Packaging Engineer I

At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads 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 were 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

We are looking for a Packaging Engineer I who will interface with vendors to develop alternate designs of packaging components and translate into actionable specs.

Responsibilities:

• Lead packaging development activities for clinical programs ensuring alignment with product requirements regulatory expectations and global standards.
• Apply sound engineering principles and industry standards (e.g. USP ISO ASTM) to the design and qualification of container closure systems (CCS).
• Author and execute packaging studies including protocols and reports for component qualification shipping validation and compatibility assessments.
• Conduct and support equipment and process qualification activities (IQ/OQ/PQ) for packaging lines and configurations at internal and external manufacturing sites.
• Ensure packaging components and systems comply with current Good Manufacturing Practices (cGMP) and applicable regulatory guidelines.
• Investigate and resolve packaging-related deviations non-conformances and complaints in collaboration with Quality and Operations teams.
• Support regulatory submissions by authoring and reviewing relevant sections of INDs NDAs BLAs and other global filings.
• Maintain and author SOPs related to packaging development and ensure alignment with broader organizational procedures.
• Collaborate with external partners including CMOs suppliers and test laboratories to ensure timely and compliant execution of packaging activities.
• Travel up to 25% may be required to support project execution at external sites.
• With guidance may participate on cross-functional project teams to help meet complex project deliverables such as new product launches or start-up of new manufacturing/packaging sites.
• With guidance performs fairly routine tasks to aid technical investigations and assessment of deviations particularly as related to data generation/gathering and analysis.
• Prepares required engineering and manufacturing documentation for revision and approval by manager/supervisor.
• Works on assigned projects through completion with limited direct supervision.
  Interfaces with production sites to improve/optimize current production processes.

Basic Qualifications:

• Masters OR
• Bachelors and 2 years of relevant experience OR
• Associate and 4 years of relevant experience OR
• High School Diploma/GED and 5 years of relevant experience

Preferred Qualifications:

• Good verbal written and interpersonal communication skills are required.
• Normally receives limited instructions on routine work and general instructions on new assignments.
• Works on problems of a routine to basic scope where analysis of data requires evaluation of identifiable factors.
• Specific education and experience requirements:
  BS or MS degree in a science field preferably in an engineering field or a related technical discipline.
  
  
  

For additional benefits information visit:

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

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