Scientist

Job Title: Scientist

Summary:

• This position supports the parenteral pharmaceutical manufacturing facility through the Cleaning Confirmation / Validation of manufacturing equipment, facility 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 cGMP, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate.
• Performs a variety of projects/studies in areas that may include Cleaning Confirmation, 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.
• Good technical writing skills to write Change Controls, CAPAs, Investigations, Deviations, Protocols and reports related to cleaning validation program.

Qualifications

• Ability to communicate effectively at all levels in verbal and written form.
• Direct or indirect industry knowledge of cleaning validation, DEHT, CEHT, Campaign length, Bracketing strategy, Rinse/Swabbing Techniques .
• 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.

Location:

Cherry Hill, NJ, US, 0800
3

Location:

Cherry Hill, NJ, US, 08003

Nearest Major Market: Philadelphia