Corporate Validation Manager Jobs

• Communication bus (CAN / LIN / other) operation knowledge and experience in using diagnostic tools.

Responsibilities include but not limited to:

Requirements:• Bachelor of Science in Mechanical or Electrical Engineering or equivalent (Materials /Chemical/ Civil/ Aerospace/Computer) from an ABET accredited University.

• 5 years' experience in electrical systems design, development, or test engineering.

• Experience in validation of complex systems.

• Experience developing DVP&R and detailed electrical test procedures.

Qualification of new equipment/processes, computer-related system qualification and calibration program management.

Communicating and reporting the status of each project to the management and department that sponsors the project.

Ensuring that the Validation department meets budget provided by Senior Management.

Five years pharmaceutical industry experience.

Leading participant in conducting process risks analysis and process hazard analysis.

Developing, maintaining, and updating the Validation Master Plan (VPM) for the overall project.

Successful completion of a post-secondary Degree or Diploma in Project Management; or an equivalent level of education and experience.

Project Management Professional (PMP) Certification

Experience in strategic planning, change management and risk management.

Lead the development of and grow corporate capacity in the area of formal project management.

Assist the Chief Administrative Officer and Senior Management in the timely accurate maintenance of strategic and tactical planning efforts.

Minimum 5 years’ experience as a Project Manager

Management or technical leadership experience

Implement change control and issue management processes

Lead a team of engineering staff, manage assignment, monitor workload, and drive post-Si activities.

Establish deliverable requirements, milestones, and metrics

Provide status and issue updates to internal managers and program leadership

Knowledge of computer hardware architecture (CPU/APU, x86, PCIe, memory, bus logic) and software architecture (driver, bios, firmware usage)

Sound knowledge of Project Management, Statistical Process Control (SPC) skills and Six Sigma methodology is an asset.

Support the culture of pro-activeness for the management of industrial processes.

Support the integration of science and risk-based approaches within the framework of lifecycle management of cleaning processes.

Manage and coordinate the Cleaning Validation Team, including technologist(s) and contractor(s).

Bachelor's degree in Sciences or Engineering, with 4+ years of relevant experience; OR

Master’s degree in Sciences or Engineering, with 3+ years of relevant experience.

12+ years of engineering experience with 3+ years in leadership or Management role.

Reporting project status to Director and Project Management Team. Presenting technical information to internal and extern groups

Experience working and leading a team in a lab environment and knowledge of relevant test equipment and protocol analyzers.

Experience in IC, FW and SoC validation.

Experience in defining comprehensive test coverage at sub-block and system level.

Experience in defining and building HW and FW test infrastructure.

Three to six years of related experience in validation and quality management systems, process design and control.

Sound organizational and management skills are required.

Knowledge of accreditation requirements of organizations, such as AABB, OLA and FACT is considered an asset.

Ensure that processes and procedures comply with current regulations and Canadian Blood Services policies and requirements.

Liaise and consult with other Canadian Blood Services sites, departments, and staff to share knowledge and promote team culture.

Experience working a in pharmaceutical, medical device or biologic manufacturing environment under GMP regulation is essential.