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 (V&EG) is a leading services supplier 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.
Accountable to provide Quality oversight of FP Technologies method stewardship, modeling, and material characterization. Accountable to develop and lead a team that provides Quality technical expertise and assessments of compliance to FP Core Technologies and/or to sites. Ensures successful physical method development critical to achieving reliable data, considering impact of risk to patient, global compliance and time to market. Ensures alignment strategies for methods transfer across multiple sites. Works with External Supply Quality and/or other quality counterparts to ensure there is a robust plan in place when receiving methods from a CMO or supplier.
Provides Quality oversight to final product core technologies activities and deliverables
Quality approval of protocols and technical reports for method development
Masters/Bachelors Degree in Science or Engineering
Why is the Position Open?
additional workload on the team
Top 3 Must Have Skill Sets:
hard skills (5 years of experience)
Validation Qualifications experience
Combination process / Medical Devices experience
GMP experience (quality management systems, manufacturing)
Audits / Inspections experience
Top 3 Must Have Skill Sets:
hard skills (5 years of experience)
Validation Qualifications experience
Combination process / Medical Devices experience
GMP experience (quality management systems, manufacturing)
Audits / Inspections experience
Positions available for Puerto Rico.
Validation and Engineering Group, Inc. is an Equal Employment Opportunity employer.