Auftragsdetails

Our client requires multiple Computer System Validation Consultants for a 3 - 5 month, hybrid engagement. This client requires Engineers with CSV and Data Integrity experience to assist with ad hoc projects.Client requires Consultant to be on-site for the initial 6 weeks, then can work hybrid for the remainder of the project. Duties and responsibilities could include, but are not limited to:

• Spreadsheet validation
• Roche C311 Chemistry Analyzer
• Eurolab Workstation qualification
• Updated old macs to new software
• Mass spectrometry
• Orbitraps from thermo later
• HPLC qualification - Waters - acuity
• Then gap assessment of manufacturers IQ/OQ
• Process flows - make sure the process makes sense to the instrument

Qualified candidates must have:

• B.S./B.A. in Engineering, Science, Information Technology or related field.
• Three years of relevant work experience may be substituted in lieu of education.
• Minimum 5 years experience in the field of Computer System Validation.
• Minimum 5 years experience in related Pharmaceutical or Healthcare Industries.
• Experience in the validation of at least one computer system category: automation control, laboratory systems, quality workflow, ERP, clinical data.
• Possess effective written and oral communication skills; ability to write, type, express or exchange ideas of a technical nature by means of the spoken word; convey information/instructions accurately; receive detailed information through oral or written forms and to translate those instructions into physical execution of tasks.
• General business math skills.
• Working knowledge of Microsoft Word, Microsoft Excel, and other word processing programs as may be required by the position (PowerPoint, Access and Microsoft Project may be required) including but not limited to Visio.
• Ability to walk, stand and move about for long periods of time; work with equipment in the field, read, prepare and analyze data for development of reports; ability to sit and type for long periods of time; ability to read and assemble documents as required.
• Basic knowledge of FDA GxPs, FDA Guidelines, and European Guidelines (where applicable) and other regulatory requirements.
• Basic knowledge of industry best practice such as GAMP5, ANSI standards (S-95, S-88), and ASTM (E2500).
• Basic knowledge of 21 CFR 11, including ERES, predicate rule and legacy system requirements.

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***ProPharma Group does not accept unsolicited resumes from recruiters/third parties.  Please, no phone calls or emails to anyone regarding this posting.***