Manufacturing Tech III

Responsibilities

• Perform routine to moderately complex manufacturing operations in compliance with SOPs, MBRs, and cGMP standards .
• Execute operations across multiple unit processes, including aseptic processing, dispensing, compaction, granulation, milling, and coating .
• Assemble, disassemble, and operate aseptic filling equipment and lyophilizer autoloading systems in classified cleanroom environments.
• Prepare equipment and components for sterilization , including operation of:
• Autoclaves
• Ovens
• Vial washers
• Depyrogenation tunnels
• Perform clean-in-place (CIP) and sterilization-in-place (SIP) of tanks and equipment, as well as manual cleaning and assembly.
• Conduct sterile filtration and annealing processes .
• Operate downstream equipment, including vial cappers , and support unloading and packaging of product from lyophilizers and fill lines .
• Perform Oracle and MES transactions to support production and resolve inventory discrepancies.
• Maintain manufacturing areas in a clean and compliant state , including walls, ceilings, and floors.
• Complete and maintain accurate GMP documentation , including logbooks, batch records, and reports.
• Support MBR updates and batch documentation activities.
• Dispense raw materials and manage batch preparation activities .
• Operate solid dose equipment , including drum coaters and compression machines.
• Perform manual material handling , including loading/unloading of tablets and product.
• Create purchase orders for consumables as needed.
• Provide regular updates to the Team Lead on line performance, issues, and deviations .
• Perform independent troubleshooting of moderately complex equipment and process issues.
• May serve as a point of contact during compliance audits .

Requirements

• High School diploma with 3+ years of relevant manufacturing experience.
• FETAC Level 6 (GSL) Certificate or equivalent technical certification.
• Prior experience in a cGMP-regulated industry is required.
• Shift:
• Night Shift- 4p-4:30a Sunday, Monday, Tuesday and every other Wednesday
• 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.
• For jobs in the United States:

Benefits

Additional Information

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. 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. Job Description Knowledge & Skills: Working knowledge of Standard Operating Procedures (SOPs) and Master Batch Records (MBRs) . Strong understanding of cGMP requirements and regulated manufacturing environments. Good verbal, written, and interpersonal communication skills . Proficiency in Microsoft Office applications and familiarity with administrative systems. Ability to follow direction while working independently with minimal supervision . Demonstrated capability to train and mentor others on manufacturing processes (e.g., filling, hydration, coating, granulation, compression). Ability to coordinate and organize complex manufacturing activities .

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