Full-Time

Project – Cqv

Posted on 4/12/2024

CAI

1,001-5,000 employees

Engineering and consulting for critical manufacturing facilities

Consulting

Mid, Senior

London, UK

Requirements

BS or MS in a relevant science or engineering field, or equivalent
5+ years in CQV SME roles for life sciences
Excellent oral and written communication skills
Excellent problem-solving skills
Customer-service focused
Proficient in life science manufacturing processes
Able to travel domestically and internationally if required

Responsibilities

Perform Commissioning, Qualification, Validation team activities with a direct regard for Safety
Generating C&Q Procedures for projects
CQV review/qualify equipment design
Writes, reviews and revises a variety of Installation, Operation and Performance qualification/verification related documents
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
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

About CAI:

CAI is a 100% employee-owned company established in 1996, that has grown year over year to nearly 850+ 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.

Meeting a Higher Standard:

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 Project (CQV) Engineers to join our growing operations in the UK. We are currently targeting Project (CQV) Engineers for roles in the London region. The role of a Project (CQV) Engineer in CAI is to:

·Perform Commissioning, Qualification, Validation team activities with a direct regard for Safety.

·Generating C&Q Procedures for projects.

·CQV review/qualify equipment design – filling line (IMA / Optima)

·Writes, reviews and revises a variety of Installation, Operation and Performance qualification/verification related documents, including any of all of the following: SOPs, validation/verification master plans, guidelines and execution plans

·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.

·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

·5+ years in CQV SME roles for life sciences – prior filling line (IMA / Optima) experience is desirable

·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.

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.

CAI

View

Website

View Company Profile

CAI offers a compelling work environment for professionals in engineering and consulting, particularly in the fields of pharmaceuticals, medical devices, and energy-efficient facilities. Their focus on enhancing operational readiness, managing risks, and improving productivity in quality-critical and mission-critical infrastructure ensures that employees are constantly engaged in meaningful and impactful work. This emphasis on critical industries also positions CAI as a leader in sectors that prioritize precision and innovation.

Company Stage

Pre-seed

Total Funding

$3.4M

Headquarters

Indianapolis, Indiana

Founded

1996

Growth & Insights

Headcount

6 month growth

↑ 2%

1 year growth

↑ 20%

2 year growth

↑ 18%

Benefits

100% Employee Owned

24 Days PTO/5 Sick days per year + Additional Holidays depending on Country

Medical / Dental / Vision (In accordance with each countries’ applicable regulations)

Professional Development (Approximately $5,000 paid career-related, continuing education)

ESOP/401k – 15% Company Contribution

Company Paid Long-Term Disability

Company Paid Life Insurance

Company Paid Parental Leave (In accordance with each countries’ applicable regulations)

Other Benefits Depending on Country