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Posted: Friday, January 5, 2018 2:07 AM

Job Description:/h3:
PSC Biotech is one of the worlds largest compliance consulting firms specializing in compliance consulting in the life sciences industry. We are currently seeking a Computer Systems Validation (CSV) Engineer to work in Phoenix, AZ. Candidates must have recent CSV experience within
Pharmaceutical/Biologics industries.
:Write Validation Protocols such as IQ, OQ and PQs
:Execute Validation Protocols such as IQ, OQ and PQs to ensure compliance and adherence with applicable guidelines
:Excel Spreadsheet Generation and Summary Report Writing for PQ studies
:Review and modify Standard Operating Procedures (SOPs)
:Generate test procedures to validate new or previously unvalidated processes
:Write risks assessments and applicable test scripts according to GLP and 21 CFR Part 11 compliance guidelines and the Validation Master Plan.
:Prepare validation summary reports for executed protocols.
:Communicate Computer System Validation approaches and requirements during planning/audits.
:Education: Bachelors degree in Engineering or related field
:Knowledge of industry validation standards : 21 CFR Part 11, GAMP 5.
:Eqiupment Validation experience in Lyophilization, Filler, Packaging, etc.
:Automation experience in PLC, FactoryTalk, etc.
:Experience in Empower Validation (CSV).
:Demonstrated understanding and hands:on experience reviewing technical documents, including, validation documents, IQ/OQ/PQ validation protocols and reports
:Strong communication, interpersonal skills, coupled with attention to detail, excellent review skills and analytical skillsCompany Description:/h3:
PSC Biotech Corporation is a global, employee owned, life sciences consultancy that performs projects and staff augmentation in the following disciplines: Engineering, Information Technology, Technical Services, Validation, Compliance, Regulatory Submissions, Clinical, Project Management and Quality Assurance. PSC Biotech, incorporated in 1996, has been performing projects globally for over 20 years.


• Location: Phoenix

• Post ID: 67713337 phoenix is an interactive computer service that enables access by multiple users and should not be treated as the publisher or speaker of any information provided by another information content provider. © 2018