MES Engineer / PharmaSuite Consultant

MES Engineer / PharmaSuite Consultant (Onsite – Parsippany, NJ)

We are currently looking for an experienced MES Engineer / Rockwell PharmaSuite Consultant to join an urgent project with a leading client in the Life Sciences Manufacturing industry in the United States.

This is an onsite role based in Parsippany, New Jersey, requiring daily presence at the client site.

Key Responsibilities

• Review, analyze, and understand current (“As-Is”) and future (“To-Be”) business process flows and URS documentation provided by Business and MES SMEs
• Build and update design specifications and related validation documentation in collaboration with the CSV Lead
• Coordinate approvals with relevant stakeholders
• Configure MES solutions and L2 (Automation) interface tags as required
• Develop FTPS Procedure Templates and Master Recipes
• Perform demos and informal verification of recipes in Development/Sandbox environments
• Update recipes based on business feedback and evolving requirements
• Create and maintain OQ protocols
• Prepare and execute test scripts, supporting validation and CSV activities
• Follow up with stakeholders for reviews and approvals
• Support updates to CSV documentation including VP, FS, DS, OQ, PQ, TM, and validation reports
• Assist Business and Site IT teams in migrating recipes to Quality and Production environments
• Support OQ/UAT, PQ activities, and Go-Live execution
• Deliver training to Super Users and SMEs using a Train-the-Trainer approach
• Provide hypercare support for eBR-related production issues
• Conduct Knowledge Transfer (KT) sessions with MES support teams post-hypercare

Required Skills & Experience

• Strong experience with Rockwell PharmaSuite MES
• Experience in Life Sciences / Pharmaceutical Manufacturing environments
• Hands-on experience with MES recipe design, configuration, testing, and deployment
• Good understanding of CSV and validation processes
• Experience preparing and executing OQ/PQ documentation and test scripts
• Ability to work closely with Business, IT, Automation, and Validation teams
• Strong communication and stakeholder management skills

Location

• Onsite in Parsippany, NJ
• Candidates must be able and willing to work at the client site daily

Start Date

• Urgent requirement / Immediate availability preferred