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Job Description

Job Description

Salary : OVERVIEW

As a Validation Specialist II you will be responsible for generating SDLC documentation and validating / qualifying the systems used to develop and / or manufacture products within our assigned client base. You will ensure systems are running according to necessary specifications and operate within regulations to ensure data integrity and the production of quality products.

RESPONSIBILITES

• Execute multiple large, assigned projects within our clients needs.
• Coordinate the development of new processes or troubleshoot existing ones.
• Generates System Development Life Cycle documentation, including, but not limited to : Impact Assessments, User / Functional Requirements, Design / Functional Specifications, Traceability Matrix, ERES Assessments, Development Testing documents, Factory Acceptance Tests, Site Acceptance Tests, Installation and Operational Qualification Protocols, Commissioning documents, and Reports
• Schedules and executes validations / qualifications per Standard Operating Procedures (SOPs) and regulatory guidelines.
• Coordinates and communicates all testing within company resources and affected functional groups and evaluates test results.
• Executes equipment, facility, utility, computer system, and Automated Process Control validation studies to include protocol preparation, scheduling, protocol execution, analyze data and compose a final report.
• Participates and presents data in Customer, Corporation, and Internal audits.
• Thorough understanding of risk based validation for computerized systems, industry standards and best practices for computer system validation.
• Participates in developments / improvements to validation programs as needed to remain current with cGMPs and industry standards.
• Participates in teams assembled to specify, install, validate, troubleshoot and maintain systems and equipment.
• Conducts Validation deviations and / or participates in deviation investigations to identify root causes and define corrective and / or preventative actions (CAPA)
• Apply validation knowledge for manufacturing / packaging / utilities equipment in the to pharmaceutical / medical device / food and beverage industries.
• Perform all necessary engineering analysis and submit recommendations, as required.
• Create project documentation and procedures (SOP) to meet with customer requirements.
• Create acceptance criteria and conduct acceptance tests, if applicable.
• Manage the deliverables to agreed schedule and scope of work.
• Maintain excellent communications with upper management and colleagues of other functional areas to assure consistency with customer policies, procedures, and processes.
• Participate in staff meetings, as requested, and provide periodical project status reports.
• Any other duty assigned by supervisor, related to project, company or client needs.

QUALIFICATIONS

PREFERRED QUALIFICATIONS

PHYSICAL / MENTAL REQUIREMENTS

Moriah Engineering Solutions is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion, ancestry, national origin, age, gender identity, gender expression, sex / gender, marital status, sexual orientation, physical or mental disability, medical condition, military / veteran status, basis ofgenetic information, or any other group protected by law .