Validation & Engineering Group, Inc. is a leading service supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, and Medical Devices industries in the following areas : Compliance, Quality, Engineering, Validation, Project Management, among other services in Puerto Rico and USA.
Main : Support Facilities, Utilities and Maintenance operations
Execute and conduct risk assessments.
Identify risk and ensure High and Critical Risks are communicated following procedures
Participate and lead mitigation initiatives.
Develop and maintain effective communication with the Risk Lead to ensure any deviation to the procedures are managed correctly.
Support the risk assessment documentation.
Provide expertise and recommendations in the selection of assessment methods.
Knowledge and experience with 21 CFR 4, 21CFR Part 820, EN ISO 14971, MDD 93 / 42 / EEC requirements.
Knowledge and experience with ISO 14971, ICH Q9 and 93 / 42 / EEC a PLUS!!!
Failure Mode and Effects Analysis, Preliminary Hazard Analysis, Hazard Analysis
Bachelor’s degree in Engineering (chemical, mechanical, industrial, electrical)
Minimum of 10 years of directly related experience (only resources with experience in the Biotechnology, Medical Devices and Pharmaceutical industries will be considered).
Familiar with the following standards : US Good Manufacturing Practices 21CFR820, cGMPs for Combination Products 21 CRF 4, Quality Management ISO 13845, EU Medical Device requirements Council Directive 93 / 42 / EEC, Medical Electrical Equipment EN 60601, Medical Device -
Software Life Cycle Processes - IEC / EN 62304 ( a Plus).
Failure Mode and Effects Analysis ( FMEA), Preliminary Hazard Analysis, and Hazard Analysis.
Strong Project management skills.
Excellent Technical writing skills.
Strong organizational skills.
Strong knowledge of and experience with processes involved in manufacturing and distribution.
Demonstrate ability to interact with all level of the organization.
Strong communication (both written and oral), facilitation and presentation skills.
Ability to evaluate compliance issues.
Available to work non-standard shifts requested and travel.
Bilingual (Spanish & English).
Validation and Engineering Group, USA, Inc is an Equal Employment Opportunity employer.