Job Description:
At IPS, you will apply your knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to pharmaceutical, biotech, and animal health research and manufacturing facilities. We are looking for a CQV Engineer to join our team in Dublin, Ireland.
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.
Position 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, 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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C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries.
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Perform work to meet IPS budget requirements and quality standards.
Qualifications & Requirements:
- Bachelor of Science in Engineering.
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5 or more years of relevant experience.
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Experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA.
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General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical
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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Design/Build/Commission/Validation processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA.
Context, Environment, & Safety
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This position will have up to 100% travel, as required by the assigned project.
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The position may be assigned to the client site for an extended period. The position will visit Client sites and will adhere to stated safety rules.
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The position may visit active construction sights and will take site safety training.
This position is a safety-sensitive position. 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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