Location: Exton, PA (Must be local or willing to relocate)
Job Type: Full-time
About Us: Prana Life Sciences is a next generation Life Sciences Information Technology, Full Managed Services company that aims to Elevate Life. The company offers modern, comprehensive validation, migration, integration and IT consulting services.
It has expertise in providing Managed Services for a variety of Life Sciences IT technologies such as: Veeva, Medidata, and Salesforce to help reduce regulatory risk and improve operational efficiencies. From bespoke IT services to ready-to-implement IT solutions, Prana Life Sciences has the best of breed custom solution at hand.
Position Overview: We are seeking a GxP Validation Engineer to help validate our life sciences clients’ computer systems. This role is crucial in developing quality management systems and validation artifacts for IT systems in the highly regulated life sciences industry.
Key Responsibilities:
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Develop quality management systems, including policies, manuals, procedures, work instructions, checklists, forms, and quality documentation templates
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Create validation artifacts for IT systems, such as Risk Assessment Reports, System Validation Plan (SVP), User Requirement Specifications (URS), Configuration Specifications (CS), Test Plans (TP), User Acceptance Test (UAT), Test Scripts (TS), Trace Matrix (TM), and Validation Summary Report (VSR)
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Develop IQ/OQ/PQ validation protocols and related documentation
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Ensure compliance with GxP, 21 CFR Part 11, HIPAA, EDQM, ICH, GDPR, ISO, CE, NABH, CMMI, and various other regulatory requirements Required.
Required Qualifications:
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3-5 years of experience performing Computer System Validation for the Life Sciences Industry
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Bachelor’s degree in a related field
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Expertise in developing validation protocols and documentation
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Experience in life sciences, healthcare, and information technology ensuring regulatory compliance
Preferred Qualifications:
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1-2 years of Veeva Vault experience
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Experience in configuration and data migration for Veeva Vault Quality Suite, Clinical Suite, Regulatory (RIM) Suite, PromoMats, MedComms, etc.
Benefits:
- Health Insurance
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401K Plan
How to Apply: Interested candidates should submit their resume and a cover letter outlining their qualifications and interest in the position to [email protected]. Provide specific examples of your past accomplishments in this or similar roles. Please include “Veeva CRM Solution Architect Application” in the subject line.
Equal Opportunity Employer: Prana Life Sciences is an equal opportunity employer and welcomes applicants from all backgrounds to apply.
Join us at Prana Life Sciences and be part of a team that values innovation, integrity, and collaboration. Help us drive our mission to provide exceptional solutions to our clients and take your career to new heights.
