsible for performing validation of Analytical/QC Instruments, equipment, utility systems, facilities, processes and/or automation systems by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements.
• Executes test plans according to approved procedures, collects samples, tabulates test results, and organizes data packages.
• Compiles and analyzes validation data, prepares reports and makes recommendations for changes and/or improvements.
• May also investigate and trouble-shoot problems which occur, and determine solutions.
• Oversees and co-ordinates the vendor execution for the QC instruments.
• Coordinates and executes validation change control and preparation of draft protocols, risk assessments, summary reports and data tables.
• Maintains all documentation pertaining to validation.
• May assist in developing procedures and/or protocols.
• Coordinates contract personnel through completion of assignments.
• Works on cross-functional project teams as required.
• May provide day-to-day guidance and training to other validation technicians.
• Serves as an information resource to validation technicians, contractors and vendors.
• Resolves validation issues of moderate scope with limited supervision.

About Gilead:

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.