Job Title:          Scientist

Summary:

This position supports the parenteral pharmaceutical manufacturing facility through the qualification and/or validation of equipment, raw materials, and manufacturing processes. Validation activities include research, protocol writing/execution and final report generation. Additionally, investigations of manufacturing challenges are

conducted, and process improvements are evaluated/ implemented. Final documents are archived and may be included in or support A/NDA submissions, and made available as needed during FDA, MHRA, and client/customer compliance audits.

Essential Duties and Responsibilities:  

Applies knowledge or quickly learns cGXPs, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate. Performs a variety of projects/studies in areas that may include Product/Process, Sterilization, Cleaning and Equipment Validation, as well as projects/studies to support Manufacturing Operations. 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. Serves as project lead with projects of intermediate scope and cross-functional teams. Mentors and provides leadership to junior team members.

 

Qualifications            

Ability to communicate effectively at all levels in verbal and written form. Direct or indirect industry knowledge and the ability to learn new technical information and concepts. Ability to work independently or in teams. Ability to walk some distance 1-3 miles, stand for 3-6 hours and periodically lift 10 - 40 lbs. during the course of a work day as required. Ability to work any shift (1st, 2nd, or 3rd) and any day of the week (7 days) as duties require.

 

Education and/or Experience        

BS preferably in the Sciences/Engineering/Math (other degrees accepted provided the individual has relevant experience -- e.g. education or employment in sciences or validations) having a minimum of 3+ years related experience or 2+ years related experience w/ an advanced degree or demonstrated performance within a technical department within the organization.