Engineer III

About This Role

The Engineer III provides engineering technical support and validation for plant utilities and facilities. Participates in multi-functional teams to implement changes and improve on existing processes. This position partners with other teams including Utilities, Manufacturing, Process Engineering, Maintenance, and others to validate all GMP assets. Supports design, specification, installation, commissioning, and qualification of new equipment including URS and protocol writing and executions. Participates and leads engineering projects with minimal supervision and direction.

What You'll Do

• Supports Facilities operations by troubleshooting issues and identifying equipment system improvements. Updates standards, drawings, and specifications as necessary. Develops validation protocols, provides expertise to associated equipment & automation design modifications. Author deviations, CAPA’s and/or change control records in a GMP environment.
• Supports equipment related capital and op-ex projects, including scoping, modifications, design reviews, change controls, construction support, commissioning, and validation.
• Develops and executes equipment commissioning and qualification (validation) activities.
• Represent department and lead/participate in cross-functional/global teams to address issues, implement change and improve existing processes.
• Complete work tasks with oversight from Facilities Engineering Manager
• Manage small capital projects.
• Maintain personal training, goal development/completion, investigations, compliance workflow activities, and progress tracking.

Who you are

You are an experienced validation engineer who likes to lead development of IQ/OQ/PQ documentation. You are passionate about working in a cross-functional environment where you are facilitating validation project execution. You thrive in lending your expertise to others in the team. You are solution driven and enjoy continuous improvement. You easily recognize cost savings and pride yourself in driving safety enhancements. As a representative of the Facilities Engineering team you role carries the weigh of potential delays and extra resource allocation if errors occur in your decisions or recommendations.

Requirements

• BS in Engineering and 2+ years of transferrable experience.
• Practical knowledge of the application of FDA GMP and EMA regulations.
• Competency in MS Word, MS Excel, MS Power Point, MS SharePoint and MS Project
• Plant Utility and chamber Validation experience
• Excellent oral and written communication skills.
• May be asked to work extended shifts or weekends.

Preferred Qualifications

• Experience with Kaye and LIVES validation dataloggers.
• Experience in biotechnology/pharmaceutical manufacturing environment.
• Experience writing deviations and conducting investigations
• Project management experience