Technical Director - Process Validation - Alere - Ottawa

Job description
We are looking for highly motivated individuals with core strengths in many broad disciplines to fill leadership and staff positions at our Ottawa, ON corporate headquarters.

Position description:
Epocal is seeking a leader who will be responsible for developing and executing validation strategies and plans for the Epoc product line including biological, chemical and mechanical processes used to manufacture the product. They will support external contractors in executing required Process Validation activities in the short term, and extend and develop the Process Validation infrastructure within Epocal to fully meet regulatory and business requirements in the post-contractor era, and to continuously maintain a correct and complete Process Validation status thereafter. The management skills needed will include the ability to navigate the organization while gathering domain knowledge from internal clients, and sharing validation concepts and principles in a two way collaboration. This individual will also need to demonstrate a high commitment to quality compliance, while balancing practical organizational business risk.


Key Accountabilities and Major Activities:
Identify the core competencies, resources and trainings required to establish the organizational capability for Process Validation at Epocal.
Working with Human Resources, recruit and hire the appropriate team to meet the Process, Cleaning, Facilities, and Test Method validation site objectives in support of business needs.
Lead and complete a pre-existing first phase validation plan for one manufacturing line, and develop second phase plan for two manufacturing lines. Ensure complete Process, Cleaning, Facilities, and Test Method validation and qualification status.
In conjunction with Quality Assurance site leadership, sponsor and support the integration of Process Validation into Design Control.
Establish a re-validation periodic review program and lead validation review board at the site level.
Corporate expert in the theory, practical methods, and documentation of Process, Cleaning, Facilities, and Test Method Validation as practiced in Medical Device manufacturing.
Support external contractors in planning and executing Process Validation activities.
Provide day to day direction to validation team as well as Epocal partners to complete major functional objectives.
Mentor, coach and train validation team and Epocal associates to establish validation competencies.
Provide support for Validation and Qualification-related regulatory audits.

Desired Skills and Experience
Requirements-
Technical Skills / Business Knowledge:
Undergraduate degree required. M.Sc. or Ph.D. would be considered an advantage.
Background in Chemical Engineering with experience in portfolio management. Wider experience with Mechanical Engineering concepts and practice a definite asset.
Minimum of 7 years of industrial experience.
Significant and demonstrable process validation experience in a regulated industry such as pharmaceuticals or medical devices is required.
Demonstrated knowledge and skill in the use of statistical tools and the application of statistical software programs (JMP, Minitab)
Background in developing, writing and implementing process validation, test method validation, facilities validation, and cleaning validation plans, protocols and reports.
Ability to draft procedures related to Validation such as SOPs and Work Instructions.
Attention to detail while maintaining the ability to multi-task and manage project timelines is essential.
Ability to manage up to a diverse group of stakeholders with varying levels of experience in validation.

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