Qualifications:
- Bachelor's degree in Engineering or related field
- 3+ years of validation experience in a cGMP environment, supporting equipment qualification and facilities commissioning activities
- Strong knowledge of validation principles, including IQ/OQ/PQ protocols.
- Experience with Process/Equipment/Computer System Validation
Pluses:
- Master's Degree Engineering or related field
- Experience with computer system validation (CSV) and data integrity principles.
Responsibilities:
A pharmaceutical company in the Clayton, NC area is looking for a Validation Engineer to join their growing team. Areas where projects will be executed are in facility systems, aseptic formulation and filling, device assembly and packaging, IT systems, and QC. It is likely that candidates with expertise in IT systems are assigned to projects in conjunction with a general validation resource.
Responsibilities:
- Generate and/or update all validation related documents according to Novo Nordisk procedures (ie. validation planning, specifications, risk assessments, protocols, reports).
- Generate and execute all documentation for DQ, IQ, OQ, and PV activities.
- Responsible for tracking all project related documentation related to validation including protocols, specifications, and impacted SOPs.
- Generate and act as owner of the change control.
- Utilize NovoGlow and eTIMS software to generate validation documents.
- Lead effort for generating documentation related to decommissioning activities
