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 c

GMP, 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.