Manager Validation & Engineering
Company: Charles River Laboratories
Posted on: January 16, 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
The Manager, Engineering & Validation supports site projects and
ongoing validation. Primarily responsible for the design,
authorship, and execution of commissioning, qualification and/or
Duties and Responsibilities
- Manages a variety of complex issues in associated projects,
plans and schedules project implementation. Responsible for
defining scope of work for functional team/contractors.
- Reviews and approves complex design concepts and analysis of
technologies that incorporate own area of expertise as well as
multiple disciplines, as applicable.
- Reviews and analyzes proposals to determine if benefits derived
and possible applications justify expenditures. Responsible for
preparation of project cost estimates. Monitors all project
expenditures and cost tracking.
- Provides leadership to assess and provide guidance and risk
assessments regarding validation and compliance requirements in own
area of expertise.
- Assist and guides the strategy and requirements of how
validation is to be accomplished.
- Approves protocols and support documentation.
- Prepares regulatory submissions and presents validation
dossiers to regulatory authorities during routine internal and
- Supports development of best demonstrated validation practices
within the validation department, based on current industry
practices and guidelines.
- Leads projects with complex features.
- Other responsibilities as needed.
Qualifications for the Job
- Bachelor's degree in science, engineering, or another related
- A minimum of 3 years of relevant experience in a GMP regulated
- At least 3 years of commissioning, qualification, and
validation (CQV) required.
- At least 2 years of professional supervision experience
- At least 2 years of project management experience highly
- Knowledge of Industry guidelines (ISPE, PDA), US and
international regulations (FDA, ICH, ISO, EU) for GMP regulated
- Validation and/or system experience.
- Ability to effectively coordinate contractors.
- Ability to influence outside of immediate scope of
- Direct experience with manufacturing operations and
biotechnology processes required.
- Strong organizational skills, excellent writing, and
- Proficiency with Microsoft Office including Word, Excel, and
PowerPoint. Microsoft Project and Visio a plus.
- Must be self-motivated, capable of analyzing and solving
complex problems through innovative thought and experience.
- Has demonstrated effective leadership and supervisory
skills.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 by
December 8, 2021. Our main priority is the wellbeing, health, and
safety of our people. We will be requiring 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, Rockville , Manager Validation & Engineering, Executive , Rockville, Maryland
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