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Validation Specialist

Company: PCI Services Limited
Location: Philadelphia
Posted on: November 11, 2019

Job Description:

I. Essential Functions: The main functions of a Validation Specialist are focused around the qualification of pharmaceutical packaging equipment and validation of the associated processes run on this equipment. These functions include generation and execution of protocols on packaging equipment, generation and execution of process validation protocols, assistance in customer audits, and determination of customer validation needs. The successful candidate will manage multiple projects under moderate supervision. This position provides technical and project support to the Sales Associates, Customer Service, Project Management, Engineering, Production, Quality Assurance, and to our customers. II. Specific Duties, Activities and Responsibilities A Validation Specialist is expected to lead the business beyond of the normal scope of task-based project validation. Knowledge, experience, personal drive, and creativity will motivate this individual to present new ideas to senior management that will affect the direction of the organization over the next years. These ideas could be focused around: Innovation of validation processes and tasks Validation trends/standards in the pharmaceutical and contract packaging industries Hidden opportunities within existing business or customer requests Standardization/harmonization/streamlining of validation activities A Validation Specialist will perform the following activities under moderate supervision. Some travel (a few days a year) may be required to meet with customers and/or vendors. Analyze customer and business needs in determination of a validation strategy. Conduct and/or participate in customer meetings and attend off-site meetings. Interact with Sales, Engineering, Customer Service, Project Management, Production, Quality Assurance, and customers to determine requirements for new projects Creation of protocols/protocol templates (IOQ, OQ/PQ) and validation standards Review and approve User Requirement Specifications, Functional Specifications and Engineering Study Protocols Participate in customer audits and annual product reviews Prepare Validation Plans and Validation Reports Prepare Equivalencies and Stability protocols Review and possibly assist in Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) to qualify equipment Assist in the Change Control process (TrackWise) Coordinate validation efforts with mechanics, operators, and engineering Responsible for the administration, implementation, and project management of assigned projects, including using standardized methodology. Research new trends and standards in packaging validation Mentor Validation Coordinators Review and approve documents written by others in the Validation department III. Knowledge/Skills, Requirements: Experience with development and execution of validation protocols for process, equipment, cleaning, and computer systems in the pharmaceutical and/or medical device industry Ability to work on multiple projects at the same time Ability to meet aggressive timelines Good interpersonal/teamwork skills Effective communication skills (verbal and written form) Effective at leading project teams and interfacing with customers and operations personnel Proficient in the use of computer software - Microsoft Windows, Microsoft Word, Microsoft Excel, Microsoft Access, and Microsoft Power Point Must possess and demonstrate motivational and leadership qualities Must possess excellent problem solving and analytical skills Must be well organized along with being detail and multi-task oriented Knowledge and experience in cGMPs and FDA regulations Knowledge of Six Sigma, DOE, and other improvement techniques a plus Requirements Education or Equivalent: (Minimum required to perform the job) Bachelor of Science in Engineering or Science required 2 - 3 years relevant experience in equipment, process, computer and/or cleaning qualification/validation Packaging, Pharmaceutical, Bio-Pharmaceutical, and/or Medical Device background is preferred Business Environment: Office and Production floor environment.

Keywords: PCI Services Limited, Philadelphia , Validation Specialist, Other , Philadelphia, Pennsylvania

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