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Validation Lead

3 months ago

Santa Monica, California, United States Cognizant Full time

Validation Lead

Cognizant Technology Solutions in LSMG is seeking for a Validation Lead who could join our team of Engineering professionals in a permanent role. Our strength is built on our ability to work together. Our diverse set of backgrounds offer different perspectives and new ways of thinking. It encourages lively discussions, inspires thought leadership, and helps us build better solutions for our people and clients. We are looking for someone who thrives in this setting and is inspired to craft meaningful solutions through true collaboration. If you are excited by change, and excel through autonomy, we would love to hear from you

Job Location: El Segundo, CA

Roles & Responsibilities:

Developing validation documentation for pharmaceutical equipment, facilities and computerized systems used in GLP, GMP and GCP environments.
Project Deliverables will encompass validation plans, specifications, test protocols and standard operation procedures and systems may include Process Automation, Laboratory Automation, Enterprise IT Applications and Network Infrastructure.
CSV, GAMP 5 CPFR Part 11, Validation, Worked in V model, SOP & SDLC Lifecycle
To provide a planned approach for the implementation of the CSV deliverables, migration due diligence, GXP and Non GXP areas
Provide guidance and leadership regarding Regulatory Compliance and Quality Management requirements.
Prepare and execute SCA, URS, MVP, VP, RTM, TP, IQ, OQ, PQ, VSR, Traceability Matrix, FRA / FEMA
Exposure to Regulatory Audits
The service will benefit if knowledgeable about and capable of advising on product & ingredient regulation within the industry (not mandatory).
Using previous use cases and best practice counsel on highly regulated environments
Ensure the CSV artefacts are in line and meets regulatory requirements
Preferred Experience in Agile Development
Knowledge on working in Jira / Service Now

Required Qualifications:

Experience/ exposure to Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.
Experience of CSV Validation in Lab systems (LIMS, CDS, SDMS etc) and any diagnostic software like QPCR, QxMGR is added advantage
Should worked in pharmaceutical domain and its related knowledge is must
Good communication and technical writing skills are a must

The annual salary for this position is depending on experience and other qualifications of the successful candidate.

Benefits: Cognizant offers the following benefits for this position, subject to applicable eligibility requirements:

Medical/Dental/Vision/Life Insurance
Paid holidays plus Paid Time Off
401(k) plan and contributions
Long-term/Short-term Disability
Paid Parental Leave
Employee Stock Purchase Plan

Disclaimer: The salary, other compensation, and benefits information is accurate as of the date of this posting. Cognizant reserves the right to modify this information at any time, subject to applicable law.

About Cognizant

Cognizant (Nasdaq: CTSH) engineers' modern businesses. We help our clients modernize technology, reimagine processes and transform experiences so they can stay ahead in our fast-changing world. Together, we're improving everyday life. See how at or @cognizant.