Process and Cleaning Validation Specialist
PharmEng Technology is currently seeking a Process and Cleaning Validation Specialist
to join our team for projects in Canada, ON
- Ensures that all work is performed in compliance with SOPs, GLPs, and established safety standards.
- Reviews scientific literature and other documentation pertaining to assigned projects.
- May act on own initiative to request literature searches and updates as required.
- Documents all work and results of all assignments as required, including laboratory record books and forms, logbooks, and computer printouts.
- Assists with the training of other technical staff regarding laboratory and production techniques, SOPs, mass spectrometer instrumentation, software operating systems, maintenance, troubleshooting etc. Reviews FAT (Factory Acceptance Testing) and SAT (Site Acceptance Testing) procedures for approval.
- Verifies that all critical process and testing instruments requiring calibration are in a calibrated state. Executes all types of validation protocols
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 Science with a minimum of 5 years of experience in the pharmaceutical industry, production or Q.C. environment.
- Ability to learn new technologies and instrumentation in a fast manner and to apply problem-solving techniques.
- Ability to work in a team environment and with minimum supervision
- Good computer skills (spreadsheets, word processing etc.) and proficiency in automated data acquisition software.
- Working knowledge and understanding of regulatory requirements and guidelines such as ICH Q7A, HPFBI GMP and FDA CFR 21- 210 & 211.
- Good written and verbal communication skills. Excellent interpersonal skills, ability to coach others.
- Well-developed time and project management skills.
- Be able to select and evaluate effective cleaning methods and process.
- Have experience in selecting sampling methods and analytical test methods and Statistical Analysis.
- Have experience in establishing residue limits and sample acceptance criteria. Be familiar with CIP (clean-in-place) & SIP (steam-in-place) systems.