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Project Manager/CSV Validation

ontario, ONTARIO
Project Engineer CSV
PharmEng Technology is currently seeking a Project Manager CSV for a project in Ontario, Canada  The position is available immediately conditional of a successful interview
 
Job Description:
 
  • Responsible for coordination and planning of assigned projects from CAR development to project closeout. Assuring that the engineering, construction, integrated commissioning and validation (ICV) satisfy the objectives of the CAR in accordance to approved procedures.
  • Leads project team including external contractors and coordinates their tasks through all project phases.
  • Ensures necessary communication within the project team (meetings, reporting) and coordinates interfaces outside of the project team with stakeholders, subject matter experts and customers.
  • Together with discipline leads, elaborates cost estimates and cost trends as well as the overall schedule, detailed schedules and ensures delivery to budget and milestones.
  • Develop and execute computerized systems validation protocols (IQ/OQ/PQ). Validation Summary report, Data Transfer and Integrity Testing Protocol.
  • Prepare validation documents: capture functional requirements for the client, change control, standard operating procedures (SOPs) and reports etc.
  • Solve problems during validation process and address/advise on issues such as deficiencies, deviations and change control etc.
  • Maintain personal training records. Ensure compliance with relevant regulations (e.g. cGMP/GLP/GAMP/GALP).
  • Complete assigned projects and tasks within agreed deadlines.
  • Assessment of client computer systems in terms of FDA 21CFR Part 11 compliance
  • Review existing SOPs and prepare draft to serve as the framework for Computer System Validation Projects
  • System Implementation ERP SAP
  • Project Management methodology
  • Works with procurement to acquire outside services and materials.
  • Participates in the qualification tasks (plan, controlling and reporting) in coordination with the Engineering and Quality organizations according to valid SOP’s and issues plant documentation according to site engineering requirements. 
  • Responsible for the management of capital projects less than $5 million
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Job Requirements:
 
  • Minimum 5+ years related industry experience required OR equivalent, including 1+ year(s)’ experience in pharmaceutical/biotech operations
  • Project Management experience
  • Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) preferred
  • Previous project, manufacturing or engineering experience.
  • Bachelor’s degree in Engineering or related field required.
  • Experience with SAP: SAP products, SDLC, ERP (Enterprise Resource Planning),
  • Familiarity with applicable US and worldwide regulatory requirements for the biotechnology industry (i.e. GMP and GLP).
  • Experience with Microsoft Word and Excel.
  • Willingness to travel
  • Applies functional and technical expertise across a range of processes or operational procedures  and knowledge of current trends to solve problems/issues, evaluate others’ work, and monitor progress
  • Continually seeks new functional knowledge and technical expertise
  • Serves as a credible resource when solving business problems, encouraging others to develop their functional/technical abilities
 
 
 
Thank you for your consideration and application!  We review all resumes and submissions, however, due to the sheer volume of requests that we receive, only successful candidates will be contacted
 
 
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