Senior MES Analyst – Permanent – Portsmouth, USA

Location:                                                              Portsmouth, USA

Salary:                                                  Hourly Rate Open/Flexible

Stat Date:                                                            ASAP

Roles & Responsibilities

• Define User requirement specifications (Voice of customer)
• Design and create electronic batch files (EBR) with respect for quality, costs and deadlines
• MBR / BOM/ Recipe creation in production on IT systems
• Participate in the qualification on and risk assessment processes
• Propose and technically validate the choice of solutions proposed by the IT teams and Automation on in collaboration on with the Quality team
• Participate to the deployment of MES across the manufacturing units, runs performance qualification on and validation on batches (commissioning of the line) with the manufacturing units
• Responsible for the manufacturing documenta on update following the implementation on of electronic batch files
• Provide training for MES users in partnership with the training team
• Ensure follow-up and processing of deviations and Change Control in compliance with deadlines and applicable regulations
• Real time shop floor troubleshooting with the implementation on of appropriate immediate corrective actions
• Ensure the transfer of information to production teams following issues or modifications having a technical, quality or HSE impact
• Responsible for MES / MIS technical knowledge transfer to the shop floor
• Ensure the preparation of audits and inspections for related topics
• Collaborate with process experts in the context of deviations related to MES / MIS and - continuous process improvement
•  Participate to change management in close collaboration with change champion and P&O partner
• Ensure the application of local rules, procedures and policies for the site setup

Candidate Requirements

• Minimum of 4-8 Years’ experience in a similar role, ideally in the pharmaceutical industry.
• BOP/RTE configuration in Syncade software is a must.
• Subject Matter Expert for MES (Sycade) production IT systems
• Exposure to DeltaV Recipe Design will be an added advantage
• Expertise in Recipe Design, Syncade, OSI-PI, Interface with SAP and Trackwise
• Experience with OSI PI System
• Understanding of Pharmaceutical or Biopharmaceutical process
• Understanding of L2 interfaces and integration with MES
• Familiarity with SDLC and quality management processes in the pharma industry
• Ability to work well in a Team environment
• Able to manage multiple party coordination for MES information