Validation Engineer

Knowledge, Skills & Abilities:
• Strong working knowledge of MS Windows client and server technologies.
• Working knowledge of standard networking principles and technologies
• Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry
• Strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance
• Ability to work with the end user to identify and document User and Functional Requirements
• Knowledge of pharmaceutical laboratory and manufacturing systems.
• Experience executing equipment qualification documents
• Ability to interact effectively with laboratory, QA, and Facilities groups
• Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously
• Strong written and verbal communication skills along solid presentation skills. Proficient at writing well-formulated emails and reports. Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task. Ability to effectively communicate with employees, contractors and vendors. Experience with technical writing and document development / generation
• Strong computer skills in Microsoft Office Suite – Word, Excel, Visio and Outlook, and the ability to learn new software as required for equipment qualification.

Education & Experience:
• BS degree in Engineering / Computer Science or equivalent
• Minimum 5 years of experience in FDA-regulated industry, with 5 years experience in CSV