Validation Engineer prepares all protocols and reports for validation work. Coordinates all validation activities by constant communication with affected departments and personnel; oversees and reviews validation area processes and procedures. Being a Validation Engineer may require a bachelor's degree. Typically reports to a manager or head of a unit/department. The Validation Engineer works on projects/matters of limited complexity in a support role. Work is closely managed. To be a Validation Engineer typically requires 0-2 years of related experience. (Copyright 2024 Salary.com)
Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
This engineering position supports manufacturing activities associated with cGMP equipment and facilities. The engineer works in partnership with the automation, maintenance, project management, corporate engineering, and manufacturing to develop and oversee the operation and reliability of equipment while driving safety and quality compliance. The engineer will support the department and capital projects and provide data to support business cases and long-term strategy.
The Engineer role will provide direct engineering technical support as follows:
Model leadership behaviors and positive values to create a positive working environment.
Be individually accountable for the consistent equipment performance
Be accountable for assigned deliverables on key capital projects
Suggest design modifications to address risks and design in quality and safety.
Provide oversight for verification deliverables developed by outsourced/contract verification staff.
Act as a liaison between Engineering and Quality Assurance during project planning, execution, and closeout
Ensure that validation protocols are executed and documented in accordance with cGMP good documentation and safety compliant practices.
Ensure safety during commissioning, validation, maintenance, and manufacturing activities
Related Activities:
Participate or lead, when required, multidisciplinary site teams, e.g. Cross Functional Team, Root Cause Analysis lead.
Support Lean Transformation and Excellence in Operations process improvement by leading, supporting, and documenting improvement opportunities to reduce cost, improve safety/quality, or improve speed.
Provide ad hoc technical support and guidance for manufacturing and maintenance
Provide coaching and guidance to project teams and engineers using risk-based approaches
Defend the equipment-specific calibration, maintenance, & validation as required during regulatory inspections
Participate in internal audits and assess in conjunction with quality assurance
Assist in developing and maintaining business metric performance
Preferred Qualifications / Skills / Experience
Bachelor's degree in engineering.
2 years of relevant work experience.
Direct experience with regulated environments (FDA, OSHA, EPA, etc.)
Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, clean utilities, facilities, instruments, and equipment
Experience implementing risk-based verification on major GMP process equipment / automation projects, including validation protocol development and execution.
Experience with combination product / medical device quality systems verification.
Process equipment knowledge basic principles of cell culture, fermentation, purification, filling
Process automation knowledge fundamental understanding of automation infrastructure
Knowledge of Delta V, Rockwell, and Plant Information Systems is a plus
Strong communication and technical writing skills.
Strengths in facilitation and collaboration / networking
Experience in developing SOPs and delivering training
Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making
Basic understanding of process improvement methodologies to mature and improve business performance (examples: PDCA, LEAN, Six Sigma, etc.)
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