Validation Engineering Manager

Validation Engineering Manager Job Opening in Roanoke, Virginia. A manufacturer and distributor of consumer goods is currently seeking to onboard a Validation Engineering Manager near Roanoke, Virginia. This Roanoke job would be well suited for an experience quality/validation professional with job experience developing validation master plans in a cGMP facility. This job offers competitive compensation and a good job benefits package.

Roanoke Validation Engineering Manager Overview:

The Roanoke Validation Engineering Manager shall develop a Master Validation Plan for the facility in order to ensure cGMP compliance. This Roanoke job will require a current and up to date knowledge of FDA/International cGMP standards. Previous experience developing such a plan is incumbent for this position.

Roanoke Validation Engineering Manager Job Opening

• The Validation Engineering Manager shall develop, implement, and update the Validation Master Plan for the manufacturing facility in greater Roanoke.
• Lead all validation studies. Implement corrective actions as necessary at the Roanoke site.
• The Validation Engineering Manager shall develop, implement, and update equipment and utility validation programs.
• Perform documentation studies which are aligned with FDA and international regulatory standards.
• The Validation Engineering Manager shall interface with manufacturing and quality control staff during all qualification studies in greater Roanoke, Virginia.
• Serve as project manager for equipment and utility validation studies. Develop a master plan for the project and direct project team members to follow that plan. Provide VP of Quality and Regulatory Affairs up to date plans, status reports, and a project summary.
• The Validation Engineering Manager shall organize qualification studies to be conducted by contractors or vendors while working out of Roanoke, Virginia. Check protocols and reports to ensure they comply with internal documentation and validation standards.
• Submit documentation to regulatory bodies, defend validation programs to agencies or client representatives during inspections.
• The Validation Engineering Manager shall monitor, direct, and coach all subordinates in the Validation department, particularly Document Control Specialists and Quality Engineers

Validation Engineering Manager (Roanoke Area) Job Requirements:

• A four year degree in a scientific or engineering discipline from an accredited institution is required for this job.
• A minimum of five years job experience in a quality management role in a cGMP environment.
• An understanding of FDA and internationals quality standards as well as industry practices related to equipment.
• Knowledge of FDA and international cGMP standards.
• Proven ability to develop, implement, and enforce a Validation Master Plan.
• Proven knowledge of IQ/OQ/PQ.
• Proven ability to perform evaluation studies on equipment and utilities.
• Proven ability to create protocols and develop efficient line trials during the product development process.
• Proven job experience leading teams through new product implementation processes, from conception through commercialization; meeting time, cost, and quality goals.
• Understanding of how to best utilize raw materials, production, quality assurance, costs, and other techniques to improve the manufacturing and distribution process.
• Proven ability to manage overlapping projects and personnel.
• Exceptional ability to analyze data.
• Understanding of statistical principles for quality checks.
• Strong communication skills, written and verbal.

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