Validation Engineer II

Overview

Perform cGMP commissioning, qualification & validation services for pharma/biotech projects.

Key Responsibilities

• commissioning
• drawing review
• c/q/v
• fat/sat witness
• data reporting
• vendor testing

Tasks

-Execution of commissioning forms and witnessing of vendor start-up and testing. -Perform field/site activities including, but not limited to, the following: -Walkdown and verification of system drawings (P&IDs, as-builts, etc.) -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. -Execution of C/Q/V protocols. -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. -Read, understand, and utilize the IPS Best Practices and SOPs for the delivery of compliance services -Attend and witness FATs and SATs as a representative of IPS clients. -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. -Assist in deviation investigation and resolution of problems and issues encountered during field execution activities. -Compile data and prepare reports for completed C/Q/V activities including ETOPs, protocol data packages, etc. -Write C/Q/V documents following established standards and templates, including but not limited to the following: -Work with the Project Delivery department or CM for start-up and vendor testing. Witness and troubleshoot as required.

Requirements

• gmp
• validation
• iq/oq/pq
• pharmaceutical
• bs engineering
• 2+ yrs

What You Bring

-Overnight travel or staying in the city of the client’s location is possible depending on the assignment. -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. -C/Q/V Protocols and Summary Reports -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. -2+ years of relevant work experience. -Experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA. -Specifications (URS/FRS/DDS) -Bachelor of Science in Engineering.

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Benefits

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

About Ips-Integrated Project Services

-Founded with the vision of delivering exceptional project solutions, the company is a trusted partner in the global construction and engineering sector. -From concept to completion, the company offers comprehensive services across various industries, including industrial, energy, infrastructure, and commercial sectors. -The company has a rich history of delivering large-scale, complex projects, with a focus on high-quality standards, safety, and sustainability. -Specializing in end-to-end project delivery, the company ensures that projects are managed efficiently, from initial planning through to construction and commissioning. -Notable for its ability to handle both small-scale and large-scale ventures, the company is recognized for its expertise in managing projects for major players in energy and industrial markets. -The company's deep technical expertise allows them to bring innovative solutions to life, working across sectors like nuclear, water resources, and heavy civil engineering. -With a solid track record in the design and build of cutting-edge facilities, the company stands out for its dedication to technical excellence and client satisfaction.

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