Validation Engineer II

IPS is searching for a Validation Engineer II for the Indianapolis, IN office. This person will perform cGMP compliance based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS’ clients. Will follow IPS and client standards and requirements, overall good industry practices for C/Q/V services and regulatory requirements. May also perform standalone commissioning services for non-FDA regulated clients.

Job Duties and Responsibilities

• Write C/Q/V documents following established standards and templates.
• Perform field/site activities such as: attend and witness FATs and SATs as a representative of IPS clients, execution of commissioning forms and witnessing of vendor start-up and testing, execution of C/Q/V protocols, walkdown and verification of system drawings.
• Compile data and prepare reports for completed C/Q/V activities including ETOPs, protocol data packages, etc.
• Assists in deviation investigation and resolution for problems and issues encountered during field execution activities.
• Coordinate with the Project Delivery department or CM for start-up and vendor testing. Witness and troubleshoot as required.
• C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries.
• Read, understand and utilize the IPS Best Practices and SOPs for delivery of compliance services.
• Provide consistent, complete and timely feedback and reports to IPS project leaders, project managers or management of project status and issues.

Professional and Educational Requirements

• Bachelor of Science in Engineering is required for an Engineer; Bachelor of Science in a related field is required.
• 2 or more years of industry experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA. Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms and protocols for GMP Utilities, Equipment, Systems, and Software.
• General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validate processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA.
• Proficiency with Microsoft Office applications.
• Experience with Cleaning, Process, Computer System, Methods, and other validation activities and processes, beneficial.
• Experience with Risk-Based Approach to Commissioning and Qualification beneficial.