Computer Systems Validation Specialist
Prometic is an established biopharmaceutical company with widely recognized expertise in bioseparations, plasma-derived therapeutics and small-molecule therapeutics development. Prometic offers its bioseparation technologies and expertise for large-scale purification of biologics, drug development, proteomics and the elimination of pathogens to industry leaders and uses its own affinity technology that provides for highly efficient extraction and purification of therapeutic proteins from human plasma to develop and commercialize plasma-derived therapeutics. Prometic is also active in developing its own novel small-molecule therapeutic products targeting unmet medical needs in the fields of fibrosis, as well as diabetes, anemia and autoimmune diseases. Headquartered in Laval (Canada), Prometic has R&D facilities in the United Kingdom ("UK"), the United States ("USA") and Canada, manufacturing facilities in the UK and Canada and corporate and business development activities in the UK, Canada, USA and Europe. Prometic's common shares (the "Common Shares") trade on the Toronto Stock Exchange ("TSX") under the symbol "PLI" and the OTCQX International under the symbol "PFSCF".
The IT department of Prometic is looking for a Computer Systems Validation Specialist, to work at its location in Laval, Quebec. Under supervision of the IT Director, the Computer Systems Validation Specialist will be responsible to plan, manage and provide guidance in the development, coordination and execution of computerized systems validation, operating in a manner, as intended, consistent with regulatory and manufacturing cGMP requirements.
The mandate of the Computer Systems Validation Specialist will be mainly to:
The selected candidate will preferably hold a Bachelor's degree in Computer Sciences or a related field with a minimum of 5 years' experience in Biotechnology, pharmaceutical or similar regulated environment industry. They will have in depth knowledge of FDA guidelines and Global cGMPs relevant to 21 CFR Part 11 compliance requirements and Global Computer Systems Validation and ISPE GAMP 5 guidelines.
The subsequent competencies would be considered valuable assets: Experience with validation projects at least with one of the following systems: ERP, LIMS, MES or QMS, experience with cloud and ERP systems is a plus, experience with IT infrastructure qualification.
The following criteria are also required:
Prometic offers a competitive compensation, a flexible work schedule and a casual working environment.
To apply, please send a cover letter and a copy of your resume to **@********.com with the following reference: #PLI-IT-1702. Prometic is an equal opportunity employer. Only chosen candidates will be contacted for an interview. For more information about Prometic, visit our website www.prometic.com.