Job Summary
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 execute validation 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 including root 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
Compensation and Benefits
* Expected pay range per year: $70,000-$90,000 USD
* Expected benefits include: Medical, Dental, Vision, PTO, 401K