Operational Excellence Specialist, Production

**ABOUT THE COMPANY**

Our state-of-the-art GMP manufacturing facilities and laboratories in Greater Vancouver are home to a growing team of professionals who are inspired to develop advanced life-saving hemoglobin-based therapeutics for the well-being of people.

**POSITION OVERVIEW**

Reporting to the Manager, Production, the incumbent will be responsible for leading the implementation and sustaining of the operational excellence in the PD team. The incumbent will look for improvements and ensure compliance within the PD Team, by reducing the risks that can lead to non-adherence of planning or inefficiencies.

The incumbent will need to be flexible with their work hours and schedule, and may be required to perform shiftwork to fulfil manufacturing requirements. Pre-employment medical and medical re-examination may be required annually to fulfil regulatory requirements.

**1. Key Responsibilities**
- Perform evaluation on critical deviations, investigations, CAPAs, and Change controls
- Develop, monitor, and analyze production KPIs to drive behaviour and improvements
- Develop and coordinate studies related to critical deviations or necessary improvements or changes
- Develop, implement, and monitor the control charts
- Develop and follow up with stakeholders on progress/projects related to cleaning and process validation and periodic product reviews
- Support the transfer of technical knowledge to the PD teams on specific topics
- Participate in the operationalization and discussion of TT's (technology transfer) and process improvement projects to coordinate actions with the appropriate project/process owners to accomplish goals
- Assess the short/medium/long term risks for the proposed schedules from a compliance perspective
- Collaborate in national (internal and external) and international inspections and take ownership of the completion of observations/deviations
- Monitor the results of quality control analyses and environmental monitoring, from the verification of the results of analysis reports, aiming to ensure product quality
- Provide guidance, instructions, feedback, and training to other team members
- Contribute to the excellence of services, based on the commitment to the principles and concepts of quality
- Act as a change agent to lead team members in the engagement and sustainment of a continuous improvement culture
- Provide guidance, support, and monitoring of department activities, while aiming to ensure the effectiveness of the production processes
- Takes initiative to understand the market and industry best practices to update policies, projects, routines, and procedures related to PD
- Evaluate potential impacts on schedules, caused by events which cannot be predicted in advance and act to minimize or annul negative impacts
- Support the immediate manager in the development, implementation, maintenance, and reorganization of programs and special projects, through research and studies, adjusting standards and procedures
- Conduct assessments related to effectiveness and productivity, finding opportunities for improvement
- Immediately report to manager any conditions or deviations (relating to plant, equipment, personnel or any health condition) that may adversely affect the products and participates in investigation process
- Ensure strict implementation of company safety policies, SOPs and GMP regulations in PD
- Support production managers and act as first point of contact when a manager is absent or out of the office
- Act as Manufacturing Subject Matter Expert to provide information and collaborate with other departments
- Perform other duties as required

**2. Knowledge, Skills and Experience**
- Minimum 5 years of experience working in a pharmaceutical area, cGMP processing environment and/or combination of education and experience
- Post-secondary degree in Pharmaceutical Science, Biology, Biochemistry, Biotechnology, Applied Biology or equivalent related to the responsibilities
- Proven record of implementing and inspiring continuous improvement culture in an organization
- Previous experience of Lean/ Six sigma/ Kaizen (or other improvement processes) or Certification
- Good working knowledge of GMP and regulatory requirements for products in major markets
- Knowledge of KPIs and Pharmaceutical applied statistics will be an asset
- Integrated vision between Quality and Production with strong sense of pride in ownership
- Strong interpersonal skills and ability to work effectively in a team
- Flexible and adaptable to changing circumstance and challenges
- Strong communication, collaboration, facilitation, and influencing skills with ability to interact across all operation teams and at all levels of the organization
- Results oriented with the ability to effectively prioritize and manage multiple tasks and projects
- Strong problem solving and decision-making skills
- A self-starter with ability to take initiative, learn quickly, and think independently

WHY JOIN NBI?

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