Validation Engineer II

Mangan, Inc • Cary, NC

1d • Remote

About The Position

Mangan, Inc. is seeking a Validation Engineer II in Durham, NC. This role is responsible for executing validation projects for equipment, facilities, and utilities within a pharmaceutical manufacturing, packaging, or support environment. The engineer will coordinate execution efforts with various departments including operations, manufacturing, facilities, laboratories, development, materials management, and quality assurance. Key responsibilities include analyzing validation data, preparing summary reports, and providing recommendations for improvements in manufacturing processes and equipment. The role also involves developing training packages, Job Safety Analyses (JSAs), and writing Best Known Methods (BKMs) for Validation. The Validation Engineer II will act as a liaison between validation and manufacturing, identify and monitor project risks, and develop contingency plans. Additionally, they will review technical and quality system documents such as SOPs, Change Control and Deviation Reports, Batch Production Records, Technical Manuals, P&IDs, and various diagrams related to validation principles and regulatory compliance.

Requirements

• Bachelor’s degree (or foreign degree equivalent) in Engineering, Science, or a related technical field.
• 2 years of experience as a Validation Engineer, Automation Engineer, Technical Writer, or a related occupation in an Equipment Qualification in Biotechnology or Pharmaceutical GMP environment.
• Demonstrated experience in developing Engineering Lifecycle Documents (URS, FRS, DDS, FRAs) and Validation Protocols (IQ, OQ, PQ, AIQ, VSR, PVP).
• Demonstrated experience with change control processes in the pharmaceutical industry.
• Demonstrated experience with 21CFR 210, 211, and Part 11.
• Demonstrated experience with Data Integrity Requirements for Electronic Records and Signatures per 21CFR Part 11.
• Demonstrated experience performing validation activities for SCADA, WinCC OA, and PI tags for Building Automation Systems and Environmental Monitoring Systems.
• Demonstrated experience developing and executing FATs, SAT, and Startup testing for automated systems.
• Must have legal authority to work in the U.S.

Responsibilities

• Execution of validation projects for equipment, facilities, and utilities in a pharmaceutical manufacturing, packaging, or support environment.
• Coordinate execution efforts with operations, manufacturing, facilities, laboratories, development, materials management, and quality assurance personnel.
• Analyze validation data, prepare summary reports, and provide recommendations for improvement in manufacturing processes and equipment.
• Develop training packages, JSAs, and write Best Known Methods (BKM) for Validation.
• Serve as a dependable liaison between validation and manufacturing.
• Identify, respond to, and monitor potential project risks and determine possible contingency plans for risk mitigation.
• Review technical and quality system documents such as SOPs, Change Control and Deviation Reports, Batch Production Records, Technical Manuals, P&IDs, construction, as-built, and flow diagrams as they relate to validation principles and regulatory compliance issues.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level