CQV Engineer

IPS-Integrated Project Services; Dublin; On-site; EUR 45,000 - 65,000; Full time

Job summary

A global technical consulting firm in Dublin is seeking a CQV Engineer to support compliance in pharmaceutical facilities. This role involves writing compliance documents, performing field activities, and compiling reports, requiring a Bachelor’s degree in Engineering and at least 5 years of relevant experience. The ideal candidate will have a strong understanding of GMP practices and engage in extensive travel as needed. Join this dynamic team to make a significant impact on project deliveries.

Qualifications

• 5 or more years of relevant experience.
• Experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA.
• General exposure and experience in a GMP/Validation discipline.

Responsibilities

• Write C/Q/V documents following established standards.
• Perform field/site activities and witness FATs/SATs.
• Compile data and prepare reports for C/Q/V activities.

Skills

cGMP compliance

Field/site activities

Pharmaceutical design and validation

Education

Bachelor of Science in Engineering

Job description

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 aCQV 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

• Write C/Q/V documents following established standards and templates, including but not limited to the following:
• Commissioning Forms
• C/Q/V Protocols and Summary Reports
• Standard Operating Procedures
• Impact Assessments
• Specifications (URS/FRS/DDS)
• FATS/SATs
• Perform field/site activities including, but not limited to, the following:
• Attend and witness FATs and SATs as a representative of IPS clients.
• Execution of commissioning forms, witnessing of vendor start-up, and testing
• Execution of C/Q/V protocols
• Walkdown and verification of system drawings (P&IDs, as-builts, etc.)
• 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. Witness and troubleshoot as required
• 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.

Come join a caring, nimble team that delivers world-class designs for our pharmaceutical clients and takes your career to new heights!

Qualifications & Requirements

• Bachelor of Science in Engineering.
• 5 or more years of relevant experience.
• Experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA.
• General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical

Preferred Qualifications

• Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment, Systems, and Software.
• 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

• This position will have up to 100% travel, as required by the assigned project.
• 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.
• 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. IPS 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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