Validation Engineer - Pharma Equipment - Engineering Resource Group

Description

• Permanent position for a Validation Engineer for pharmaceutical manufacturing equipment and controls.
• Primary responsibility is preparation of validation protocols (IQ/OQ) and commissioning documents for company equipment and control systems.
• Work with company's control system programmers to develop and execute factory acceptance software test documents.
• Work as an integral member of a project team.
• Interface with the company equipment manufacturing companies and internal departments to obtain the equipment, controls, and installation support documents necessary for protocol development.
• Field execution and testing of approved validation protocols (IQ/OQ) and commissioning documents. This will include (but is not limited to) I/O forcing, alarm testing, sequence testing, PLC diagnostics, and PID loop performance testing.
• Coordinate the efforts of the personnel involved during on-site qualification.
• Specify, obtain, and maintain hardware and software necessary to perform in-house and on-site validation testing.
• Prepare documents of field visits in a timely and professional manner, including field reports, daily labor logs, invoices, and expense reports.
• Keep current with latest cGMP's, Validation technology and procedures, ISPE guidelines and related FDA publications.
• Develop, maintain, and enhance positive interpersonal relationships with staff members.

Requirements

• BS Engineering or Science
• Minimum 5 years of related experience.
• Must posses a valid driver's license.
• Confined space entry training is required for potential entry into confined spaces within company supplied equipment.
• Must have the ability to develop validation protocol (IQ and OQ), validation reports, and factory acceptance test documents. As such, good writing and grammar skills and attention to detail asre essential.
• Experience is required in reading and interpreting electric and pneumatic controls, technical design documents, and PLC code.
• Travel 25 to 35% to customer sites to perform validation testing of company equipment and control systems.
• Familiarity with industry accepted practices for documenting test results, recording of deviations, and deviation resolutions.
• Must have excellent communication skills and be comfortable presenting the validation results to our customer's project team (QA, validation, project management, etc.).
• Must have good troubleshooting skills. Prior experience in control system programming, commissioning, calibration, I/O forcing, PID loop tuning, and/or equipment service is desirable.
• Must be willing and be capable to climb ladders and to enter restrictive spaces.
• Must have an understanding of computer system validation including knowledge of GAMP 5 and CFR 21 Part.

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