Validation Engineer

Commissioning Agents, Inc.
San Francisco and Boston

Commissioning Agents, Inc. is a 100% employee-owned past winner of the ISPE Company of the year award. We are a highly respected provider of technical services for biotech and pharmaceutical manufacturers world-wide. Our focus is on commissioning and validation, including factory inspections, construction quality assurance oversight, start-up/commissioning, and IQ/OQ/PQ. We provide commissioning/validation planning, management, field execution, and computer software development and validation (PLC, DCS, SCADA, database applications). CAI also has a select team that provides international regulatory compliance consulting and process improvement services, and LEED consulting.

Essential responsibilities are as follows and include development of documentation to support validation such as user requirements specifications, enhanced design review, commissioning protocols, and installation, operation and performance qualification protocols. The Validation Engineer/ Scientist/ Specialist will also be responsible for protocol execution and field verifications which may require climbing ladders, climbing around permanently installed equipment and entering confined spaces. The employee must protect proprietary information of the company and its customers from unauthorized persons. This position requires integrity, initiative, excellent written and oral communication skills, the ability to learn and work in a fast paced environment, and knowledge of good documentation practices.

Requirements: Excellent oral and written communication skills. Proficient in the use of Microsoft Office products. Ability to work independently and in a team environment. Be willing to work (compensated) overtime, including some weekends. Be able to pass random illegal drug screening. Ability to learn and work in a fast paced environment. Knowledge of good documentation practices. Willing to travel to meet project requirements We are seeking individuals with one or more of the following education and experience: Four-year degree in engineering or science. Experienced quality assurance supervisors or validation engineers. Former U.S. Navy nuclear-trained personnel, officer or enlisted. Experience testing process control systems.

www.commissioningagents.com