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 largerprojects, performance of risk assessment of validation requirements, compilation ofvalidation protocols and reports, collation and analysis of process validation data, andwitnessing of certain validation activitiesWork with System and Equipment Owners on validation documentation creation anddevelopment including Regulatory Assessments, Validation Plans, Risk Assessments,Requirements/Design/Functional Specifications, Installation Qualification, OperationalQualification and Performance Qualification Protocols, Reports, and Standard OperatingProceduresPerform computer software Validation/Qualification activities includingdeveloping/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 releasesManage vendor software validation documentationProvide technical expertise, interpretation and direction to management and userdepartments to assure compliance with regulatory requirements, company policies andstandardsReview existing Computerized System Validation (CSV) reports and identify anyRegulatory gaps and provide and execute remediation plans for any identified gapsEnsure the computer software validation program meets applicable regulatoryrequirementsMaintain awareness of activities by routine direct observation of testing laboratories andfrequent interaction with operations staff to provide perspective on routine operations andsupport systemsParticipate as needed to support internal audits, client audits, supplier audits, regulatoryinspections as a Subject Matter Expert for Software ValidationStay current with changes to CSV industry standards, including FDA and EU and otherregulatory bodies, as well as guidance documentsWrite or revise Standard Operating Procedures as requiredPerform other duties as requiredRequirements and Expectations:
BS or MS degree in information technology or related discipline, or equivalentexperienceFive years extensive hands-on software validation experience in the biotechnology orpharmaceutical industries including writing, executing, and summarizing validationprotocols and testing proceduresBroad and in-depth knowledge of computerized systems and regulatory requirements,and current validation approaches to evaluate computerized systemsExperience working in a GxP Life Sciences environment for Computer SystemsValidation (CSV)Strong knowledge of global regulatory requirements for validation, including currentGAMP, ICH guidelines and USP, 21CFR11 and 21CFR58Excellent technical writing skills with strong attention to detailExceptional written and verbal communication skillsAbility to plan, schedule and execute Validation Lifecycle deliverablesAbility to anticipate problems/issues and create contingency plansAbility 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 largerprojects, performance of risk assessment of validation requirements, compilation ofvalidation protocols and reports, collation and analysis of process validation data, andwitnessing of certain validation activitiesWork with System and Equipment Owners on validation documentation creation anddevelopment including Regulatory Assessments, Validation Plans, Risk Assessments,Requirements/Design/Functional Specifications, Installation Qualification, OperationalQualification and Performance Qualification Protocols, Reports, and Standard OperatingProceduresPerform computer software Validation/Qualification activities includingdeveloping/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 releasesManage vendor software validation documentationProvide technical expertise, interpretation and direction to management and userdepartments to assure compliance with regulatory requirements, company policies andstandardsReview existing Computerized System Validation (CSV) reports and identify anyRegulatory gaps and provide and execute remediation plans for any identified gapsEnsure the computer software validation program meets applicable regulatoryrequirementsMaintain awareness of activities by routine direct observation of testing laboratories andfrequent interaction with operations staff to provide perspective on routine operations andsupport systemsParticipate as needed to support internal audits, client audits, supplier audits, regulatoryinspections as a Subject Matter Expert for Software ValidationStay current with changes to CSV industry standards, including FDA and EU and otherregulatory bodies, as well as guidance documentsWrite or revise Standard Operating Procedures as requiredPerform other duties as requiredRequirements and Expectations:
BS or MS degree in information technology or related discipline, or equivalentexperienceFive years extensive hands-on software validation experience in the biotechnology orpharmaceutical industries including writing, executing, and summarizing validationprotocols and testing proceduresBroad and in-depth knowledge of computerized systems and regulatory requirements,and current validation approaches to evaluate computerized systemsExperience working in a GxP Life Sciences environment for Computer SystemsValidation (CSV)Strong knowledge of global regulatory requirements for validation, including currentGAMP, ICH guidelines and USP, 21CFR11 and 21CFR58Excellent technical writing skills with strong attention to detailExceptional written and verbal communication skillsAbility to plan, schedule and execute Validation Lifecycle deliverablesAbility to anticipate problems/issues and create contingency plansAbility to interact effectively with all levels of personnel within the organization
#LI-RA1