Required Qualifications:
- Bachelor's degree in Engineering, Life Sciences, Computer Systems, or a related technical discipline.
- 3+ years of validation experience within a regulated pharmaceutical, biotech, medical device, or GMP manufacturing environment.
- Experience authoring and executing validation protocols and reports for DQ/IQ/OQ/PQ/PV activities.
- Working knowledge of GMP regulations, FDA guidance, EU Annex 15, and GAMP 5.
- Experience supporting equipment qualification, facility modifications, or manufacturing process validation.
- Strong technical writing and documentation skills.
- Experience managing validation documentation and project deliverables across multiple projects simultaneously.
Preferred Qualifications:
- Experience supporting aseptic processing, fill-finish, device assembly, packaging, or facility utility systems.
- Experience with Veeva Quality applications and/or HP ALM/eTIMS.
- Experience participating in FAT, SAT, commissioning, and startup activities.
- Knowledge of MES, SCADA, PLC, automation, and computerized system validation concepts.
- Ability to independently drive validation activities with minimal oversight in a fast-paced project environment.
Job Description:
We are seeking a Validation Engineer to support a growing portfolio of capital projects and manufacturing initiatives. This individual will be responsible for planning, authoring, executing, and reporting validation activities across pharmaceutical manufacturing systems, facilities, utilities, equipment, automation platforms, and technology modernization projects. The engineer will work closely with Project Managers, Engineering, Automation, Operations, Quality, and Maintenance teams to ensure projects are delivered in compliance with GMP requirements and internal validation standards. Responsibilities align closely with validation practices supporting equipment qualification, facility modifications, packaging, assembly, filling operations, utilities, and computerized systems.
Key Responsibilities
- Develop, revise, and maintain validation lifecycle documentation in accordance with Novo Nordisk procedures and regulatory requirements.
- Author and execute validation deliverables, including: Validation Plans and Reports, User Requirements Specifications (URS), Functional and Design Specifications, Risk Assessments, Traceability Matrices, Decommissioning Plans and Reports
- Create, execute, and summarize: Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Process Validation (PV)
- Support commissioning and qualification efforts to ensure systems are ready for validation activities.
- Participate in Factory Acceptance Testing (FAT) and support Site Acceptance Testing (SAT) activities as required.
- Track validation-related project documentation and maintain project status updates for assigned initiatives.
- Communicate project risks, issues, and escalations to Project Managers and stakeholders.
- Investigate, document, and support resolution of deviations, discrepancies, and engineering changes identified during validation execution.
- Initiate, author, and support Change Controls while assessing validation impacts associated with proposed modifications.
- Utilize approved electronic quality management systems including: HP ALM / eTIMS, Veeva, QualityDocs
- Veeva Vault Quality
- Collaborate with Engineering, Automation, Operations, Quality Assurance, and Maintenance teams to maintain validated systems throughout the project lifecycle.
- Ensure all deliverables comply with current GMP regulations, FDA requirements, EU Annex 15, GAMP 5 guidance, and Novo Nordisk quality procedures.
- Support project turnover, startup, and sustained validated operation of manufacturing and facility systems.
