Fresenius Medical Care North America Software Quality (Validation) Engineer II in Waltham, Massachusetts

Software Quality (Validation) Engineer II, Fresenius USA Manufacturing, Inc., a Fresenius Medical Care N.A. company, Waltham, Massachusetts

Purposeand Scope:

Responsible for ensuring that Fresenius Medical Care N.A. (FMCNA) regulated computer systems are developed, validated, and maintained in compliance with corporate software validation lifecycle policies and procedures.

Principal Dutiesand Responsibilities:

  • Developingprofessional expertise and applying company policies and procedures torepresent the Quality Systems Department on software development teams as asoftware validation partner.

  • Partneringwith business teams and the IT Department to ensure that computerized qualitysystems are compliant with FMCNA procedures, FDA Quality System Regulations, 21C.F.R. Part 11 and GAMP5.

  • Creatingand/or overseeing the creation of validation deliverables including but notlimited to validation assessments, validation plans, test plans, testprotocols, test reports, validation summary reports, and trace matrices, asneeded to support local and enterprise systems implementation in a regulatedFDA environment. Leading the review and approval of validation deliverables.

  • Executingtest protocols as necessary. Conducting independent reviews of test executions.

  • Assistingbusiness owners/teams and the IT Department in the definition and creation ofbusiness requirements, functional specifications, and system specifications asnecessary.

  • Complyingand maintaining approved project deliverables.

  • Communicatingproject and compliance issues to Quality Systems management.

  • Supportinginternal and external regulatory audits/inspections by presenting and defendingsystem validation projects and documentation during audits and FDA inspectionsas Subject Matter Expert.

  • Providingguidance and direction to external contractors working on system validationprojects.

  • Ensuringthat pertinent validation deliverables are of high product quality and arecomplaint with the FMCNA policies/procedures.

  • Workingwith moderate supervision to fulfill duties in accordance with requirements ofthe QSR regulations, GAMP5 and Corporate policies and procedures.

  • Followingall policies, guidelines and SOPs as required.

  • Workingon problems of moderate scope where analysis of situation or data requires areview of a variety of factors. Exercising judgment within defined proceduresand practices to determine appropriate action.

  • Reviewingand complying with the Code of Business Conduct and all applicable companypolicies and procedures, local, state and federal laws and regulations.

EducationExperience and Required Skills:

This position requires a Master’s degree (or an equivalent foreign degree) in Computer Science, Information Technology, Biomedical Engineering, Pharmaceutics or a related field as well as at least one (1) year of experience as a Pharmaceutical Validation Engineer. Must have experience (which can be gained concurrently with the primary experience requirement above) with: (i) FDA Quality System regulations in relation to computer system validation; (ii) preparing detailed Test Summary and Validation Summary reports based on results of validation and qualification tests of procedures and protocols; and (iii) experience with Windchill and SAP systems.