COMMISSIONING,

QUALIFICATION,
VALIDATION (CQV)

PARTNERING WITH CLIENTS TO PROVIDE GLOBAL INTEGRATED SOLUTIONS

Offices Worldwide
www.jacobs.com
Commissioning, Qualification, Validation (CQV)

I N T E G R AT E D S O L U T I O N S
As the largest provider of professional services in the biopharmaceutical industry, clients benefit from both our local
presence and global reach. Jacobs offers a range of services from advanced planning and programming to design,
construction and commissioning to startup, qualification and validation. This allows us to help our clients throughout the
life cycle of a project.

Our team takes advantage of a unified approach that uses dedicated CQV resources and engages automation, process
and construction engineers to provide clients with comprehensive end-to-end project solutions.

By implementing an integrated project delivery strategy, based on collaboration between design, construction and CQV,
we are able to deliver best-in-class facilities as efficiently as possible. We identify and resolve issues early to avoid
expensive rework and use standard processes to improve our effectiveness.

The result - we design, build, commission, qualify, and validate facilities right the first time bringing clients’ products to
market more quickly; this results in patients receiving the medicines they need and a faster return on your investment.

PROJECT EXAMPLES

Vaccine Bulk Facility Multiple Projects APS Pressurization and cGMP mAb Fill/Pack
Services: EPCM+CQV Services: CQV Services: EP+CQV
Upgrades
Services: CQV
We provided EPCM+CQV We partnered with a major We are providing all CQV
services, achieving an pharmaceutical client across We provided full verification services for a greenfield
unprecedented 24-month the globe to provide CQV services including project biologics manufacturing facility
schedule from charter to services. Projects include: management, protocol in Northern Europe designed to
operational qualification for this „„ Cleaning validation, Malaysia development & execution, and provide production capability
$315 million, 214,000-square- change management support for a range of large-molecule,
„„ Critical component
foot, vaccine manufacturing for an aseptic facility upgrade protein therapeutic products.
assessment, United Kingdom
facility. One third of craft hours project. Project scope included Project scope includes
were moved off site which
„„ cGMP & impact assessment, modifications to the facility, URs, DQ, FAT, SAT, Startup,
allowed modular construction China depyrogenation tunnel, and Commissioning, IQ, and OQ for
to take place while the facility „„ cGMP Review and GAP clean utilities, as well as new syringe & vial filling, formulation,
layout was still being developed Analysis, South Africa Grade B & D air handling units. inspection, labeling, and
(interstitial, AHU, duct risers, „„ Facility risk assessment, All work was required to be packaging processes.
clean room panels). Using this Philippines completed during an eight-
hybrid approach, we completed „„ Full lifecycle C&Q services, week shutdown.
the project 40 percent faster Ireland & UK
than industry benchmarks.
A R E A S O F S P E C I A LT Y
Our experience, expertise, and commitment provides superior services to meet your validation and compliance needs.

CORE CQV SERVICES SUPPORT SERVICES CONSULTING SERVICES

„„ CQV Master Planning „„ SOP Development „„ Site Master Planning

„„ Requirements Development „„ Personnel Training „„ Project Management
„„ Risk Assessments „„ Maintenance & Reliability „„ Compliance Gap Analysis
„„ Design Review and Qualification „„ CAPA & Change Management „„ Quality System Auditing
„„ Factory & Site Acceptance Testing „„ Environmental Monitoring „„ Mock Inspections
„„ Startup & Commissioning „„ Temperature Mapping „„ Design Consultation
„„ Qualification „„ Calibrations and Loop Checks „„ Product Life Cycle Management
„„ Cleaning & Sterilization Validation „„ Serialization „„ Aseptic Processing
„„ Process Validation „„ Computer System Validation „„ Tech Transfer

WHY JACOBS?
„„ We employ self-motivated, high-caliber CQV resources.

„„ We are the largest provider of integrated engineering, procurement, construction management and validation services
and understand the importance of front-end loading CQV activities.

„„ We use design, automation and construction resources to support and optimize commissioning and qualification.

„„ We are an established Life Sciences market leader that has experience with emerging technologies such as gene
therapy, cell therapy, nanotechnology and single use manufacturing.

„„ We leverage our large network of available SMEs to deliver value to our clients.

„„ We get client’s products to market faster with right-sized, scalable project delivery strategies.

„„ We partner with clients to focus on people, performance, safety and integrity - our core values and the foundation of
our Company.

„„ We minimize costs by using local resources in strategic locations around the world.

„„ We can accommodate any science and risk-based life cycle approach whether it is ASTM E2500, BG5 or GAMP 5.

„„ We use standard processes and data management tools to provide compliant and predictable turnkey solutions that
streamline project delivery.
Proven Leadership

Our team brings in-depth knowledge and expertise in CQV and related services. With proficient leaders around
the globe, we understand international and local regulations and are able to use our knowledge and experience
to deliver:

„„ Cost-effective, compliant solutions

„„ Products to market faster
„„ Reliable facilities that support sustainable operations and
process improvements

SCOTT HAMM D AV I D T Y R R E L L DR. ARCHA VERMANI S T E FA N O G E N E S I O

Director of CQV and Compliance Dir. of CQV and Compliance Manager of CQV Director of CQV and Compliance
Services, US Services, Ireland, UK & Scandinavia and Compliance Services, India Services, Mainland Europe

Mr. Scott Hamm has nearly 30 Mr. David Tyrrell has more than Dr. Archa Vermani has more Mr. Stefano Genesio has nearly
years of engineering and project 25 years of engineering and than 15 years of experience 15 years of experience in
management experience in a project management experience designing and qualifying facilities automation engineering and
regulated environment. He has across many industries. He has in accordance with cGMP CQV project management. He
a diverse CQV background and a proven track record building requirements. She is responsible has extensive experience with
experience developing quality teams and delivering projects. for CQV and Regulatory Regulatory Compliance and CQV
system documentation and Mr. Tyrrell has a broad range compliance for India projects activities for the full project life
processes for pharmaceutical, of CQV experience and has and she plays a key role in cycle within the Life Sciences
biotech and medical device managed CQV teams through upfront project planning. Industry.
manufacturers. the entire project life cycle;
from conception to sustaining Dr. Vermani has successfully Utilizing his technical knowledge
Mr. Hamm has served as a manufacturing operations. delivered many National and and management skills, Mr.
member of the ISPE Steering International CQV projects Genesio can quickly identify
Team for the C&Q Community of With over 20 years’ client side from conceptual design clients’ needs and key
Practice and has been involved experience Mr. Tyrrell has a through validation. She has project milestones, in order to
in the review and development clear understanding of customer experience with Sterile, OSD, successfully implement right –
of ISPE guidance documents needs and strives to partner with API, Biotech / Vaccines, Blood sized project delivery strategies.
based on the E2500 science and clients as a solution provider. Plasma Fractionation and FMC
risk-based standard. manufacturing processes.

FOR FURTHER INFORMATION CONTACT:

SCOTT HAMM DAVID TYRRELL DR. ARCHA VERMANI STEFANO GENESIO
Phone: +1.317.850.8797 Phone: +353 (0)1 2027787 Phone: +91 124 3372527 Phone: +39 335 7158051
[email protected] [email protected] [email protected] [email protected]