Computer System Validation Professional
Commissioning Agents, Inc. - Chicago, IL

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COMPANY OVERVIEW

Commissioning Agents is a leader in establishing new, practical approaches and standards for industry to better deliver and operate manufacturing facilities. Our clients have projects with schedule pressures, financial constraints, business/ energy challenges, and regulatory compliance requirements. When one or more of our employees serve as part of such a project team, the project will have a significantly greater chance of success.

Commissioning Agents has been the standard by which all other similar service providers are judged. We continue to strive for excellence, providing quality teams based on the strength of our corporate reputation.

Commissioning Agents’ employees are well-qualified consultants, engineers or technical specialists. Our employees are highly motivated individuals who are willing to go the extra mile to help our clients achieve their project objectives. We offer our employees a balance of quality of life, financial gain and security, and professional advancement and achievement, and as a result, we offer highly motivated professionals for our clients.

Purpose:

To establish the validation strategies and plans for all software systems and to ensure the validation deliverables for software systems meet the quality standards and requirements of our clients and FDA regulations.

Essential Functions:

- Review configuration of and change requests for software and automation systems including:
- Delta-V PCS, SCADA, LIMS and BMS for quality impact
- Determine re-validation or validation review requirements
- Review all validation documentation such as Validation Plan, URS, Functional Requirements,
Design Document, IQ/OQ and associated test scripts, and Validation Summary Packages, Software/Hardware Design, Functional or Software Acceptance Test protocols
- Review computer system change control and provide testing guidance
- Identify and report possible exceptions to SOP’s
- Identify and report possible preventive and corrective actions
- Identify and report potential hazards either safety or ergonomic
- Identify and report safety and environmental hazards
- Identify exceptions associated with validation protocol execution
- Analyze validation data and report results

Minimum Requirements:

- Bachelor’s degree in electrical engineering, computer science or IT or equivalent experience
- 2-4 years information technology and/or pharmaceutical industry experience
- 2 years experience performing testing and system validation work in a cGMP environment
- Must possess excellent technical writing, documentation and communication skills
- Familiarity with FDA requirements for computerized systems, including 21 CFR Part 11 as well as GAMP guidance documents
- Strong attention to detail, quality oriented
- Ability to integrate teams of IT personnel including but not limited to internal and external staff

Benefits

You will be paid at an hourly rate commensurate with education and experience, with time and a half over 40 hours per week. The company provides health insurance for you and your dependents, continuing professional education, paid time off, and a generous retirement contribution. Please provide professional references with resumes.

Qualified candidates must be legally authorized to be employed in the United States. CAI does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position


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