Job Description Summary
The Manager, Equipment Maintenance and Qualification within the Facilities department is responsible for developing and managing STEMCELL's Equipment Maintenance and Qualification Programs and the overall processes that impact the performance or compliance of the manufacturing and laboratory equipment.Job Description Duties and Responsibilities
- Manage STEMCELL global equipment preventive and corrective maintenance program and enhance equipment uptime, operation and performance utilizing industry best practices to increase efficiencies, cost and compliance.
- Ensure that maintenance, calibration and qualification activities are scheduled and performed in accordance with STEMCELL quality policy, ISO and cGMP guidelines, as applicable.
- Perform in-house and/or coordinate and supervise qualified external service providers to commission new laboratory equipment and commission, test, and start-up manufacturing equipment installations.
- Define, lead and execute assigned equipment projects and related tasks, including defining the scope, timelines, resource planning, etc.
- Lead technical team and provide guidance and support to team members in furthering their skills and motivations.
- Train and develop direct and indirect team members on the equipment management program, including technical procedures and developing a proactive maintenance mindset in stakeholder groups.
- Perform investigations and impact assessments in response to equipment failures or deviations during qualification events in STEMCELL's QMS. May include providing recommendations for product impact assessments.
- Liaise with equipment owners/representatives to identify, evaluate and recommend new equipment, instrumentation, monitoring and testing devices.
- Liaise with equipment owners/representatives to provide guidance for establishing maintenance programs and qualification criteria for equipment.
- Administer and train users of STEMCELL equipment Environmental Monitoring System.
- Manage the system, support, coordinate, be on call and respond to call out alarms during and outside office hours.
- Perform, support and coordinate the annual system testing, calibration and/or qualification/validation activities.
- Support in the development of documentation for equipment life cycle in partnership with the Manager, Reliability Engineer and Manager, Work Control Management:
- Equipment onboarding, identification and database.
- Equipment management including decommissioning.
- Qualification activities.
- Preventive and corrective maintenance.
- Support in ensuring the global equipment database and records are up-to-date and compliant to the requirements of the quality policy.
- Monitor team's work performance, ensuring all planned/scheduled and unscheduled activities are completed safely, reliability and in accordance with established maintenance, reliability and quality standards.
- Validate all work completed by contractors/vendors on equipment and approve payment in the financial system of record (SAP).
- Provide support in training personnel in the operation and maintenance of equipment.
- Support in the development of metrics for tracking and trending performance and costs of equipment management program in partnership with the Calibration Lead.
- Support STEMCELL calibration program and serve as backup or resource as needed.
- Participate in corporate, customer, and regulatory audits.
- Support in the evaluation, and monitoring of contracts with vendors and sub-contractors as required.
- Adhere to company policies, SOPs, Quality and Safety Programs, ISO compliance, Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) standards and regulations when fulfilling all equipment related activities.
- 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.
- 10+ years experience in a regulated health or device research or manufacturing environment.
- Excellent demonstrated knowledge of ISO and GMP regulation and audit practices.
- Bachelor of Science in Mechanical or Electrical or related engineering degree.
- Proven ability to implement new processes cross-functionally.
- Proven ability to influence peers to align to corporate equipment program.
- Experience in participating in compliance audits.
- Ability to train and develop others.
- Strong aptitude in mechanical, electrical, controls, and/or electronics.
- 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 role requires being fully vaccinated against COVID-19 as per STEMCELL's vaccination policy, the current recommendations by local health authorities and as required by public health orders in place from time to time, including any COVID-19 boosters as recommended by local health authorities and as required by public health orders in place from time to time.
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.
To apply please select the apply button. You will then be directed to a login screen asking you to set up an account. You must set up an account in order to apply.
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!
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