CAI

Operational readiness consulting for pharma

CQV/Validation Engineer

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeIrelandNo salary listed

About the Job

Requirements

A Bachelor of Science or Master of Science degree in a relevant science or engineering field, or equivalent experience.
At least 3 years in CQV subject matter expert roles for life sciences; clean utilities and filling experience is preferable.
Proficient in life science manufacturing processes such as biotechnology, aseptic fill/finish, oral solid dose, or gene therapy, or equivalent experience.
Able to travel domestically and internationally if required.
Strong oral and written communication skills.
Strong problem-solving skills.
Customer-service focus.

Responsibilities

Conduct and lead commissioning, qualification, and validation team activities with direct regard for safety.
Manage the commissioning and qualification documentation and execution lifecycle from SLIA generation through operational qualification completion.
Generate commissioning and qualification procedures for projects.
Approve TOPs.
Facilitate scoping and planning of commissioning spares and consumables.
Deliver and track commissioning and qualification activities as required to meet project schedules.
Prepare Qualification Summary Reports and manage the Requirement Traceability Matrix.
Execute design reviews, shakedown, commissioning, factory acceptance tests, installation qualification, operational qualification, and performance qualification activities.
Manage commissioning and qualification verification activities as requested, including change controls, contractors and vendors, document control, and punch-list management.
Coordinate with project contractors and equipment vendors to execute required tests.
Allocate project resources for efficient execution of project deliverables.
Coordinate support during commissioning and qualification execution.

Desired Qualifications

Clean utilities and filling experience.

About CAI:

CAI is a 100% employee-owned company established in 1996, that has grown year over year to nearly 700 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.

Are you Ready?

Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.

As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:

·We act with integrity,

·We serve each other,

·We serve society,

·We work for our future.

With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.

CAI agents will be exposed to cutting edge technologies in the advanced medicine space. You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to market. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.

Requirements include:

We are now seeking a CQV Engineer to join our growing operations in Ireland The role of a CQV Engineer in CAI is to:

·Conduct and lead Commissioning, Qualification, Validation team activities with a direct regard for Safety.

·Managing the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion.

·Generating C&Q Procedures for projects.

·Approval of TOPs.

·Facilitate scoping / planning of commissioning spares and consumables.

·Deliver the C&Q activities as required to meet the schedule

·Track progress of C&Q activities as required.

·Preparation of Qualification Summary Reports (QSR), and management of Requirement Traceability Matrix (RTM)

·Execution of Design reviews, shakedown, commissioning, FAT's, IQ, OQ, PQ activities.

·Management of any aspect of C & Q, verification as requested i.e., Change Controls, Management of Contractors and Vendors, document control, punch list management.

·Coordinate with project contractors and equipment vendors to execute required tests.

·Allocate project resources for efficient execution of project deliverables.

·Coordinate support during C&Q execution -

Position Requirements:

·BS or MS in a relevant science or engineering field, or equivalent

·3+ years in CQV SME roles for life sciences – Clean Utilities/Filling experience preferable

·Excellent oral and written communication skills

·Excellent problem-solving skills

·Customer-service focused.

·Proficient in life science manufacturing processes in areas such as biotech, aseptic fill/finish, OSD, Gene Therapy or equivalent experience.

·Able to travel domestically and internationally if required.

#LI-JD1

We are an equal opportunity employer; we are proud to employ veterans and promote a diverse culture in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all – our employees, our customers, and the broader society. This job description is not all inclusive and you may be asked to do other duties.

About the Company

CAI

Operational readiness consulting for pharma

CAI Technical Consulting Malaysia SDN (brand cagents.com) provides operational readiness consulting for pharmaceutical, biotech, and healthcare firms. It helps clients prepare for full-scale production through quick operational readiness assessments, gap-tailored plans, and hands-on implementation support in areas like project planning, production operations, asset management, reliability, and sustainability, plus Digital Pathology Validation for Leica Biosystems to meet regulatory standards. The firm differentiates itself by combining rapid assessments with practical, cost-effective strategies, ongoing industry collaboration, and global delivery that informs tailored solutions. Its goal is to help clients accelerate their path to compliant, scalable operations and successful production scale-up.

Company size: 1,001-5,000
Company stage: Pre-seed
Total funding: $3.4M
Headquarters: Indianapolis, IN
Founded: 1996

Recently Posted Jobs

Explore more opportunities at CAI

See more jobs