Validation Engineer Jobs

The Validation Engineer shall support projects north of Allentown, by functioning as a key contributor for strategy development and execution of development and process validation related to viral vaccine manufacture. They will provide input to industrialization strategies and rationale for critical process parameters. Additionally, will lead the development and validation, health authority inspections, and investigations. PLEASE NOTE THIS POSITION IS ON-SITE NORTH OF ALLENTOWN, PA

Responsibilities

• Input to design space / DOE studies through establishment of scale-up / scale-down parameters utilizing engineering fundamentals (mixing, mass / heat transfer, modeling, dimensionless parameters, etc.) and process control strategies.
• Support execution and documentation of engineering, development and/or validation studies and lead or supervise groups and/task force in the planning of engineering, investigational, definition, development and process validation runs.
• Write protocols, reports, procedures and memos as needed to support viral vaccine drug substance manufacturing activities (upstream processes, downstream purification, products and associated test methods) as they relate to engineering, investigational, definition, development and process validation runs.
• Partner with Engineering to ensure industrial implementation of process design, including review of engineering design documents, provide review and input to C&Q strategy and participating in testing of equipment.
• Provide technical assistance to manufacturing and quality operations for process troubleshooting improvement, technical transfer and health authority inspections to achieving site metrics (+QDCI).

Since 1993, Hyde E+C has worked as an integral part of project teams for clients and equipment vendors in the pharmaceutical and biopharmaceutical industries, resulting in the successful construction, commissioning and validation of facilities and equipment. As a member of the Hyde team, you will be responsible for providing state-of-the-art custom solutions to leaders in our industry. As we continue to grow our operations globally, we strive to hire the best talent—men and women dedicated to quality and innovation. We offer a collaborative culture, challenging projects, and excellent compensation and benefits.

You will find the following values reflected in our company:

• Family
• Integrity
• Adventure
• Respect
• Wisdom

Hyde Engineering + Consulting is an equal opportunity, affirmative action employer.

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