Program Manager, Calibration
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.
Job Description Summary
The Program Manager, Calibration within the Facilities department is responsible for developing and leading STEMCELL’s Calibration Management Program and the overall processes that impact the quality of the measurement results or affect the GMP compliance of the facilities, utilities, manufacturing, and laboratory equipment. This role requires a certified individual who has demonstrated success in establishing GMP compliant calibration programs with hands-on experience inspecting and calibrating equipment, in addition to delivering training to staff as a subject matter expert, to expand STEMCELL’s overall calibration capabilities at our facilities.
Duties and Responsibilities
Lead the development of the corporate in-house calibration management program in line with ISO, GMP, USP requirements and industry best practices to increase efficiencies and compliance.
Establish an in-house metrology laboratory.
Develop and maintain calibration management documentation, including SOPs, calibration methods, measurement data templates, and reports.
Liaise with equipment owners/representatives to provide guidance for establishing calibration ranges and tolerances based on process requirements and compliance standards.
Perform calibration in-house and/or coordinate and supervise qualified external service providers, as required.
Perform investigations and impact assessments in response to out-of-tolerance/equipment failure conditions and document outcomes in STEMCELL’s QMS. May include providing recommendations for product impact assessments.
Develop statistical requirements for corporate calibration management program
Perform statistical analysis of measurement/test data, execute troubleshooting activities, recommend solutions, and lead process improvements for the program.
Train and develop direct and indirect team members on the calibration management program, including technical procedures and developing a proactive calibration mindset in stakeholder groups.
Define, lead and execute on the assigned calibration projects and related tasks, including defining the scope, timelines, resource planning, etc.
Participate in corporate, customer, and regulatory audits.
Implement and adhere to company policies, SOPs, Quality and Safety Programs, ISO compliance, Good Laboratory Practices (GLP) and Good Manufacturing Practice (GMP) standards and regulations when fulfilling all equipment related activities.
Bachelor of Science or Engineering and/or diploma in instrumentation, certified as Calibration Technician (e.g. ASQ CTT).
Minimum 15 years of relevant experience, preferably in a regulated GMP manufacturing environment, leading a calibration program and team.
Proven ability of defining and implementing corporate calibration strategies
Experience in participating in compliance audits
Strong aptitude in mechanical, electrical, controls, and/or electronics.
Comprehensive knowledge of equipment calibration and related applications, including commissioning, test standards, troubleshooting, repairs and optimization of utilities, manufacturing and/or laboratory equipment.
Thorough understanding of regulatory documentation requirements and standard practices, ISO compliance, Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and Design Control and Workers Safety.
Internal customer-focused mindset with strong interpersonal and influencing skills. Proven track record in collaborating within a project environment.
Excellent communication skills (verbal, written and presentation) both in one-on-one and in group settings.
Attention to detail combined with the ability to execute at a high level with significant independence.
Team orientated – ‘one-team’ attitude is a must.
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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