Validation Engineer

Vertragsart:
Vor Ort
Start:
ASAP
Dauer:
6
Von:
Optimus Search
Ort:
Zürich
Eingestellt:
24.05.2018
Land:
flag_no Schweiz
Projekt-ID:
1559864

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Validation Engineer - Zurich - 6 month contract - €80-€90 per hour

Optimus Life Sciences are working with a global Pharmaceutical company based in Zurich. My client is seeking a validation engineer to ensure compliance with internal and external computerised system policies and regulations which includes Global Computer Validation Standards for manufacturing and Analytical Equipment. You will be responsible for developing and managing GXP system life cycle documentation, including Validation Plans, User Requirements (URS), Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), Validation Reports, SOPs, Change Control Documentation, Risk Assessments, Periodic Compliance Reviews and Validation Summary Reports.

Responsibilities:

  • Conduct Periodic Compliance Reviews for Computer Systems/Equipment.
  • Conduct Compliance Determinations and GxP Risk Assessments on systems for computer systems/equipment.
  • Maintain Computer Systems Register
  • Maintain RTMs for validated systems
  • Conduct Periodic Compliance Reviews for Computer Systems/Equipment to include all change control activities. In addition, various level of code review will be required.
  • Write and execute computer system validations
  • Spreadsheet validation
  • Maintain SOPs
  • Development of CSV and equipment specifications and executing Computer System validation, System Development Life Cycle (SDLC) and other pharmaceutical equipment/system commissioning/validation (IQ/OQ/PQ) protocols in accordance with Good Engineering Practices, GAMP, local SOP's, industry best practices and other industry related guidance documents.
  • Assess the impact of changes to cGMP equipment and methods and establish the applicable Validation Plan to ensure the validated status after changes.

Requirements:

  • Degree in a technical or scientific background.
  • At least 5 years experience in Manufacturing validation and the Pharmaceutical Industry
  • Working knowledge of cGMP regulations
  • In depth knowledge of process, packaging, facility, and cleaning validation
  • Quality and detail oriented with documentation skills