Sr. Process Engineer I (MES)

Gilead Sciences, Inc.; Ontario; On-site; CAD 80,000 - 110,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Manager to oversee project implementation for commercial and clinical cell therapy products. The role involves ensuring project deliverables, providing training, and collaborating with stakeholders to streamline processes. This position fosters an inclusive environment for personal and professional development.

Qualifications

• Expert knowledge in computer validation requirements.
• Strong understanding of MES design.

Responsibilities

• Oversees project implementation for cell therapy products.
• Provides training for batch record creation.
• Collaborates with stakeholders to resolve implementation issues.

Skills

Project Management

Change Management

Computer Validation

Collaboration

Education

Bachelor’s degree in a relevant field

Job description

Job Description

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

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 fulfill their aspirations. Join Gilead and help create possible, together.

Responsibilities (including but not limited to):

• Oversees a team responsible for leading and executing project implementation to support commercial and clinical cell therapy products.
• Provides necessary training and ongoing coaching for batch record creation and validation requirements.
• Responsible for deliverables and timely completion of projects, including quality records and project closure.
• Possesses expert knowledge in computer validation requirements and MES design.
• Ensures early visibility and awareness into implementation risks, identifying preventative measures, investigating, and troubleshooting design and strategy conversations.
• Leads discussions to improve PAS-X functionality and streamline the GMBR to meet multi-jurisdictional and multi-product and process improvement business needs.
• Engages in global initiatives and works on alignment with other sites related to MES.
• Prepares 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 vendors.
• Has a strong understanding of change management to support changes in quality systems (CCs, CAPAs, IAs).
• Collaborates with technical and operational stakeholders to resolve implementation issues.
• Explores new functionality and creative strategies for MES to support manufacturing 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.
• Performs additional duties as assigned, which can be delegated to qualified deputies as needed.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.

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Job Requisition ID R0045768

Full Time/Part Time: Full-Time

Job Level: Manager

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