Digital Quality, IT Project Manager Manufacturing Execution Systems (MES)

Digital Quality, IT Project Manager Manufacturing Execution Systems (MES)

Duration: 6 - 12 months/Onsite role / Hybrid is likely okay, but final decision is with Manager

Location – Vacaville, CA

What you will do

• Validation Strategy: Create and maintain validation execution plans in line with project timelines, budgets, and client’s Quality Management System (QMS).
• MES Implementation: Lead the planning and execution of validation deliverables for MES system implementations and related recipe lifecycle management (PharmaSuite, Syncade, MODA-ES).
• Quality Representation: Act as the voice of QA in cross-functional teams, driving the strategy, execution, and implementation of CSV standards and Quality Compliance across the client’s global network.
• Testing & Execution: Ensure timely and compliant setup and execution of tests in Lonza’s Test Management System (Kneat); monitor progress in test script creation, execution, and review.
• Compliance & Guidance: Ensure compliance with cGMP and regulatory requirements (e.g., Swissmedic, FDA) by providing CSV guidance to project teams and assessing the impact of new regulatory guidance.
• Documentation & Review: Review and approve technical documentation, including CSV protocols, risk assessments, test scripts, and validation summary reports.
• Training & Advisory: Ensure project team members are trained on client IT requirements and advise teams on processes, standards, and procedures to follow.
• Data Integrity: Uphold data integrity principles in accordance with client policies; proactively evaluate, identify, and escalate risks to the data integrity process.
• Audit Support: Support audits, inspections, and process qualification activities, translating regulatory trends into actionable quality improvement projects.

What we are looking for

• Experience: Proven experience in Computer Systems Validation (CSV) within a pharmaceutical manufacturing environment, with specific expertise in MES systems.
• Education: Degree in Life Sciences, Engineering, Computer Science, or a related technical field.
• Technical Knowledge: Strong understanding of cGMP, GAMP 5, and regulatory requirements (FDA 21 CFR Part 11, EudraLex Annex 11); experience with PharmaSuite, Syncade, or MODA-ES is highly preferred.
• Software Proficiency: Proficient with electronic validation tools (e.g., Kneat) and standard Document Management Systems.
• Soft Skills: A proactive problem-solver with strong organizational skills and the ability to escalate issues effectively.
• Communication: Business fluency in English with the ability to harmonize standards across Global Quality, IT PMO, and IT CoE teams.
• Mindset: A collaborative professional who thrives in a project-based environment and takes personal accountability for quality outcomes.