Validation Engineer Specialist

Overview

The Validation Engineer / Specialist will be responsible for all validation activities for the assigned project. This project includes the validation of multiple autoclaves and Temperature controllers. Validation Scope may include : Validation Life Cycle, Execution, Technical Documentation, Process, GAP Analysis, Risk Assessment, C&Q activities, among others.

Qualifications

• Bachelor degree in Engineering or Science
• 5 to 10 years of experience required in the medical device, biotechnology or pharmaceutical industry (liquid dosage a PLUS).
• MUST have experience validating autoclaves
• Experience with Validation Life Cycle (Process, Packaging and Cleaning).
• Experience and knowledge in regulations, including GMP.
• Experience developing and conducting efficient processes to meet production demands.
• Excellent technical writing and verbal communication skills are required.
• Excellent detail oriented individual who can identify milestones.
• Great interpersonal and communications skills.
• Able to interact with all areas and clients.
• Proficiency utilizing MS Office Suite (Word, Excel and PowerPoint) is required.
• Available to work extended hours, holidays if require.
• Must be available to travel and work non-standard shifts if necessary.
• Only candidates who qualifies with all requirements will be evaluate.
• Bilingual (Spanish & English) a plus but not necessary.

Additional Information

Validation and Engineering Group, USA Inc. is an Equal Employment Opportunity employer.

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