Sr. Process Engineer I (MES)

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

Job summary

A leading biotechnology company is seeking a professional to oversee project implementation for commercial and clinical cell therapy products. This role requires strong leadership and expertise in computer validation, aiming to streamline processes and support cross-site initiatives. Join a pioneering team committed to developing life-changing therapies.

Qualifications

• Expert knowledge in computer validation requirements and MES design.
• Experience leading project implementations in clinical and commercial settings.
• Ability to identify and mitigate implementation risks.

Responsibilities

• Oversee team for project implementation of cell therapy products.
• Ensure timely completion of quality project deliverables.
• Lead efforts to improve PAS-X functionality.

Skills

Project Management

Computer Validation

Problem Solving

Collaboration

Training

Job description

At Gilead Sciences Canada Inc., we are proud to be recognized as one of Greater Toronto’s Top Employers 2024. Discover why Gilead Sciences Canada is a leading employer!

At Gilead, our mission is to create a healthier world for all. For over 35 years, we have tackled diseases such as HIV, viral hepatitis, COVID-19, and cancer by developing therapies that improve lives and ensuring access worldwide. We are committed to fighting major health challenges through collaboration, determination, and innovation.

Every member of Gilead’s team plays a vital role in discovering and developing life-changing scientific innovations. We value our employees as our greatest asset and are seeking passionate, ambitious individuals eager to make a meaningful impact.

We believe every employee deserves strong leadership. Our People Leaders are central to shaping our culture and fostering an inclusive, supportive environment where employees can grow and achieve their aspirations. Join Gilead and help us make the possible a reality.

Job Description

Responsibilities (including but not limited to):

• Oversee a team responsible for leading and executing project implementation to support commercial and clinical cell therapy products.
• Provide training and ongoing coaching on batch record creation and validation requirements.
• Ensure timely completion of project deliverables, including quality records and project closure.
• Possess expert knowledge in computer validation requirements and MES design.
• Identify and mitigate implementation risks, troubleshoot design and strategy issues.
• Lead efforts to improve PAS-X functionality and streamline GMBR processes to meet multi-jurisdictional and multi-product needs.
• Engage in global initiatives and align MES-related activities across sites.
• Prepare business case presentations for projects to site and global departments.
• Follow up on system errors, bugs, and coordinate with system owners and vendors.
• Support change management activities related to quality systems (CCs, CAPAs, IAs).
• Collaborate with stakeholders to resolve implementation issues and explore new MES functionalities.
• May serve as Business Process Owner for MES.
• Support audits and inspections, and respond to regulatory commitments.
• Identify training needs and communicate improvement recommendations.
• Perform additional duties as assigned, potentially delegated to qualified deputies.

For current Gilead employees and contractors, please apply via the Internal Career Opportunities portal in Workday.