Validation Engineer/ Specialist
The Validation Engineer/ Specialist will be responsible of all validation activities for the assigned project. This project include 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.