Validation Engineer

Overview

Perform cGMP compliance services including commissioning, qualification, validation.

Key Responsibilities

• field work
• walkdown
• issue resolution
• vendor testing
• c/q/v
• reporting

Tasks

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

Requirements

• gmp validation
• c/q/v
• microsoft office
• 2+ years
• b.sc engineering
• pharma experience

What You Bring

-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 -Proficiency with Microsoft Office Suite. -Overnight travel or staying in the city of the Client’s location is possible depending on the assignment. -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. -Experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA. -2+ years of relevant experience. -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.

Sector Specialisms

Interview Process

-interviews conducted in person or virtually, video required.

Visa Sponsorship

-no visa sponsorship will be provided.