This position is responsible supporting the Validation Department to commission, qualify and decommission pharmaceutical packaging equipment. They will lead, manage, and support a variety of on-going projects for clients in the pharmaceutical industry related to packaging engineering. Position activities include document generation (IQ, OQ, PQ) and execution, change management (deviations and change controls), prepare project schedules, monitoring progress, communicating status, and ensuring successful project completion. Projects are generally associated with client compliance to FDA and Industry standards at various levels.
Responsibilities
Compose and executevalidation protocols for packaging line equipment(IOQ, PQ, Commissioning protocols) as well as decommissioning protocols
Research, develop, design, evaluate, document and manage packaging line equipment, systems, materials, incoming receiving, and distribution systems
Responsible for compliance with applicable Corporate and Divisional Policies and procedures
Handle change control lifecycles and deviation investigations includingroot cause analysis and CAPA activities
Directs support personnel, coordinates, and reports on project activities
Investigates and evaluates existing technologies for potential improvement
Reviews or coordinates vendor activities to support development and use
Independently drive Packaging Engineering Projects for NPI and On-Market
Position skills and requirements:
Bachelor's degree in Engineering field plus 2-5 years of related work experience in pharmaceutical manufacturing
Highly motivated and independent individual
Detail oriented and comfortable working in a fast-paces office environment
Experience with document management systems is preferred
Proficiency in MS Office with expertise in Microsoft Work, PowerPoint and Excel