Jacobs launch CQV

1. INTEGRATED SOLUTIONS
PARTNERING WITH CLIENTS TO PROVIDE GLOBAL INTEGRATED SOLUTIONS
Commissioning, Qualification, Validation (CQV)
www.jacobs.com
Offices Worldwide

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

3. AREAS OF SPECIALTY
Our experience, expertise, and commitment provides superior services to meet your validation and compliance needs.
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.
CORE CQV SERVICES SUPPORT SERVICES CONSULTING SERVICES
„„ CQV Master Planning
„„ Requirements Development
„„ Risk Assessments
„„ Design Review and Qualification
„„ Factory & Site Acceptance Testing
„„ Startup & Commissioning
„„ Qualification
„„ Cleaning & Sterilization Validation
„„ Process Validation
„„ SOP Development
„„ Personnel Training
„„ Maintenance & Reliability
„„ CAPA & Change Management
„„ Environmental Monitoring
„„ Temperature Mapping
„„ Calibrations and Loop Checks
„„ Serialization
„„ Computer System Validation
„„ Site Master Planning
„„ Project Management
„„ Compliance Gap Analysis
„„ Quality System Auditing
„„ Mock Inspections
„„ Design Consultation
„„ Product Life Cycle Management
„„ Aseptic Processing
„„ Tech Transfer

4. 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
Mr. Scott Hamm has nearly 30 years of
engineering and management experience
in a regulated environment. He has a
strong C&Q background and experience
developing quality system documentation
(e.g., standards, policies, procedures) and
processes for pharmaceutical, biotech and
medical device manufacturers.
Mr. Hamm has served as a member
of the ISPE Steering Committee for
the Commissioning and Qualification
Community of Practice. He was a reviewer
of the ASTM E2500 Standard, as well as the
ISPE Guideline: Science and Risk-based
Approach for the Delivery of Facilities,
Systems, and Equipment. He was an author
of the ISPE Good Practice Guide: Applied
Risk Management for Commissioning and
Qualification, 2011.
Dr. Archa Vermani has more than 15
years of diversified experience in the
field of designing and complying facility
as per cGMP requirements which also
includes planning and executing CQV
activities. She is responsible for CQV and
Regulatory compliance for India projects
and plays a key role in project setup.
Dr. Vermani has successfully delivered
many National and International CQV
projects with different formulations like
Sterile, OSD, API, Biotech/Vaccines,
Blood Plasma Fractionation and FMCG.
Mr. David Tyrrell has more than 25 years
in engineering and project management
across diverse industries and has a
proven track record in building teams
and delivering projects. He is responsible
for CQV and Regulatory compliance for
Ireland, UK & European support.
Mr. Tyrrell has a broad range of CQV
experience and has Managed CQV teams
through project life cycle from concept,
building process systems, resourcing,
team building, start-up, Commissioning,
Qualification, Validation through to
sustaining.
With over 20 years Client side experience,
Mr. Tyrrell has a clear understanding of
customer needs and strives to partner with
Clients as a solution provider.
FOR FURTHER INFORMATION CONTACT:
DAVID TYRRELL
Phone: +353 (0)1 2027787
David.Tyrrell@jacobs.com
DR. ARCHA VERMANI
Phone: +91 124 3372527
Archa.Vermani@jacobs.com
SCOTT HAMM
Phone: +1.317.850.8797
Scott.Hamm@jacobs.com
SCOTT HAMM
US Director of CQV
and Compliance Services
DAVID TYRRELL
Ireland & UK Director of CQV
and Compliance Services
DR. ARCHA VERMANI
India Manager of CQV
and Compliance Services