Validation Engineer

Validation Engineer 

6+ months contract duration with possibility of extensions

Onsite – North Chicago, IL 

Sponsorship is not available for this role now or in the future

Automated Systems, Inc. is looking for a Validation Engineer with at least 1-year relevant experience in the Pharmaceutical Industry with one of our global client’s Pharmaceutical Manufacturing Facility located in North Chicago, IL. 

In this role, you 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 will 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. Final documents are archived and maybe included in or support A/NDA submissions, and made available as needed during FDA and client/customer compliance audits.

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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.

• Applies knowledge or quickly learn cGXPs, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate.

• 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.

• Serves as a project lead for projects of intermediate scope with cross-functional teams.

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

Education and/or Experience Requirements:  

• BS Degree in Science or Engineering with at least one or more years of experience.
• At least 1 year in the pharma industry and 1 year in validation is preferred.
• Knowledge and understanding of cGMPs, industry guidance and aseptic techniques.
• Understanding of statistical analysis tools and methods.

Qualifications:

• Direct experience with writing and executing validation protocols.

• Understand scientific strategies and be able to invent new methods or new avenues of investigation.

• Good interpersonal/communication/influencing/negotiation skills.

• Strong project management 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. Some experience with statistical software helpful.

• Direct or indirect industry knowledge.

• Ability to work independently or in teams.

Top Technical Skill Requirements: 

- Tech savvy person- hands on person, not afraid to learn or use computerized systems and equipment.

- Proficient in Word, Excel, and PowerPoint.

- Knowledge of GMP and understanding of validation and pharma guidelines.