Validation Engineer II

Description

• Write C/Q/V documents following established standards and templates, including but not limited to the following:
• Walkdown and verification of system drawings (P&IDs, as-builts, etc.)
• Read, understand, and utilize the IPS Best Practices and SOPs for the delivery of compliance services
• Assist in deviation investigation and resolution of problems and issues encountered during field execution activities.
• The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas.
• Work with the Project Delivery department or CM for start-up and vendor testing. Witness and troubleshoot as required.
• Attend and witness FATs and SATs as a representative of IPS clients.
• Execution of C/Q/V protocols.
• Compile data and prepare reports for completed C/Q/V activities including ETOPs, protocol data packages, etc.
• Perform work to meet IPS budget requirements and quality standards. Provide consistent, complete, and timely feedback and reports to IPS project leaders, project managers, or management, of project status and issues, as requested.
• Execution of commissioning forms and witnessing of vendor start-up and testing.
• You may visit active construction sites and will be required to take site safety training and adhere to site safety rules.
• Primary responsibilities include C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries.
• Perform field/site activities including, but not limited to, the following:

Requirements

• General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validation processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA.
• Overnight travel or staying in the city of the client’s location is possible depending on the assignment.
• 2+ years of relevant work experience.
• Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment, Systems, and Software.
• This position will have up to 100% travel to the site, or as required by the assigned project.
• C/Q/V Protocols and Summary Reports
• Bachelor of Science in Engineering.
• Experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA.
• Specifications (URS/FRS/DDS)

Benefits

• Travel will be per the IPS Travel Policy, client-specific travel policy, or project-specific travel plan.

Training + Development

Interview process

Visa Sponsorship

Security clearance