Validation Engineer II

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. Join Gilead and help create possible, together.

Job Description

Responsibilities (include but are not limited to):

• Responsible for performing validation of 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.

• Coordinates and executes validation change control and preparation of draft protocols, reports and data tables.

• Maintains all documentation pertaining to validation.

• Develop 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 direct supervision.

Requirements:

• 4+ years of relevant experience and bachelor's degree in engineering or physical science or related field.

• 2+ years of relevant experience and an MS.

• Understanding and application of validation principles, concepts, practices, and standards.

• Working knowledge of current Good Manufacturing Practices (GMPs).

• Experience with qualification of aseptic processing equipment primarily Isolator, Filler, Lyophilizer and Tank SIP, Dry Heat (Depyrogenation Tunnel) and Moist Heat Sterilization (Autoclaves), general temperature mapping.

• 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.

• Be able to read and interpret drawings such as blueprints, PFDs, P&IDs.

The salary range for this position is: $97,495.00 - $126,170.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.