Software Validation Engineer
Pharmaron

Job Info

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Absorption Systems, a Pharmaron Company, a contract research organization is seeking a candidate for a Software Validation Engineer to support both its Boston, Massachusetts and Germantown, Maryland locations. The Software Validation Engineer maintains all GLP/GMP computer systems in a compliant state. This position actively performs or supports all computerized software and automated equipment validation.

Key Responsibilities:

• Implement and maintain the validation program for computer systems and automated equipment per applicable regulatory guidelines
• Perform computer software Validation/Qualification activities including developing/executing software SDLC (Software Development Life Cycle) documents (URS, Functional Requirements, Risk Assessment Design Specification, IQ, OQ, PQ)
• Work with system and equipment owners and actively manage validation documentation creation and development including GxP Assessments, Validation Plans, Risk Assessments, Requirements/Design/Functional Specifications, Installation Qualification, Operational Qualification and Preventative Qualification Protocols, Reports, and Standard Operating Procedures
• Provide compliance guidance for GxP software updates and releases
• Manage vendor Validation Documentation
• Monitor processes for adherence to established procedures/regulatory compliance
• Provide technical expertise, interpretation and direction to management and user departments to assure compliance with regulatory requirements, company policies and standards
• Review existing Computerized System Validation (CSV) reports and identify any GxP gaps and provide and execute remediation plan for any identified gaps
• Ensure validation program meets applicable regulatory requirements
• Provide guidance for quality related issues and consult with QA Management to resolve complex quality issues
• Responsible for supporting internal and external inspections as a Subject Matter Expert for Software Validation
• Participate as needed to support internal audits, client audits, supplier audits, regulatory inspections
• Stay current with changes to GxP, including FDA and EU and other regulatory bodies, as well as guidance documents
• Write or revise Standard Operating Procedures as required
• Perform other duties as required

Requirements and Expectations:

• BS or MS degree in information technology or related discipline, or equivalent experience
• Extensive hands-on software validation experience in the biotechnology or pharmaceutical industries including writing, executing, and summarizing validation protocols and testing procedures
• Broad and in-depth knowledge of computerized systems and regulatory requirements, and current validation approaches to evaluate computerized systems
• Experience working in a GxP Life Sciences environment for Computer Systems Validation (CSV)
• Strong knowledge of global regulatory requirements for validation, including current GAMP, ICH guidelines and USP, 21CFR11, 21CFR58, 21CFR210 and 21CFR211
• Excellent technical writing skills with strong attention to detail
• Exceptional written and verbal communication skills
• Ability to plan, schedule and execute Validation Lifecycle deliverables
• Ability to anticipate problems/issues and create contingency plans
• Ability to interact effectively with all levels of personnel within the organization
• About 20% travel will most likely be required and some work remotely.

This job has expired.