Job ID - 2101

Location: Remote US United States Illinois

Employment Type: Permanent

Role

Zenith Technologies, a Cognizant Company transforms Life Sciences manufacturing with a focus on delivering speed to value now. We provide scalable end-to-end smart factory solutions, from conception through to completion, across the manufacturing lifecycle. We are a single solution provider for all GMP Manufacturing systems, specialising in delivery and support of automation, MES and digital technologies. We manage, control and optimise pharma & biotech production, to deliver on the promise of Pharma 4.0, creating robust systems with maximum operational efficiency, resilience and compliance. Together with our clients, we deliver life-changing medicines to patients who need them most. We are looking for an MES Validation Engineer to be remote based anywhere in the US.

MES Validation Engineer

Role Description

• Lead qualification of POMSNet (MES) Manufacturing Execution System and associated outbound and inbound system
• Maintain validation philosophies, master plans and procedures required to drive the validation lifecycle of production recipes
• Work in conjunction with Validation team, BTS, Production, Manufacturing Engineering and Quality Assurance to manage program and strategies aligned with site validation philosophies
• Establish validation plans commensurate with the level of risk and manage the execution of validation projects whose scope, regulatory visibility, schedule requirements, and complexity require coordination with customers, collaborators, and quality
• Responsibilities include oversight of validation execution work arising from change controls, capital projects, and shutdown/changeover activity.
• Responsible to deliver validation projects under strict deadlines to ensure customer success and bulk drug supply. This includes the establishment of plans, protocols, test scripts, risk assessments, and summary reports.
• Participate in various client discussions to address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiencies.

Experience

• BS in Computer, engineering, mechanical, electrical engineering, chemical bio-engineering or relevant discipline is required
• Minimum of 5 + years of experience with MES (Manufacturing Execution Systems) (POMSNet or FTPS etc.,) pharmaceutical process systems executing design, commissioning, troubleshooting activities is required
• Working knowledge of cGMP type systems and practices is required
• Strong foundation of Industrial Automation and Manufacturing IT Systems
• Computer System Validation (CSV) Experience 5+