CQV Engineer II

IPS-Integrated Project Services • Emeryville, CA

300d • $87,300 - $116,400

About The Position

At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a talented CQV Engineer II to join our team at our office located in _____________. In this role, you will perform cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS clients. You will also follow IPS and client standards and requirements, overall good industry practices for C/Q/V services, and regulatory requirements. You may also perform standalone commissioning services for non-FDA-regulated clients.

Requirements

• Bachelor of Science in Engineering.
• 2+ years of relevant work experience.
• Experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA.

Nice To Haves

• Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/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/Validation processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA.

Responsibilities

• Write C/Q/V documents following established standards and templates, including but not limited to the following: Commissioning Forms, C/Q/V Protocols and Summary Reports, Standard Operating Procedures, Impact Assessments, Specifications (URS/FRS/DDS), FATS/SATs.
• Perform field/site activities including, but not limited to, the following: 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 (P&IDs, as-builts, etc.), Compile data and prepare reports for completed C/Q/V activities including ETOPs, protocol data packages, etc.
• Assist in deviation investigation and resolution of problems and issues encountered during field execution activities.
• Work with the Project Delivery department or CM for start-up and vendor testing. Witness and troubleshoot as required.
• Primary responsibilities include 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 the delivery of compliance services.
• 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.

Benefits

• Salary offered for this role is between $87,300-$116,400, but actual salary offered is dependent on experience, skill set and education.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree