Validation Engineer 2
Company: Charles River Laboratories
Posted on: June 25, 2022
For 70 years, Charles River employees have worked together to
assist in the discovery, development and safe manufacture of new
drug therapies. When you join our family, you will have a
significant impact on the health and well-being of people across
the globe. Whether your background is in life sciences, finance,
IT, sales or another area, your skills will play an important role
in the work we perform. In return, we'll help you build a career
that you can feel passionate about.
IMPORTANT: In order to be considered for this position, a resume/CV
must be uploaded and submitted during the application process.
Please make sure work history and education are added correctly.Job
We are seeking a Validation Engineer 2 for our Cell Therapy
Manufacturing Facility located Memphis, TN.
The Validation Engineer 2 will be the functional lead responsible
for development and execution of utilities, systems, and equipment
(FUSE) Validation (CQV) for our cGMP Cell Therapy Manufacturing
Facility located in Memphis, TN. As a technical resource for GMP
regulated facilities, the Validation Engineer 2 will have the
opportunity to work on deliverables for BMS, clean utilities,
cleanroom suites, Cell and Gene Therapy manufacturing equipment and
systems, and complex QC instruments. You will also be responsible
for development and execution of CQV deliverables through formal
assessment, protocol development, testing, and reporting; providing
a high degree of assurance ensuring that critical GxP systems meet
design criteria and user specifications. The Validation Engineer 2
is expected to ensure adequate measures are in place to achieve and
maintain GxP compliance through all Validation lifecycle stages
from inception to retirement.
The following are responsibilities related to the Validation
- Lead efforts to generate documentation which meets regulatory
and industry standard guidelines in a timely and efficient manner
in a challenging and fast-moving environment. These documents
include but are not limited to; User Requirement Specifications,
Functional Specifications, Validation Plans, design / configuration
specifications, traceability matrix, design qualification, IOPQ
protocols and summary reports, supplier assessments, risk
assessments, 21 CFR Part 11 assessments, and overall critical GxP
- Manage implementation of critical systems and equipment that
may also incorporate computerized systems.
- Advanced understanding of the authoring of protocols,
Validation Summary Reports and associated documents.
- Efficient in Microsoft - Office and other software as
- Advanced understanding and experience with regulations and
guidelines such as FDA, EU, ISPE, ISO, NSF, 21 CFR Part 11, and
- Advanced understanding of the Quality Management System, Change
Control, and CAPA
- Be flexible, proficient in technical writing, strong
interpersonal and communication skills.
- Awareness of OSHA and safety programs.
- May be required to work off-shift or weekends to support
- Able to work well in a team-oriented environment.
- Demonstrated relationship, team building skills and able to
encounter challenges.Job QualificationsThe following are the
minimum qualifications related to the Validation Engineer 2
- Bachelor of Science degree in Electrical, Mechanical, Chemical
Engineering or Equivalent Validation Engineer work experience may
be considered, in lieu of a degree.
- Minimum of 3 years of CQV experience in a GxP cleanroom
environment working with critical systems and equipment.
- Experience with process performance qualification (PV/PQ/PPQ)
preferred.IMPORTANT: A resume is required to be considered for this
position. If you have not uploaded your resume in your candidate
profile, please return to upload field and attach your
Charles River is a U.S. Federal Contractor. As a result, we must
follow the Presidential Executive Order to mandate vaccinations,
and ensure our employees are fully vaccinated against COVID-19. Our
main priority is the wellbeing, health, and safety of our people.
We require proof of vaccination from all employees.
Anyone with requests for disability-related and/or religious
exemptions should contact Talent Acquisition
(crrecruitment_US@crl.com) so that information can be provided
about the accommodation process at Charles River.
About Biologics Testing Solutions
With more than 50 years of experience and proven regulatory
expertise, the Charles River Biologics group can address
challenging projects for biotechnology and pharmaceutical companies
worldwide. Offering a variety of services such as contamination and
impurity testing, protein characterization, bioassays, viral
clearance studies and stability and lot release programs, we
support clients throughout the biologic development cycle, from the
establishment and characterization of cell banks through
preclinical and clinical studies to marketed products. Whether
clients need stand-alone services, a unique package of testing, or
insourced support, our Biologics group can create a custom solution
to suit their needs. Each year more than 20,000 biologic testing
reports are sent each and over 200 licenses products are supported
by our biologics testing solutions team.
Keywords: Charles River Laboratories, Memphis , Validation Engineer 2, Engineering , Memphis, Tennessee
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