Biomedical Engineer jobs in Mississauga, ON

Position Summary:

Sr Mgr, Donor Center Systems & Validation is responsible for the strategic leadership , governance, development, configuration, validation and lifecycle management of donor center systems, equipment, and computerized applications supporting the plasma collection operations across Canada.

Position Objective:

Sr Mgr, Donor Center Systems & Validation oversees the Blood Establishment Computerized System (BECS) configuration and development function, as well as the validation teams responsible for freezer validations, equipment qualification, computerized system validation (CSV) , and software validation protocols. They will ensure that systems and equipment are appropriately configured, qualified, validated, documented, and maintained in a state of compliance throughout their lifecycle.

This position works in close partnership with Operations, Quality Assurance, Regulatory Compliance, IT, Engineering, Facilities, Medical, Training, and Global Corporate teams to align and/or establish standardized processes, strengthen technical and operational controls, and ensures systems changes and equipment implementations are executed in a controlled, risk-based, and compliant manner.

They will drive the development of a sustainable systems and validation operating model that supports current operational requirements, regulatory commitments, business growth, and the expansion of plasma collection capabilities across the Plasma Canada Donor Center network.

Position Responsibilities:

Donor Center System & BECS Configuration:

- Provide strategic and operational leadership for BECS configuration, development, administration, and related donor center applications.

- Oversee the evaluation, prioritization and implementation of business requests for system changes, enhancements and new functionality.

- Translate business requirements into scalable configuration solutions that support donor center workflows, operational efficiency, data integrity, and regulatory compliance.

- Lead the assessment of system changes, including business impact, technical feasibility, risk, master data requirements, and downstream operational implications

- Establish and maintain a structured Voice of Customer (VoC) process, including request intake and prioritization portfolio

- Ensure appropriate configuration controls, testing documentation, traceability, and approvals are available and align with quality GMP processes

- Coordinate with IT Teams, global system owners, software vendors, and third-party providers to deliver system enhancements and resolve technical issues

.- Oversee application lifecycle management, including upgrades, releases, maintenance, incident resolution and continuous improvement.

- Establish and maintain a network of application super users and subject matter experts to support effective system utilization and knowledge transfer

- Ensure appropriate system access controls, configuration, documentation, data integrity, safeguards, and system governance are implemented in partnership with IT and Quality.

- Evaluate emerging system capabilities and identify opportunities to improve donor center performance, compliance and quality profile, standardization, reliability, and user experience.

Freezer Validation & Equipment Qualification:

- Define validation requirements. Ownership, escalation pathways, and decision making authority in partnership with Quality and other relevant stakeholders.

- Lead the field validation team responsible for the qualification and validation of freezers and other critical equipment supporting plasma collection, storage, and product integrity.

- Ensure validation activities are conducted according to approved protocols, with appropriate management of deviations, corrective and preventative actions (CAPAs), and change controls.

- Apply risk based principles to prioritize validation work according to donor safety, product quality, regulatory compliance, data integrity, operational continuity, and business impact.

- Partner with Corporate Quality and IT on the development, review, approval execution, and reporting of freezer validation protocols, including applicable temperature mapping, performance qualification, and operational testing.

- Ensure equipment qualification and validation activities are appropriately risk-assessed and aligned with approved intended use, manufacturer requirements, company procedures, and applicable regulatory expectations.

- Align with Corporate Quality on consistent approaches for equipment qualification, including IQ, OQ, and PQ, where applicable.- Oversee validation schedules, resource allocation, protocol execution, deviation resolution, and timely completion of validation reports.

- Partner with Operations, Quality, IT, Facilities and vendors to resolve technical issues and ensure consistent execution of validation requirements.

- Maintain visibility of validation statuses, outstanding activities, emerging risks, and remediation priorities across the Plasma Canada Donor Center Network.

- Partner with Quality to support internal audits, external audits, regulatory inspections, and the timely resolution of findings.

Computerized System Validation (CSV) & Software Validation

- Partner with IT and Quality on the development and execution of a comprehensive computerized system validation framework aligned with applicable regulatory requirements, company procedures, and risk-based validation principles.- Oversee the execution of validation strategies and protocols for new and existing computerized systems and software applications.

- Ensure appropriate assessment and documentation of system changes, upgrades, patches, configuration changes, and periodic reviews to maintain validated status.

- Partner with IT, Quality, System owners, and 3rd Party vendors to establish clear responsibilities for system development, testing, implementation, and ongoing maintenance.

- Identify opportunities to simplify workflows, eliminate redundant activities, improve documentation quality, and reduce validation backlogs without compromising compliance.

- Use trends in system incdients, configuration requests, equipment failures, validation deviations, and audit findings to identify systemic improvement opportunities.

- Support the introduction of new technologies, equipment, applications, and operational capabilities through controlled implementation and appropriate qualification or validation.

Required Skills, Qualifications and Experience:

Qualifications:

o Bachelors degree or higher in Engineering, Computer Science, Information Technology, Life sciences, or a related technical discipline

o Professional Quality Assurance, Regulatory Affairs, Validation or related certifications or a relative field is preferred

o Candidates with an associate degree or technical qualification and substantial progressive experience in validation, equipment qualification, or pharmaceutical/biotech operations may be considered.

Required Skills:

o Strong knowledge of donor management, or regulated operational system configuration and administration.

o Understanding computerized system validation and risk-based software validation methodologies.

o Experience with relevant GxP principles and applicable regulatory guidance for computerized systems and electronic records.

o Change Control, deviation management, CAPA, risk assessment and validation lifecycle management.

o Understanding of applicable Health Canada requirements and relevant industry standards governing plasma collection, product quality, equipment and computerized systems.

o Knowledge of vendor contract management, service-level agreements, budget management, and capital expenditure planning.

o Demonstrated ability to build capable teams, develop technical talent, and establish accountability.

o Strong analytical, organizational, communication, and problem solving capabilities.

Experience:

o Requires 5-10 years of proven experience in validation, qualification, engineering, quality assurance, or technical operations within a regulated environment or a related technical field.

o At least 2-3 years of experience leading validation projects, cross functional teams, or technical initiatives.

o Demonstrated experience with leading technical teams responsible for computerized systems, system configuration, equipment qualification, validation, or related regulated functions.

o Experience with validation lifecycle documentation, risks assessments, change control, deviations, CAPAS and audit readiness.

o Experience managing complex cross-functional projects involving Operations, Quality, IT, and external vendors

o Experience managing competing priorities, validation backlogs, resource constraints, and time-sensitive remediation activities.

o Experience working in a regulated, healthcare, pharmaceutical, manufacturing, or similar controlled environment is preferred.

Pay: $175,000.00-$200,000.00 per year

Benefits:

• Dental care
• Disability insurance
• Life insurance
• Paid time off
• RRSP match
• Vision care

Ability to commute/relocate:

• Toronto, ON: reliably commute or plan to relocate before starting work (required)

Experience:

• regulated environment: 5 years (preferred)

Work Location: In person