Autoclave Validation Engineer

Validation & Engineering Group; Johns Creek (GA); In loco; USD 80.000 - 100.000; Tempo pieno

Descrizione del lavoro

A leading services supplier in Johns Creek, Georgia seeks a Validation Engineer to handle validation activities for multiple projects, particularly involving autoclaves and Temperature controllers. The ideal candidate has 5 to 10 years of experience in the medical device, biotech, or pharmaceutical industries, along with a Bachelor's degree in Engineering or Science. Strong communication and technical writing skills, as well as experience with Validation Life Cycle, are required. This role offers opportunities for extended hours and travel.

Competenze

• 5 to 10 years of experience required in the medical device, biotechnology or pharmaceutical industry.
• Experience with Validation Life Cycle including Process, Packaging, and Cleaning.
• Knowledge in regulations, including GMP.

Mansioni

• Responsible for all validation activities for assigned projects.
• Perform validation of multiple autoclaves and Temperature controllers.
• Conduct GAP Analysis and Risk Assessment.

Conoscenze

Validation of autoclaves

Technical writing

Interpersonal skills

Detail-oriented

Bilingual (Spanish & English)

Formazione

Bachelor's degree in Engineering or Science

Strumenti

MS Office Suite (Word, Excel, PowerPoint)

Descrizione del lavoro

Validation & Engineering Group USA (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.

Job Description

The Validation Engineer/ Specialist will beresponsible 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, biotechnologyor 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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