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US-MD-Gaithersburg: Automation Engineer

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Date: 03-Feb-2009

Automation Engineer II/III

POSITION FUNCTION: Provides support for all automation systems in a GMP environment in support of Biotech manufacturing. Supports automation system installations and modifications; including programming, writing specifications, performing testing, and maintenance of automation systems. Will be responsible for development of automated reports, automation SOPs and Requirement Specifications. Assist in the training of manufacturing personnel, maintenance technicians, and other engineers in the operation, maintenance, trouble shooting, and programming of automation systems. On call support and overtime will be required as needed.

EXPERIENCE (minimum requirements): Automation Engineer II - A minimum of seven years of job related automation experience, with at least four years of GMP experience in a pharmaceutical or biotech manufacturing environment. Experience with computerized system validation, GAMP, and CFR 21 part 11 required. Automation Engineer III - A minimum of ten years of automation experience, with at least six years of GMP experience in a pharmaceutical or biotech manufacturing environment. Experience with computerized system validation, GAMP, and CFR 21 part 11 required.

REQUIRED SKILLS: * Digital Control Systems (Rockwell and/or Delta-V experience preferred) * PLC systems and HMIs with emphasis on Allen Bradley systems * Digital Electronic Displays and Instrumentation * DH Network, Device Net, and (Wonder Ware and RSView) SCADA systems * Programming of PLC software and PID control loops * Maintaining the integrity of a software backup and control program * Ethernet networks and server maintenance * Excellent written and verbal communication skills * Good interpersonal communication skills * Proficient in computer skills and MS Office applications * Experience with OSI PI data historian would be preferred * Experience defending a computerized system during a regulatory audit would be preferred

EDUCATION (minimum requirements): A college degree and job related automation experience as outlined below. A control systems certification is desirable. Formal training in computerized system validation, GAMP, and CFR 21 part 11 would be preferred.

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Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com

US-MD-Gaithersburg: Automation Engineer