Associate Validation Engineer

Associate Validation Engineer 

Contract: 6 + months duration with possible extensions

Location: Lake Bluff, IL - ONSITE

ASI is looking for an Associate Validation Engineer who will handle the development and the execution of projects which include engineering studies, validation protocols and re-validations of manufacturing facilities, equipment, utilities, computerized systems, cleaning methods, and processes. The general validation activities include research, protocol writing/execution, specifically laboratory equipment, manufacturing equipment validation, water filtration, cleaning validation, and product validation. Additionally, investigations of manufacturing challenges are conducted, and process improvements are evaluated/implemented. 

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Essential Duties and Responsibilities:

• Be involved in design of experiments, development of new methodologies and improving existing methodologies, data generation, report development and presentation.

• Schedule, plan, communicate, and manage documents and follow-up on validation activities. 

• Interpret and apply regulatory requirements concerning validation activities.

• Perform validation activities to lead and/or support cleaning, equipment, computer systems, utility, facility, and method validations.

• Review and generate quality documents including validation protocols, SOPs, change controls, and non-conformance event records as required.

• Ability to follow good project management practices to meet schedules while ensuring compliance with procedures and regulations.

Education and Experience Requirements:  

• BS Degree in Science, Engineering or Math, prefer new grads with science or engineering degrees.
• Basic knowledge of GMP and basic understanding of validation and pharma guidelines.
• At least 1 year experience in the pharma industry and validation experience is preferred.

Qualifications:

• Experience with writing and executing validation protocols is preferred. 
• Knowledge and understanding of cGMPs, industry guidance and aseptic techniques.
• Understanding of statistical analysis tools and methods.
• Understanding scientific strategies and be able to invent new methods of investigation.
• Good interpersonal/communication/influencing/negotiation skills.
• Ability to communicate effectively at all levels in verbal and written form, including technical/business writing.
• Proficient in Microsoft Word and Excel, computer software. 
• Ability to work independently or in teams.