Jobs

Description

Duties

• Independent drafting and execution of complex validation plans, protocols, and test strategies to ensure compliance and expedited release of critical site equipment.
• Candidate is considered and experienced professional requiring minimal assistance from more experienced colleagues.
• The candidate is balancing their own competing priorities while helping ensure that work generated globally is conducted per regulatory requirements and company procedures.
• Serve on assigned internal and external project teams (change controls, deviations, technology transfer) as a technical/compliance resource to solve quality related issues and/or support continuous improvement.
• Train personnel in quality and validation principals
• Support, Engineering and departments in the selection, review, acquisition, and upgrade of systems and production equipment. 
• Provide technical support in developing user and functional requirements specifications, URS, RA FRS and DQ for systems and equipment.

Routine qualification execution includes:

• Equipment ,facilities, utilities, computer systems qualification for complex biopharmaceutical production equipment.
• Room Qualification and Smoke studies in grade A pharmaceutical facilities
• Comprehensive knowledge and understanding pharma grade utilities ( water HVAC, gases)
• Support Maintenance, Engineering and Production Depts. in the selection, review, acquisition, and upgrade of systems and production equipment.
• Provide technical support in developing user and functional requirements specifications, URS, RA, FRS, and DQ for systems and equipment.
• Develops and assists with audit responses and completion of assigned CAPAs by target due dates.Included is the responsibility for making sure Validation areas are "inspection ready" at all times.
• Execute all actions required to support Change Control, Deviation and CAPA on-time closure

Skills:    

• 6 years GMP validation or similar experience in a GMP manufacturing or similar production environment
• Minimum of 10 years GMP validation experience in a GMP or regulated manufacturing or similar environment in lieu of a degrees.
• Experience must be inclusive of at least 3 years leading projects.
• Excellence in comprehension/application of FDA/EU/USDA regulatory requirements for production and distribution of regulated biological articles

Education:         

• Bachelors , preferably in a science or engineering related field