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.
- Managed GMP protocols and reports for validation projects involving API changes, excipient changes, and equipment changes for over 15 clients
- Designed and supervised deployment of a quality initiative to prevent and avoid the use of non-validated equipment in GMP areas across the site
- Organized and designed template and documentation to support adoption of Continued Process Verification (CPV) at the site
- Led the adoption of staged acceptance criteria and implementation of ASTM E2709/E2810 in validation activities at the site
- Ensure that work is performed in accordance with applicable regulations, industry guidelines and practices, approved procedures and cGMP. Lead projects large in scope and have full technical responsibility for interpreting, organizing, executing and coordinating projects from small to large in scale.
- 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
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.
- 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.