logo

View all jobs

Validation Process/Equipment

Ontario, ON
PharmEng Technology is currently seeking a Validation Process/Equipment  assist our team for projects in Ontario, Canada position is available immediately conditional of a successful interview.
 
Job Description:
  • Develop validation strategies, evaluate current processes and procedures
  • Write and execute Validation Master Plan (VMP).
  • Assess potential sources of variation in materials, processes, facilities, equipment, products and packaging processes that may impact consistent performance or product quality; where needed, design studies to characterize impact of identified sources.
  • Write and execute commissioning plan, Installation Qualification (IQ), and Operational Qualification (OQ) protocols and Final Reports.
  • Maintain an up-to-date knowledge of validation requirements, practices, and procedures
  •  Complete, review, and/or approve risk assessments for instruments, equipment, processes, and products.
  • Provide manufacturing process leadership through process improvement and optimization.
  • Development of Validation Plans, Process Qualifications and Aseptic Process Simulations (Media Fills) for various sterile dosage forms.
  • Working with the team to ensure all aspects of activity within the Process development and Validation group adhere to required policies and procedures, including safety and training.
  • Author and execute protocols as well as, writing comprehensive final reports including thorough resolution of protocol discrepancies.
  • Investigate/troubleshoot validation problems, as well as, conduct some statistical analysis of testing results.
  • Responsible for the validation (IQ, OQ, PQ) of various types of equipment systems: validation or requalification of autoclave loads, process equipment, filter integrity tester, depyrogenation oven loads, parts washer, vial washer, wireless temperature data loggers, temperature controlled chambers, lab analytical media fills, and Barrier isolators
  • Experience with sterilization process validation and chamber qualification (Freezer, Refrigerators, etc.) is required.
  • Evaluate new technological solutions determine feasibility, implementation and validation requirements.
  • Must have experience with the generation of deviations and CAPAs.
  •  Highly capable of developing Validation Plans and Process Qualifications
  • Working with a team to ensure all aspects of activity within the Process development and Validation group adhere to required policies and procedures, including safety and training.
  • Author and execute protocols, as well as writing comprehensive final reports including thorough resolution of protocol discrepancies.
  • Investigate/troubleshoot validation problems, as well as, conduct some statistical analysis of testing results.
Job Requirements:
  • Bachelor’s degree in a science / engineering field.
  • Experience with any of the following PLC driven systems: Air Handling Systems, Tangential Flow Filtration Systems, Industrial Chromatography Systems, Pharmaceutical Water Systems, Tank and Reactor systems, CIP and SIP Systems.
  • Highly capable of developing, executing and reviewing validation lifecycle protocols.
  • Knowledge of validation principles, standard concepts, practices, procedures and requirements in GMP regulated environments.
  • Proven capability to assess processes, equipment, and products for sources of variation, ability to analyze data and reach appropriate conclusions, and to perform and appropriately document deviations and investigations.
  • Experience with validation, and with knowledge of production.
  • knowledge of mixing, filling, filtration and sterilization process as it relates to FDA manufacturing
  • Knowledge of USP, EP, JP and FDA requirements.
  • Proven track-record of leading teams and project management experience is highly desired
  • Knowledge of media manufacturing process is a plus.
  • Familiarity with applicable US and worldwide regulatory requirements for the Pharmaceutical/biopharmaceutical industry (i.e. GMP and GLP).
  • Experience with biopharmaceutical process equipment and moist, dry, and VHP sterilization process validation.
  • Experience with Microsoft Word and Excel.
More Openings
Quality Assurance Consultant
Technical Consultant
Share This Job
Powered by