Job Description The Validation Engineer will support the characterization of process optimization strategies and/or troubleshoot operational issues in the operations, manufacturing, pilot plant or capital projects environment. Apply basic engineering principles to the design and implementation of system modifications, experiments and or/ capital projects. Organize, analyze and present interpretation of results for operational issues to engineering projects of minor scope and complexity. Work with consultants, architects and engineering firms on the development of standard design documents. Qualifications • Working knowledge of pharmaceutical/biotech processes • Working knowledge with validation processes • Working knowledge with documentation in a highly regulated environment • Ability to operate specialized laboratory equipment and computers as appropriate. • Ability to interpret and apply GLPs and GMPs. • Ability to apply engineering science to production. • Able to develop solutions to routine technical problems of limited scope • Demonstrated skills in the following areas: o Problem solving and applied engineering. o Basic technical report writing o Verbal communication • Comprehensive understanding of validation protocol execution requirements. • Demonstrated Skills in the following areas: o Basic technical presentations o Personal Organization o Validation Protocol Writing o Dealing with and managing change o Technical (Equipment Specific) o Analytical Problem Solving o Computer Literacy • Specialized equipment/process expertise • In-depth knowledge of validation processes and requirements as applied to new equipment installations • Interacts effectively with variety of communication and working styles • Ability to independently determine when additional internal resources are required to solve problems • Ability to handle multiple projects at one time • Demonstrated Skills in the following areas: o Schedule development o Facilitation o Collaboration o Basic project management o Completion and follow-up • Established expertise in at least 3 separate areas of engineering technology. • Ability to independently determine when additional external resources are required to solve problems • Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope • Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach • Working knowledge of financial analysis tools • Ability to delegate and manage the project work of others • Demonstrated Skills in the following areas: o Negotiation, persuasion and facilitation o Collaboration o Project cost development o Conflict Resolution o Leadership and teambuilding • Basic knowledge in vision systems • Basic knowledge in equipment controls (PLC, HMI, Servodrives, etc) • Basic knowledge in Medical Devices or Combination Products • Basic knowledge in Lean Manufacturing, Six Sigma or Quality by Design • Basic knowledge in Statistics • Basic knowledge in Metrology • Basic knowledge in plastic molding process • Basic knowledge of medical device assembly process • Basic knowledge of packaging of medical devices or pharmaceutical products • Basic knowledge in Safety Training (MSDS, Equipment Safety, etc)
