Pharmaceutical Systems Specialist II

Overview: The incumbent will support all activities associated with the Systems Specialist II position. Additional responsibilities include advanced hardware support and software for qualified systems, managing larger projects, and developing protocols for validation activities.
Guidance: This position will require minimal dependency on senior members of this department for direction. Moderate final project decision-making will be performed with this position.Key Tasks:

Draft/execute/review validation protocols

Works with cross-functional teams on multiple validation projects

Supports qualified systems, both hardware and software
This individual will interact on a regular basis with the Quality Departments as well as various other in-house departments. There will be moderate interaction with outside vendors. Vendors will be contacted for troubleshooting issues.Responsibilities:
Develop validation documentation as well as execute required protocols
Support end-users on various qualified applications within allotted SLAs
Ensures validation documentation is completed timely and accurately
Evaluation of potential pharmaceutical applications
Vendor audits of acquired pharmaceutical applicationsJob Requirements
Experience:
5Qualifications:

Must have a college degree or equivalent

Must have a minimum of five (5) years experience in a regulated environment with three (3) years in an IT support role or 3 years with a quality certification

Must speak and write English fluently

Must be able to use Windows 2000/Windows XP systems

Must be able to create Microsoft Word documents, Excel spreadsheets and enter information into Access forms

Must be able to draft, execute and review an Installation Qualification, Operational Qualification and a Performance Qualification accurately and consistently

Must be highly organized

Must be able to review and develop SOPs accurately

Must be able to communicate all information in a concise and effective manner

Must have experience working under 21 CFR Part 11 and cGMP environment

Must be able to prepare project proposals and develop project plans

Must be able to learn and interpret new pharmaceutical applications

Must be able to integrate existing and/or new applications within the pharmaceutical environment

Must have moderate knowledge of Microsoft Excel, Word and PowerPoint

Must have intermediate understanding of Microsoft Project

Must have intermediate understanding of Microsoft Visio

Must have excellent proof-reading and writing skills for SOP review and creation

Must be able to draft/execute/review validation protocols

Must be able to work in a collaborative environment

Must be able to audit spreadsheets and document variances

Must be able to support moderate application and hardware issuesJOB PREFERENCESEducation and Experience:

Prefer having a computer-related or science degree

Prefer an A+ certification

Prefer a Microsoft certification

Prefer any other IT-related certification

Prefer having some quality assurance experience

Prefer experience with qualified applications

Troubleshooting

Creating validation protocols

Executing validation protocolsKnowledge, Skills and Abilities:

Advanced knowledge of 21 CFR Part 11 compliance

Advanced knowledge of cGMP

Advanced knowledge in creation/execution of validation protocols

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