The Validation Engineer will be responsible for ensuring that all manufacturing processes, systems, equipment, and products meet required regulatory standards, ensuring compliance with FDA, cGMP, and other applicable regulations. This role will work closely with cross-functional teams to develop, implement, and maintain effective validation strategies for new and existing processes.
Duties/Responsibilities:
• Serve as leader of assigned projects and manage a schedule and tracking daily progress
• Execute Validation activities on critical manufacturing equipment and utilities.
• Maintain full validation life cycle in a sterile/aseptic environment.
• Participate in Quality, Facilities, Operations, and/or R&D activities.
• Create and update asset management documents related to preventative maintenance and calibration requirements.
• Writing process, utilities, and validation procedures, writing reports, protocols, engineering studies, and processing action to be taken within the quality system.
• Lead and participate in validation efforts, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for new equipment and processes.
• Evaluate and recommend equipment and process improvements to enhance manufacturing efficiency and product quality.
• Participate in the lifecycle management of manufacturing assets, including planning for upgrades, replacements, and disposals in line with regulatory and operational needs.
• Responsible for projects throughout phases of the product lifecycle, including technology transfer, scale-up, development of user requirement specifications, process design, equipment and instrumentation specification / selection, equipment procurement, installation, commissioning, qualification, and turn-over to manufacturing.
• Design Engineering studies, process improvements, and equipment upgrades.
• Author, review and execute URS, FAT, SAT, IQ, OQ and PQ validation documentation.
• Ensure projects are completed using current regulations, cGMP, and internal policies and procedures.
• Use a risk-based approach to validation plans/management for new systems and equipment.
• Support Facilities, Metrology (Maintenance & Calibration) activities, as needed.
• Support projects via design input & support, change control implementation.
• Participate in investigations, root cause analysis and problem solving of raw materials, in-process and finished product with our supplier partners and team members.
Write and implement standard operating procedures to meet and maintain FDA cGMP, USP, and state licensure requirements.
• Must be a team player and effectively collaborate with internal departments.
• Excellent attention to detail.
• Experience in a regulated manufacturing industry.
• Demonstrates ability to handle multiple responsibilities at any given time.
REQUIREMENTS:
Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or a related field
. Minimum of 1+ years of experience in engineering within the pharmaceutical or biotech industry.
. Strong knowledge of cGMP regulations and FDA guidelines
. Excellent oral communication and technical writing skills.
. Experience with validation types: General equipment and facilities qualification, Temperature mapping of controlled spaces, Syringe, Bag, and line fill, Isolation equipment, Lab equipment qualifications, Computer & software system, Aseptic Media Fills, and Sterilization.