Sr. Process Engineer I (MES)

Gilead; United States; Remote; USD 100,000 - 150,000; Full time

Job summary

Gilead is seeking a skilled project lead to oversee and enhance implementation strategies for commercial and clinical cell therapy products. This role is pivotal for ensuring project deliverables align with quality standards, requiring strong expertise in computer validation and leadership capabilities. Join a pioneering team dedicated to combating major health challenges through innovation.

Qualifications

• Expert knowledge in computer validation requirements and MES design.
• Possess experience in quality systems change management.

Responsibilities

• Oversee project implementation for cell therapy products.
• Ensure timely completion of project deliverables and quality records.
• Collaborate with stakeholders to resolve implementation issues.

Skills

Team Leadership

Project Management

Computer Validation

Quality Assurance

Risk Management

Job description

At Gilead Sciences Canada Inc., we are proud to be recognized as one of Greater Toronto’s Top Employers for 2024. Click here to learn more about why Gilead Sciences Canada is a top employer!

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, working tirelessly to develop therapies that improve lives and ensure access worldwide. We continue to combat 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 seek passionate, ambitious individuals eager to make a meaningful impact.

We believe every employee deserves excellent leadership. Our People Leaders are central to shaping our culture and fostering an inclusive, empowering environment where everyone can grow and fulfill their aspirations. Join Gilead and help us create possibilities together.

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 early, investigating and troubleshooting design and strategy issues.
• Lead discussions to enhance PAS-X functionality and streamline GMBR to meet multi-jurisdictional and multi-product needs.
• Engage in global initiatives and align MES strategies across sites.
• Prepare business case presentations for cross-functional site and global teams.
• Follow up on system errors with site, global owners, and vendors.
• Support change management activities related to quality systems (CCs, CAPAs, IAs).
• Collaborate with stakeholders to resolve implementation issues.
• Explore new MES functionalities and strategies for manufacturing support.
• May serve as Business Process Owner for MES.
• Support audits, inspections, and responses to regulatory commitments.
• Identify training needs and recommend improvements.
• Perform additional duties as assigned, delegating as appropriate.

Current Gilead employees and contractors should apply via the Internal Career Opportunities portal in Workday.