Job Title:          Senior 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 thorough understanding of cGXPs, 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, Clean Room Qualification, as well as projects/studies to support manufacturing. Handles projects that are more complex and broader in scope, such projects require team leadership, task prioritization, and management of budget and/or time constraints.  Must demonstrate competent and effective planning, coordination, and organizational skills. Writes/Reviews IQ/OQ/PQ protocols, reports, Change Controls. Conducts Studies/Executes protocols. Provides mentoring and leadership to less experienced staff.

 

Qualifications            

Ability to communicate effectively at all levels in verbal and written form, including technical/business writing. Proficient in Microsoft Word and Excel, Visio. Proficient in Statistical Analysis. Proficient in HMI/PLC/PC Validation including 21 CFR 11 Testing. Sound industry knowledge, project proficiency, and autonomy expected.  May be considered a Subject Matter Expert (SME) in various disciplines.  Knowledgeable in HVAC operations of Clean Rooms. Familiar with Siemens BMS/EMAS systems or comparable products. Mechanical understanding of Filling, Inspection, and Packaging Equipment for processing of Sterile Pharmaceuticals.  Must be able to identify opportunities for optimization of processes within the department or the plant. Ability to work independently or in teams.   Ability to walk some distance 1-3 miles, stand for 3-6 hours and 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 Engineering/Pharmaceutical Sciences (other degrees accepted provided the individual has relevant equipment validation experience) having a minimum of 5+ years related experience or 4+ years related experience w/ an advanced degree.