Validation Specialists (Validation and Qualification)
PharmEng Technology is currently seeking multiple Validation Specialists
for roles in FL. The positions are available immediately conditional of a successful interview.
- Provide direct execution support for C&V activities.
- Author and execute qualification documents such as Validation Plans, Risk Assessments, Qualification Plans, Installation Qualification Protocols, Installation Qualification Protocols, Operations Qualification Protocols, Qualification Summary Reports, Trace Matrices, URS and Specifications.
- Verification protocols will be written and tested so as to enforce user & equipment safety at all times.
- Verification IOV and PQ testing must be cGMP compliant. The ultimate goal of Verification is to verify end product conformance to regulatory requirements and critical aspects.
- Develop Final Reports of all IOQs and some PQs, including the packages containing all supporting data that are submitted to the library.
- Document all deviations (including Protocol Non-Conformance Reports (PNRs) requiring QA approval).
- Routing documents for review or approval.
- Attend project meetings as required.
- Experience with various building systems and support equipment.
- B.Sc. degree or related professional experience within the Biopharmaceutical Industry.
- 3-10 years previous validation experience required.
- Developmental experience within a specific area of validation or engineering. Knowledge of current validation/engineering technologies and maintain a solid proficiency of computer skills.
- Candidate will be capable of working independently while on assignment, as well interacting with the client in providing responses to project progress and updates on assignment progress.
- Knowledge of validation principles, standard concepts, practices, procedures and requirements in GMP regulated environments.
- Position requires quality and scientific writing skills and capable of working to project timelines.
- Excellent verbal, written and interpersonal communication skills.