Sr. Process Engineer I (MES)

Gilead Sciences; Mississauga; On-site; CAD 70,000 - 85,000; Full time

Job summary

Gilead Sciences is seeking a Sr. Process Engineer I (MES) to lead project implementation for cell therapy products. The role requires expertise in computer validation and MES design, along with strong project management skills. Join a dynamic team making a difference in healthcare, contributing to innovative therapies combating significant health challenges.

Responsibilities

• Oversees project implementation for cellular therapy products.
• Responsible for training and coaching on batch record creation.
• Engage in global initiatives related to MES.

Skills

Project Management

Process Improvement

Change Management

Computer Validation

Job description

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At Gilead Sciences Canada Inc. we take pride in being recognized as one of Greater Toronto’s Top Employer 2024. Click here to find out why Gilead Sciences Canada is a top employer!

Chez Gilead Sciences Canada Inc., nous sommes fiers d’être reconnus comme l’un des meilleurs employeurs du Grand Toronto pour 2024. Cliquez ici pour en savoir plus sur les raisons de notre succès.

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

Responsibilities (included but are not limited to):

• Oversees a team responsible for leading and executing project implementation to support commercial and clinical cell therapy products
• Provide necessary training and ongoing coaching for batch record creation and validation requirements
• Responsible for deliverables and timely completion of projects. This includes quality records and project closure.
• Expert knowledge in computer validation requirements and MES design
• Ensure early visibility and awareness into implementation risks, identifying preventative measures, investigating, and troubleshooting design and strategy conversations.
• Lead discussions to improve PAS-X functionality and streamline the GMBR to meet multi-jurisdictional and multi-product and process improvement busineess needs
• Engage in Global initiatives and work on alignment with other sites related to MES
• Prepare business case presentations for projects to site and global cross-functional departments for alignment
• Responsible for follow up on system errors (including bugs) with site system owners, global owners, and vendor
• Strong understanding of change management to support changes in quality systems (CCs, CAPAs, IAs)
• Collaborate with technical and operational stakeholders to resolve implementation issues
• Explore new functionality and creative strategy for MES to support MFG processing
• May act as Business Process Owner for MES
• Supports audits and inspections
• Supports responses to regulatory commitments
• Identifies additional training or self-help improvement needs and communicates recommendations
• Additional duties as assigned.
• These duties can be delegated to designated deputies of a satisfactory qualification level as needed.
  
  

For Current Gilead Employees And Contractors

Please apply via the Internal Career Opportunities portal in Workday.

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Management and Manufacturing

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

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