Edison-New Brunswick Metro Area, NJ
The Validation Engineer supports the successful implementation of manufacturing and laboratory equipment and computerized systems at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role, contributes to the completion of milestones associated with equipment qualification and systems validation. With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited scope. As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization.
Knowledge, Skills & Abilities:
Strong working knowledge of MS Windows client and server 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
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.
Technical / Professional Knowledge
Problem Solving / Troubleshooting
Attention to Detail
Education & Experience:
BS degree in Engineering or equivalent
Minimum 5 years of experience in FDA-regulated industry, with 5 years experience in CSV
Environment may include working in office or in a laboratory / manufacturing area.
Ability to work safely in an environment with hazardous, radioactive, and infectious materials and waste.
Ability to work safely when working alone, or working with others.