Process Validation (Upstream & Downstream)
PharmEng Technology is currently seeking a Process Validation (Upstream & Downstream)
for a project in Ontario, ON. The position is available immediately conditional of a successful interview
- Participates in and leads cross functional teams for tech transfer and process validation. May lead dedicated sub-teams and work as a point of contact for several programs.
- Serve as the Upstream and/or Downstream technical expert for the vector manufacturing process.
- Provide hands-on support of training runs and non-GMP Engineering Runs; perform hands-on experiments in the laboratory or manufacturing area as needed.
- Provide technical support of GMP manufacturing runs.
- Provide engineering technical support to equipment activities in your area of expertise (FAT, SAT, IQ/OQ/PQ). Assist in diagnosing technical issues with the equipment and provide recommendation/solution for their correction.
- Support Master Batch Record drafting with a strong understanding of equipment, critical process parameters, in-process testing, etc.
- Author and execute tech transfer plans, engineering studies, technical reports, change controls, and process validation plans/protocols.
- Work closely with Manufacturing, Quality Assurance, and other functions to successfully resolve deviations, investigations, change controls, CAPAs, etc.
- Use FMEA or similar risk-based approaches to troubleshoot processing issues.
- Ensure potential safety hazards are identified/shared and effective actions are rapidly implemented.
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
- BS/MS in Engineering or a related field with 7-10+ years of experience in manufacturing sciences, manufacturing, or related areas (or a combination of education and experience).
- Tech transfer or process validation experience is required, both are preferred. Thorough knowledge of engineering, chemistry, statistics, equipment design, process control, and process scale-up is desired.
- Familiar with FDA and EU regulations and GMP standards. Experience with agency filings and inspections is a plus.
- Prior cGMP cell or gene therapy manufacturing experience is highly desired.
- Ability to work in a matrixed-team environment, meet deadlines, and self-prioritize and balance work from multiple individuals and multiple projects.
- Exceptional verbal and technical writing skills; ability to provide focus and clarity; able to handle confidential information and material appropriately.
- Independently motivated, detail oriented and good problem-solving ability.
- Excellent organizational skills to multi-task in an extremely fast-paced environment with changing priorities.
- Willingness to take on other tasks as needed to support the facility start up and operations.