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 out of our office in Dublin ,Ireland.

The CQV 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.

We rely on you to:

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.)
Compiles data and prepares reports for completed C/Q/V activities including ETOPs, protocol data packages, etc.
Assists with deviation investigations and helps to resolve problems and issues encountered during field execution activities.
Works with the Project Delivery department or CM for start-up and vendor testing. Witness and troubleshoots as required.
Primary responsibilities include C/Q/V of equipment and systems, including CSV and automation, supporting the pharmaceutical, biotech and medical device industries.
Reads, understands, and utilises IPS Best Practices and SOPs to deliver compliance services.
Special projects assigned.
Perform work to meet IPS budget requirements and quality standards. Provides consistent, complete, and feedback and reports to project leaders, project managers or management, of project status and issues.
Make recommendations to IPS for possible project and procedural improvements.
Support and provide guidance to entry level staff and colleagues throughout the delivery of C/Q/V services.
Stay current (training, reading, professional organization involvement) with industry trends and current C/Q/V methodologies.
Other duties as assigned.

IPS offers exciting growth opportunities! Come join a caring, nimble team that delivers world class designs for our pharmaceutical clients and take your career to new heights.

Qualifications & Requirements

Bachelor of Science or Engineering experience is required. Non-BSc / BEng degrees will be evaluated on a case-by-case basis.
Extensive experience doing Validation, Commissioning or QA work within the Life Science, Pharmaceutical, Biotech, Medical Device Design or Construction industries.
Experience writing and executing PFC, FC, IQ, OQ and PQ forms and protocols for GMP Utilities, Equipment, Systems and Software.
Knowledge of recent regulations (ICH, ASTM, FDA, ISPE) and modern CQV practices.
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.
Proficiency with Microsoft Office applications (Word, Excel, Project, PowerPoint, etc.).

All interviews are conducted either in person or virtually, with video required.

About Us

PS, a Berkshire Hathaway Company, is a global leader in developing innovative business solutions for the biotechnology and pharmaceutical industries. Through operational expertise and industry-leading knowledge, skill, and passion, IPS provides consultancy services, architecture, engineering, project controls, construction management, and compliance services that allow clients to develop and manufacture life-impacting products. Its newest acquisition, Linesight, specializes in cost, schedule, risk, program, and project management services in various market sectors, including data centers, life sciences, and high-tech industries. With the addition of Linesight, IPS has over 3,000 professionals in over 45 offices across 17 countries in the Americas, Europe, Asia Pacific, Southeast Asia, Australia, and the Middle East.

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.

Attention Search Firms / Third-Party Recruiters: IPS is not seeking assistance or accepting unsolicited resumes from search firms for employment opportunities with IPS. Regardless of past practice, all resumes submitted by search firms to any employee at IPS via email, the Internet, or directly to hiring managers at IPS in any form without a valid written search agreement in place for a specific position will be deemed the sole property of IPS, and no fee will be paid in the event a candidate is hired by IPS as a result of the referral or through other means.

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