Pharmaron
Software Validation Engineer (GXP)
Pharmaron, Exton, Pennsylvania, United States, 19341
We are searching for a Software Validation Engineer to join our team in Exton, PA. 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:
Actively manage and participate in the execution of all stages of the validation life-cycle, including development of project design, generation of validation plans for larger projects, performance of risk assessment of validation requirements, compilation of validation protocols and reports, collation and analysis of process validation data, and witnessing of certain validation activities Work with System and Equipment Owners on validation documentation creation and development including Regulatory Assessments, Validation Plans, Risk Assessments, Requirements/Design/Functional Specifications, Installation Qualification, Operational Qualification and Performance Qualification Protocols, Reports, and Standard Operating Procedures Perform computer software Validation/Qualification activities including developing/executing software SDLC (Software Development Life Cycle) documents (URS, Functional Requirements, Trace Matrix, Risk Assessment, Design Specification, IQ, OQ, PQ) Provide compliance guidance for GLP software updates and releases Manage vendor software validation documentation 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 Regulatory gaps and provide and execute remediation plans for any identified gaps Ensure the computer software validation program meets applicable regulatory requirements Maintain awareness of activities by routine direct observation of testing laboratories and frequent interaction with operations staff to provide perspective on routine operations and support systems Participate as needed to support internal audits, client audits, supplier audits, regulatory inspections as a Subject Matter Expert for Software Validation Stay current with changes to CSV industry standards, 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 Experience working in a GMP Life Sciences environment for Computer Systems Validation (CSV) Strong knowledge of global regulatory requirements for validation, including current GAMP, ICH guidelines and USP, 21CFR11 and 21CFR58 Five years 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 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
#LI-RA1
Key Responsibilities:
Actively manage and participate in the execution of all stages of the validation life-cycle, including development of project design, generation of validation plans for larger projects, performance of risk assessment of validation requirements, compilation of validation protocols and reports, collation and analysis of process validation data, and witnessing of certain validation activities Work with System and Equipment Owners on validation documentation creation and development including Regulatory Assessments, Validation Plans, Risk Assessments, Requirements/Design/Functional Specifications, Installation Qualification, Operational Qualification and Performance Qualification Protocols, Reports, and Standard Operating Procedures Perform computer software Validation/Qualification activities including developing/executing software SDLC (Software Development Life Cycle) documents (URS, Functional Requirements, Trace Matrix, Risk Assessment, Design Specification, IQ, OQ, PQ) Provide compliance guidance for GLP software updates and releases Manage vendor software validation documentation 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 Regulatory gaps and provide and execute remediation plans for any identified gaps Ensure the computer software validation program meets applicable regulatory requirements Maintain awareness of activities by routine direct observation of testing laboratories and frequent interaction with operations staff to provide perspective on routine operations and support systems Participate as needed to support internal audits, client audits, supplier audits, regulatory inspections as a Subject Matter Expert for Software Validation Stay current with changes to CSV industry standards, 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 Experience working in a GMP Life Sciences environment for Computer Systems Validation (CSV) Strong knowledge of global regulatory requirements for validation, including current GAMP, ICH guidelines and USP, 21CFR11 and 21CFR58 Five years 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 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
#LI-RA1