Validation Engineer

Performs cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS’ clients. Follows IPS and client standards and requirements, overall good industry practices for C/Q/V services and regulatory requirements. May also perform standalone commissioning services for non-FDA regulated clients. Write C/Q/V documents following established standards and templates, including but not limited to the following: Commissioning Forms Perform field/site activities including, but not limited to, the following: Execution of commissioning forms and witnessing of vendor start-up and testing. 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. Primary responsibilities include 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. Provide consistent, complete, and timely feedback and reports to IPS project leaders, project managers, or management, of project status and issues, as requested. REQUIRED EDUCATION/QUALIFICATIONS /WORK EXPERIENCE Associates or bachelor’s degree in related field preferred. Entry level position. 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/protocols for GMP Utilities, Equipment, Systems, and Software a plus. 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 E.This position will have up to 100% travel to site, or as required by the assigned project. Position may be assigned to client site for an extended period of time. Overnight travel or staying in the city of Client’s location is possible depending on assignment. Travel will be per the IPS Travel Policy, client specific travel policy or project specific travel plan. Position will visit Client sites and will be required to adhere to stated safety rules. Position may visit active construction sites and will be required to take site safety training and adhere to site safety rules. 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. Proficiency with Microsoft Office applications (Word, Excel, Project, Powerpoint, etc). Personal skills and traits include: Excellent customer service skills Supports and deploys technical training programs that assure competency and advancement levels to support corporate goals. Promotes a friendly and efficient work environment, which rewards achievement and recognizes teamwork and champion’s technical advancement, which supports our corporate goals. Must strive for excellence in all aspects of job performance. Must approach their work enthusiastically with a contagious energy and drive that shows everyone they love what they do. All interviews are conducted either in person or virtually, with video required . IPS , a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services. disability; veteran, marital, or citizenship status;