VALIDATION ENGINEER at Somerset

IPS is searching for a Validation Engineer for our Somerset, NJ office. Will perform cGMP compliance based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS’ clients. The Validation Engineer(s) will follow IPS and client standards and requirements, overall good industry practices and regulatory requirements. The individual(s) may also perform standalone commissioning services for non-FDA regulated clients.

 

Additional duties include:

• 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.

 Requirements

• Bachelor of Science in Engineering is required for an Engineer; Bachelor of Science in a related field is required.
• 5 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 EU and US 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 is beneficial.

 

IPS is an equal opportunity, affirmative action employer (M/F/D/V).

Country: USA, State: New Jersey, City: Somerset, Company: IPS - Integrated Project Services, Inc..