Job Summary: 

This role will be responsible for performing activities related to the Computer System Validation process for GAMP5 Category 3/4/5 GxP systems and qualification of  GAMP5 Category 1 software tools. Skilled in writing computer system validation documents, assessing system change controls, conducting periodic reviews, system-related deviations, and testing generation.

Essential Duties & Responsibilities:

Generates and executes computer system validation documents like Requirement Specifications, Risk Assessments, Traceability Matrices, Validation Plans, Validation Summary Reports, Installation Qualifications, System Acceptance Testing, and User Acceptance Testing, along with completing periodic reviews. Generate and execute qualification protocols for GAMP5 Category 1 software tools. Generate, asses, initiate, and manage change control. Initiate and manage deviations and CAPAs. Create and modify System Operating Procedures (SOP) and Work Instructions (WI). Responsible for documenting activities following Good Documentation Practices (GDP). Review contractor validation documentation. Perform scheduling of activities for software validation activities. Other duties as assigned.

Supervisory Responsibilities:

N/A

Knowledge & Other Qualifications:

BS degree in engineering, computer science, or other science-related discipline. 4+ years of practical related experience in a GxP environment. Experience with GxP systems is required. Experience with validation is required. Ability to understand and follow written procedures. Computer literate with proficiency in Microsoft Office including Word, Outlook, and Excel. Good Documentation Practices and ALCOA+. Knowledge of 21 CFR Part 11 is required. Knowledge of GAMP 5 is preferred.

Other Characteristics:

Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality. Ability to have an innovative and dynamic approach to work. A self-starter able to work independently but comfortable working in a team environment. Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers, and others. Capable of performing other duties as assigned by Management. Authorized to legally work in the United States without visa sponsorship.

Physical Requirements/Work Environment/Travel Requirements:

Sedentary work. Exerting up to 10 pounds of force occasionally and/or carry objects. Sedentary work involves sitting most of the time. The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading The worker is not substantially exposed to adverse environmental conditions Will be required to work in a clean and/or sterile laboratory environment occasionally and wear personal protective equipment to include but not limited to: gloves, safety glasses or goggles, face shields, lab coats, aprons, ear plugs and mask to include respirators.

Limitations and Disclaimer:

The above job description is meant to describe the general nature and level of work performed; it is not intended as an exhaustive list of all duties, responsibilities, and required skills for the position. Employees we be required to follow any other job-related instructions and to perform other duties requested by their supervisor in compliance with Federal and State laws. Requirements are representative of minimum levels of knowledge, skills, and/or abilities necessary to perform each duty proficiently. Continued employment remains on an “at-will” basis.

Supernus Pharmaceuticals is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age or any other characteristic protected by law.