<p>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.</p> <p>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.</p> <p>We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.</p> <p>Job Description</p> <p>Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. Our manufacturing facility located in La Verne, California is currently seeking a highly motivated and knowledgeable individual to join the team as a Manufacturing Engineer III with a focus on providing automation support for process equipment, including manufacturing operational support and process optimization. This role would be the primary automation support for Flexible Filling Line 3, an isolator filling line for manufacturing clinical and commercial products.</p> <p>Extensive knowledge of control layer hardware and programming is strongly preferred. Additionally, as all systems are interfacing to the GMP network, the individual should be well versed in FDA Code of Federal Regulations Title 21, Part 11, Computer Systems Validation, GAMP, Data Integrity Compliance, and GMP change management procedures. The individual will be expected to use Maximo, ValGenesis, and Veeva Vault systems to facilitate development of documentation, standard operating procedures, work orders, and change management records in line with automation system maintenance and enhancements.</p> <p>Key Responsibilities</p> <p>Process and Design Optimization:</p> <ul> <li> <p>Develop, design, and optimize processes for process equipment ensuring efficiency and cost-effectiveness while maintaining the quality of the product.</p> </li><li> <p>Evaluate recommended upgrades to replace aging, inefficient, and discontinued equipment/components.</p> </li><li> <p>Analyze process data to identify inefficiencies, bottlenecks, or areas of improvement on process equipment and processes supporting process equipment.</p> </li><li> <p>Monitor key performance indicators (KPIs) and recommend adjustments and improvements to meet targets.</p> </li><li> <p>Collaborate with the cross-functional teams to troubleshoot issues and drive continuous improvement.</p> </li><li> <p>Implement process optimization strategies to increase productivity and reduce costs.</p> </li><li> <p>Ensure compliance with safety, environmental and regulatory standards.</p> </li><li> <p>Support continuous improvement initiatives of the LV site such as Lean or Six Sigma methodologies.</p> </li><li> <p>Prepare, create, and review technical documentation, including process flow diagrams, standard operating procedures (SOP), and reports.</p> </li></ul> <p>Troubleshooting and Problem Solving:</p> <ul> <li> <p>Support manufacturing operations in areas related to the automation of the process equipment, including cross-functional communication and coordination to resolve issues, and providing automation technical expertise for real-time troubleshooting, investigations, and training.</p> </li><li> <p>Collaborate with engineers (manufacturing, facilities, automation, etc.), technicians, and management to integrate new technologies or equipment.</p> </li><li> <p>Conduct risk assessments and develop mitigation plans for process improvements.</p> </li><li> <p>Prepare, create, and review technical documentation.</p> </li><li> <p>Support root cause analysis (e.g. A3) for equipment related issues and implement correction plans with the cross functional team.</p> </li></ul> <p>Capital Projects, Capability Expansions, and New Product Introduction (NPI)</p> <ul> <li> <p>Support the installation and startup of equipment expansions or new equipment.</p> </li><li> <p>Support the NPI group as an automation SME for process equipment for tech transfers to the process equipment.</p> </li></ul> <p>Basic Qualifications</p> <ul> <li> <p>6+ years of relevant experience and a BS or BA or related fields OR</p> </li><li> <p>4+ years of relevant experience and a MA or MBA.</p> </li><li> <p>Has previous experience in biotech or pharmaceuticals industry.</p> </li><li> <p>Has previous experience in engineering in highly regulated manufacturing environments.</p> </li></ul> <p>Preferred Qualifications</p> <ul> <li> <p>Has experience with automated infrastructure that include: security strategies, network architecture, platform selection, and full implementation of 21 CFR Part 11 and EU Annex 11 requirements.</p> </li><li> <p>Has experience with Rockwell Software suite: FactoryTalk View, FactoryTalk Historian (OSI PI Historian), FactoryTalk Transaction Manager, FactoryTalk AssetCentre.</p> </li><li> <p>Has experience with SQL Database and Reporting.</p> </li><li> <p>Has experience with Stäubli Robotics.</p> </li><li> <p>Has extensive experience in PLC hardware programming (ControlLogix).</p> </li></ul> <p>The salary range for this position is: $115,260.00 - $149,160.00. 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*.</p> <p>For additional benefits information, visit:</p> <p>https://www.gilead.com/careers/compensation-benefits-and-wellbeing</p> <ul> <li>Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. </li></ul> <p>For jobs in the United States:</p> <p>Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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.</p> <p>For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.</p> <p>NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT</p> <p>YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT</p> <p>PAY TRANSPARENCY NONDISCRIMINATION PROVISION</p> <p>Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.</p> <p>Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.</p> <p>For Current Gilead Employees and Contractors:</p> <p>Please apply via the Internal Career Opportunities portal in Workday.</p>