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Charles River Laboratories
Wayne, PA, United States
For 75 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 ski
Job Source: Charles River LaboratoriesCharles River Laboratories
Wayne
For 75 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 ski
Job Source: Charles River LaboratoriesBayer (Schweiz) AG
, PA, United States
At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabil
Job Source: Bayer (Schweiz) AGClarkston Consulting, Inc.
Philadelphia, PA, United States
Clarkston Consulting is seeking motivated, self-driven leaders who are energized by team results and interested in joining a firm that values its culture and people as its biggest strengths. Come join us as a Computer Systems Validation Consultant, and in this role, you will deliver creative business solutions to our market-leading clients in the l
Job Source: Clarkston Consulting, Inc.Frontage Laboratories
Exton, PA, United States
Team Leader, Computer System Validation and Application Support Title: Team Leader, Computer System Validation and Lab Application Support Location: Exton, PA Reports to : VP, QA and IT compliance Full-time (40 hrs./week) Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization o
Job Source: Frontage LaboratoriesAce American Insurance
Philadelphia, PA, United States
Product Validation Specialist - 8373 DESCRIPTION/RESPONSIBILITIES: In this role, you will work closely with the NA Digital Consumer Team, product owners, Tech Team, and other members of the Operations group in testing, implementing, and managing products, processes, user acceptance testing and data validation to dramatically improve the customer e
Job Source: Ace American InsuranceVanguard
Malvern, PA, United States
Enterprise Model Governance is seeking an experienced model risk professional to join our team. This is an individual contributor role within the Second Line of Defense supporting the model risk management function. You will perform independent validation of machine learning (ML) models used within various lines of business. In this role you be wo
Job Source: VanguardTATA ELXSI
Philadelphia, PA, United States
Job duties as a Computer Systems Architect: Engaging in requirements gathering and technical discussions (15%) Analyzing the requirements and conducting a detailed feasibility study of the same (3%) Understanding the different premium apps that need to be integrated on the platform and understanding their dependencies in detail (7%) Preparing the d
Job Source: TATA ELXSIWayne, PA, United States
Manage computerized system validation activities in CRL Manufacturing Operations, ensuring compliance and quality in equipment and software. Responsible for documentation maintenance and serving as a resource for validation team members, contractors, and vendors.
Responsibilities:
Lead full lifecycle of validation projects, delivering on time and to specification.
Write and review validation deliverables (e.g., Validation Plans, Summary Reports).
Develop and update test validation procedures in compliance with regulatory requirements.
Maintain current Systems Inventory and validation documentation.
Archive validation documentation as per procedures.
Assist in writing SOPs for the Validation Department.
Coordinate installation, maintenance, and repair of computerized systems.
Facilitate project meetings and produce related documentation (e.g., meeting minutes).
Train and support staff on validation projects.
Manage cross-functional teams and provide project updates.
Communicate project expectations clearly and timely to team members and stakeholders.
Assist other departments with validation requirements as needed.
Report Quality Management System non-compliances to Senior Management.
Plan and schedule project timelines and milestones.
Implement solutions to validation issues.
Present validation systems program during audits.
Perform other related duties as assigned.
Job Qualifications:
Education: Bachelor’s degree in computer science, scientific, or related discipline.
Experience: 5-7 years in Computer System Validation; experience in GxP laboratory preferred.
Certification/Licensure: Test or validation certification desired.
Other: Comprehensive knowledge of regulatory requirements (e.g., GxPs, 21 CFR Part 11, Annex 11). Strong organizational and analytical skills, ability to adapt to changing environments.
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Email Alert for Computer Systems Validation Specialist jobs in Wayne, PA, United States
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