Validation Engineer - Katalyst Healthcares & Life Sciences
Dayton, NJ 08810
About the Job
Responsibilities :
- Taking lead role on new equipment validation. Writes protocols, reports (GTRs), Site and Master Batch Record Change Controls and Executes protocols that involves coordination with many functional areas including Production, Planning, Testing Laboratories, etc.
- Applies cGXPs knowledge, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate.
- Performs a variety of projects/studies in areas that include Equipment Validation, as well as projects/studies to support Manufacturing Operations.
- Serves as project lead with projects of extended scope and cross-functional teams.
- Work closely with facilities engineering for equipment implementation, installation, and commissioning.
- Mentors and provides leadership to junior team members.
- Participate in investigations related to process deviations, non-conformances, and CAPAs, and implement corrective and preventive actions as needed.
- Perform T /Rh mapping and create a report for product storage area.
- Providing training and guidance to manufacturing personnel on validation procedures, best practices, and regulatory requirements to ensure understanding and compliance.
- Stay current with industry trends, regulatory requirements, and best practices related to process validation and contribute to the continuous improvement of validation processes and procedures.
- Investigating and resolving issues related to process deviations, equipment malfunctions, and other validation-related problems to minimize disruptions to manufacturing operations.
- 3+ years Pharmaceutical Industry background.
- Veeva Vault Experience.
- GMP, GDP Experience.
- Client (Building Management System).
- The ideal candidate will have experience working in the Pharmaceutical industry and therefore can effectively communicate with all stakeholders involved in this implementation.
- If you have a background with injectables, that is a cherry-on top, however, not a requirement.
Source : Katalyst Healthcares & Life Sciences
