What are the responsibilities and job description for the Digital Quality, IT Project Manager Manufacturing Execution Systems (MES) position at Shimento, Inc.?
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.