Job Description:
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 I to join our team at our project site near Lexington, Kentucky.
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.
Additional Responsibilities
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Write C/Q/V documents following established standards and templates, including but not limited to the following:
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Commissioning Forms
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C/Q/V Protocols and Summary Reports
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Standard Operating Procedures
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Impact Assessments
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Specifications (URS/FRS/DDS)
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FATS/SATs
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Perform field/site activities, including, but not limited to, the following:
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Attend and witness FATs and SATs as a representative of IPS clients.
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Execution of commissioning forms and witnessing of vendor start-up and testing.
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Execution of C/Q/V protocols.
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Walkdown and verification of system drawings (P&IDs, as-builts, etc.)
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Compile data and prepare reports for completed C/Q/V activities, including ETOPs, protocol data packages, etc.
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Assist in deviation investigation and resolution of problems and issues encountered during field execution activities.
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Work with the Project Delivery department or CM for start-up and vendor testing. Witness and troubleshoot as required.
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Primary responsibilities include C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries.
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Read, understand, and utilize the IPS Best Practices and SOPs for the delivery of compliance services
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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.
Qualifications & Requirements:
- Bachelor of Science in Engineering.
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0-2 years of relevant experience.
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Experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or
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QA.
Preferred Qualifications
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Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment, Systems, and Software.
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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.U. and U.S. FDA.
Physical Demands
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Must be able to: stand, sit, and walk for prolonged periods, stoop, kneel, crouch, and crawl as required.
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Must be able to lift and move objects weighing up to 50 pounds and climb ladders as necessary.
Work Environment
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Can work in both indoor and outdoor environments, which may include exposure to varying working conditions.
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Can adhere to strict cleanroom gowning protocols.
Travel
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This position will have up to 100% travel, or as required by the assigned project.
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Position may be assigned to the client site for an extended period of time.
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Overnight travel or staying in the city of the Client’s location is possible, depending on the assignment.
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Travel will be per the IPS Travel Policy, client-specific travel policy, or project-specific travel plan.
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Must have access to reliable transportation.
Safety
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This position is a safety-sensitive position.
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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.
All interviews are conducted either in person or virtually, with video required.
About Us:
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. Integration is how we think and work. 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. We meet our clients where they are and get them to where they need to go. That’s only possible when we care as much as our clients do.
Specialties
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.
All qualified applicants will receive consideration for employment at IPS without regard to race, creed, color, religion, national origin, sex, age, disability, sexual orientation, gender identity or expression, genetic predisposition or carrier status, veteran, marital, or citizenship status, or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer.
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