Sr. CSV Engineer
Company: Jacobs
Location: Kalamazoo
Posted on: February 21, 2021
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Job Description:
Our People & Places Solutions business - reinforces our drive to
improve the lives of people everywhere and epitomizes the "why" of
what we do - the tremendous positive impact and value our solutions
bring to our communities and society as a whole. From facilities
delivering life-saving therapies and ensuring clean water to
enabling the connection of people through all modes of
transportation and providing access to technology - we're
integrating a multitude of these solution elements to build the
smart environments of tomorrow.Start your Jacobs career with a
company that inspires and empowers you to deliver your best work so
you can evolve, grow and succeed - today and into tomorrow.Your
ImpactHere at Jacobs, we apply our expertise and knowledge as we
look into the future with great optimism and focus. We don't settle
until we give our best and know that we're making a difference.As a
Computer System Validation (CSV) Engineer, you'll join our
collaborative team providing CSV/CQV support to clients that
manufacture GMP products on a consistent basis in conjunction with
industry best practices. We are looking for a passionate CSV
Engineer who is driven by collaboration, exceeding expectations,
and challenging the status quo.You'll be accountable for developing
CSV/CQV planning documents to manage CQV projects, generating and
executing CSV protocols (IQ/OQ/PQ) using Good Documentation
Practices (GDPs), investigating and resolving protocols exceptions
or discrepancies, developing technical reports and CSV summary
reports, and starting up equipment in a safe and effective manner;
as well as performing risk assessments and impact assessments.
You'll also be accountable for developing GxP computer validation
and CFR 21 Part 11 related documentation such as assessments,
plans, URS, FRS, and summary reports.Bring your curiosity, talent
for multi-tasking?and collaboration, and extreme organizational
skills and we'll help you grow, pursue and fulfill what drives you
- so we can make big impacts on the world, together.?Here's What
You'll Need* Bachelor's degree in Electrical or Computer
Engineering or equivalent* At least 8 years of CSV experience in
the Life Sciences industry* Understanding of Good Manufacturing
Practices (GMPs)* Strong technical writing skills* Proficient with
Microsoft Office - Word, Excel, PowerPoint, Project* Flexibility
and willingness to travel and work at various clients'
locationsIdeally, you'll also have* Experience with qualifying
SCADA, Delta V, BAS and BMS systems* Knowledge of US FDA (21 CFR
210, 211, 810) and EU EMEA regulations* Knowledge of industry
guidanceoISPE Baseline Guide 5 Commissioning and QualificationoISPE
GAMP V, A Risk Based Approach to Compliant GMP Computerized
SystemsoASTM E2500 Standard Guide for Specification, Design, and
Verification of Pharmaceutical and Biopharmaceutical Manufacturing
Systems and EquipmentoISPE Guideline Science and Risk-based
Approach for the Delivery of Facilities, Systems, and Equipment,
2011oISPE Good Practice Guide Applied Risk Management for
Commissioning and Qualification, 2011* Six Sigma
Certification#LifeSciences #AFJacobs is an Equal
Opportunity/Affirmative Action Employer. All qualified applicants
will receive consideration for employment without regard to race,
religion, creed, color, national origin, ancestry, sex (including
pregnancy, childbirth, breastfeeding, or medical conditions related
to pregnancy, childbirth, or breastfeeding), age, medical
condition, marital or domestic partner status, sexual orientation,
gender, gender identity, gender expression and transgender status,
mental disability or physical disability, genetic information,
military or veteran status, citizenship, low-income status or any
other status or characteristic protected by applicable law. Learn
more about your rights under Federal EEO laws and supplemental
language.At Jacobs, we're challenging today to reinvent tomorrow by
solving the world's most critical problems for thriving cities,
resilient environments, mission-critical outcomes, operational
advancement, scientific discovery and cutting-edge manufacturing,
turning abstract ideas into realities that transform the world for
good. With $13 billion in revenue and a talent force of more than
55,000, Jacobs provides a full spectrum of professional services
including consulting, technical, scientific and project delivery
for the government and private sector.
Keywords: Jacobs, Kalamazoo , Sr. CSV Engineer, Engineering , Kalamazoo, Michigan
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