CSV Lead
Location: King of Prussia
Posted on: June 23, 2025
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Job Description:
We are HCLTech, one of the fastest-growing large tech companies
in the world and home to 219,000 people across 60 countries,
supercharging progress through industry-leading capabilities
centered around Digital, Engineering and Cloud. (www.hcltech.com )
The driving force behind that work, our people, are diverse,
creative, and passionate, raising the bar for excellence on a
regular basis. We, in turn, work hard to bring out the best in them
as we strive to help them find their spark and become the best
version of themselves that they can be. If all this sounds like an
environment you’ll thrive in, then you’re in the right place. We
are looking for a highly talented and self- motivated CSV Lead to
join us on our journey in advancing the technological world through
innovation and creativity. Job Title: CSV Lead Job ID: 2662405
Position Type: Full-time Location: King of Prussia, PA (Hybrid)
Role/Responsibilities Activities Requirement Specifications,
Functional Specifications User Stories / Acceptance Criteria and
ensures completeness of test script with traceability Ensures Risk
Assessment is completed for all the requirements and test cases are
designed in reference to the risk levels identified for the
requirements. Performs review of pre-executed test protocol which
includes all the basic elements of a test script, completeness and
appropriateness of the test case to the requirement Ensures
pre-executed test protocol has the necessary test data requirements
to run the tests Reviews post-executed test protocols for the
completeness, accuracy of the results and evidence and enables team
on the defect management process. Able to author Validation Plan
and compile Validation Summary Report and generates RTM Reviews and
ensures that the Operational Procedure for the application is ready
Is able to handle Change Requirement related implementation for
small changes - responsible for Implementation Plan, Impact
Assessment, Test Plan/ Results, Defects and RTM Prior experience in
using tools like ALM, DMS and JIRA Good to have experience in
implementing US-DSCSA Single point of contact for Geo and
functional specific scope of services related to system assurance
and compliance role including CSA, Val SME and test management.
Responsible for Geo and functional specific service quality,
performance and customer satisfaction, demand management Perform
CSL roles such as CSA, Validation SME, and Test Manager as required
by CSL QMS Build and manage relationship with regional stakeholders
including gathering and resolving feedback Review system assurance
and compliance deliverables and guide team on daily basis
Qualifications & Experience Minimum Requirements Computer System
Validation, Computed system assurance, GAMP, GxP risk assessments,
Change Management Desired Qualifications JIRA Veeva Argus Agile and
Waterfall methodology Pay and Benefits Pay Range Minimum: $65,000
Pay Range Maximum: $122,000 HCLTech is an equal opportunity
employer, committed to providing equal employment opportunities to
all applicants and employees regardless of race, religion, sex,
color, age, national origin, pregnancy, sexual orientation,
physical disability or genetic information, military or veteran
status, or any other protected classification, in accordance with
federal, state, and/or local law. Should any applicant have
concerns about discrimination in the hiring process, they should
provide a detailed report of those concerns to secure@hcltech.com
for investigation. Compensation and Benefits A candidate’s pay
within the range will depend on their work location, skills,
experience, education, and other factors permitted by law. This
role may also be eligible for performance-based bonuses subject to
company policies. In addition, this role is eligible for the
following benefits subject to company policies: medical, dental,
vision, pharmacy, life, accidental death & dismemberment, and
disability insurance; employee assistance program; 401(k)
retirement plan; 10 days of paid time off per year (some positions
are eligible for need-based leave with no designated number of
leave days per year); and 10 paid holidays per year. How You’ll
Grow At HCLTech, we offer continuous opportunities for you to find
your spark and grow with us. We want you to be happy and satisfied
with your role and to really learn what type of work sparks your
brilliance the best. Throughout your time with us, we offer
transparent communication with senior-level employees, learning and
career development programs at every level, and opportunities to
experiment in different roles or even pivot industries. We believe
that you should be in control of your career with unlimited
opportunities to find the role that fits you best.
Keywords: , East Brunswick , CSV Lead, IT / Software / Systems , King of Prussia, New Jersey
