Job Description Summary
Are you an engineer with a passion for quality and experience executing risk-based validation programs in a regulated environment? If so, this is a great opportunity for you! As a Quality Assurance Validation Engineer you will lead the implementation, maintenance, and continued verification of a risk-based lifecycle approach to processes, analytical methods, equipment, and off the shelf (OTS) software assurance. This role is also responsible for generating and supporting higher level project documentation, such as master plans, schedules, risk assessments, protocols, and summary reports within a biotechnology and medical device cGMP regulated environment. This is a highly collaborative position, and you will work in the full range of project phase execution, including CQV and project hand-over activities, within a variety of departments, such as Manufacturing, Quality Control, Process Development, and Instrumentation. This is your chance to work alongside motivated and intelligent individuals who are passionate about the work they do to support life science research. If you are looking for a stable career with Canada's largest biotechnology company, combined with opportunities for growth in a fast paced environment, this is the team for you!Job Description Duties and Responsibilities
Qualifications & Requirements
- Apply the Risk Management program per ISO14971 with applied statistical techniques.
- Responsible for the development of metrics that report on the effectiveness of processes, status of improvement opportunities and progress against performance objectives to drive continuous improvement.
- Participate in the Process Performance Qualification (PPQ) conformance lot manufacturing that includes increased testing to demonstrate acceptability of the developed formulation and process.
- Prepare, review and/or coordinate the execution of validation, commissioning and qualification documentation.
- Ensure appropriate procedures, processes and policies are established and implemented for quality assurance activities to assure compliance with applicable medical device and/or biopharmaceutical regulations and products.
- Work cross functionally with other groups to establish a program to collect and analyze product and process data to evaluate the state of control of the process/es.
- Educate, train, advise and coach other employees to ensure adherence to all applicable quality standards for assigned areas.
- Bachelor's Degree in Biomedical Engineering or equivalent, in combination with suitable experience in a validation job.
- Practical application of risk management commensurate to the respective statistical significance of risk rankings and definitions.
- Knowledge of Quality System regulatory requirements.
- Experience in utilities, facilities, and equipment qualification (Manufacturing, QC Lab, Controlled Temperature Chambers mapping and monitoring), as well as software assurance.
- Experience in validation of processes, cleaning procedures, QC test methods, and shipping.
- Excellent technical report writing and strong ability to understand and analyze technical documents.
- Familiarity with Continued Monitoring and Improvement concepts.
- Strong project management and time management skills, and has worked closely with multiple internal and cross-functional teams.
- Professional certifications such as ISPE membership, Project Management, ASQ/ Six Sigma certification or equivalent is considered an asset.
- Risk Management (ISO 14971).
- Design of Experiments (DOE), statistical methods, and metrics in PQ.
- Studies in formulation and process development.
- Trending of material, process, and product data in monitoring and maintaining validation.
- IOPQ documentation development, execution and reporting.
- Quality Control Test Method development and validation.
- Software assurance.
STEMCELL Technologies Inc. is a privately-owned biotechnology company based in Vancouver that helps power leading-edge life science research around the world. Scientists performing stem cell, immunology, cancer, regenerative medicine and cellular therapy research are among those who rely on our cell culture media, cell separation products, instruments, ancillary reagents and contract assay services. We create novel, useful, standardized products of unfailing quality and deliver them to more than 70 countries via our many regional offices plus distribution centres in Vancouver, Seattle, Grenoble and Singapore. Driven by our love of science and our passion for quality, we see ourselves simply as "Scientists Helping Scientists" - standing by our customers to provide outstanding products, technical support and training. We have over 1000 science-oriented employees globally, including 250 PhDs/MScs, with most others holding a BSc or engineering degree. STEMCELL is proud to be the largest Biotechnology employer in Canada.
This is an opportunity to work with highly motivated colleagues in a science-oriented, creative and dynamic environment. We offer a competitive salary, excellent benefits and significant career development opportunities.
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Create an account by selecting the create account button. You will then be asked for your email and to create a password. Your Password must be eight characters long, contain at least one special character, one capital letter, and a number. Once you have created your password you will be asked to upload your resume. Uploading your resume will provide the ability to auto-populate your application with information from your resume. If you prefer to manually complete all of the fields in the application you can do this by clicking next. You can upload your cover letter as an attachment in the attachments screen. Thank you for your interest in STEMCELL!