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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.
Responsibilities
: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.
Requirements
: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.

Source: https://www.tiptopjob.com/jobs/76731283_job.asp?source=backpage


• Location: Phoenix

• Post ID: 67713337 phoenix
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