Director, Lab Instrumentation
Job Description SummaryThe Director of Equipment is responsible for overseeing the development and management of STEMCELL’s Equipment Requirements, Maintenance, Performance, Compliance and CQV (Commissioning, Qualification and Validation) Programs applied to a large and growing portfolio of biotech lab and manufacturing equipment located globally but concentrated in the Vancouver area.
They will oversee, develop, implement and maintain compliance, calibration focused programs, including but not limited to ISO, GMP, internal compliance standards, and other compliance requirements as they apply to everyday operations at STEMCELL.
Duties and Responsibilities
Direct and oversee all aspects of the Equipment, Compliance and Calibration teams globally.
Guide and vet User Group equipment requirements.
Assist with the equipment procurement.
Set, measure and oversee the global Equipment, Compliance and Calibration standards. Collaborate cross-functionally (and globally) to ensure that standards and organization needs are met.
Design, develop and execute strategies that ensure compliance and optimize efficiency of the Equipment Maintenance, Qualification and Calibration Programs. Ensure processes are compliant with ISO, Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP) and STEMCELL’s internal standards and requirements.
Support the Quality Management System according to ISO 13485 standards and relevant regulated and non regulated product regulations.
Develop, oversee, and report key performance indicators to measure and track progress of the equipment, compliance and calibration teams; identify opportunities for improvement through a self-inspection program and develop and execute on strategies to address compliance gaps.
Accountable the preparation and management of the operating and capital budgets for all existing and new equipment across numerous locations. Support the initiative for proper and timely forecasting, tracking, reporting and management of the quarterly and annual budget reviews for assigned cost centres.
Participate in annual goal setting for the assigned functions and team(s) to prioritize operational deliverables, projects and overall strategy.
Provide direct management, coaching and mentorship to the Equipment, Compliance and Calibration teams and enable progressive career development opportunities and a great employee experience.
Represent User Group equipment requirements for new build and expansion projects including coordination of engineering support, equipment team, building operations, building & equipment CQV, leading users through requirement briefs and Transfer-to-Operations.
Represent User Group Equipment requirements for Cleanroom Operations, Manufacturing and related obligations such as Steering Committees.
Lead and participate in cross-departmental initiatives to drive continuous improvement and set appropriate compliance expectations for various compliance tiers.
Host corporate, customer, and regulatory audits for facilities operations. Ensure employees are trained in audit best practices and are equipped to participate. Coordinate all necessary responses.
Contribute to the development of investment opportunity business cases with respect to Equipment expenses and resource needs.
May be required to complete and maintain necessary training to work with both regulated and non regulated products.
May be required to provide technical expertise and knowledge to other departments related to regulated and non-regulated products.
Perform other duties as required by the business.
Bachelor of Life Sciences, Mechanical, Electrical or related Engineering degree is required.
15+ years of experience in equipment and compliance with a strong aptitude in mechanical, electrical, controls, and/or electronics. Biotechnology, pharmaceutical or medical device industry experience is an asset.
5+ years of experience leading and managing a team with the ability to effectively delegate, mentor and develop staff and inspire others to reach their full capability, maximize their capacity and accomplish goals.
Experience in a professional cGMP manufacturing environment (preferably biologics).
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.
Experience with pharmaceutical GMP regulations 21 CFR Part 210 & 211 and ICH guidelines and interpreting regulatory documents such as CFRs, FDA, and ICH Guidance documents.
Demonstrated knowledge of ISO and GMP regulation and leading audit practices.
Ability to work collaboratively with senior management, external providers, business partners, etc. to achieve objectives; champions best practice, quality management and long-term sustainability.
Ability to think strategically / conceptually and collaborate cross functionally to solve complex problems effectively and ensure smooth execution of solutions.
Strong understanding of program / project management methodology, including scope, budget, schedule and resource planning, with particular emphasis on stakeholder engagement, communication and change management.
Detail-oriented with a strong work ethic and ability to work in an autonomous environment and adapt to changing priorities and deadlines.
Demonstrated experience building strong relationships with the ability to strategically partner cross-functionally and globally to advance strategic direction of the business.
Exceptional written, verbal and interpersonal communication skills; communicates in a clear, concise and organized manner; listens to others to obtain information.
Required to travel up to 10-15% of the time.
This role requires vaccination against COVID-19 as per the current recommendations by local health authorities, including any COVID-19 boosters as recommended by local health authorities and where available.
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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