Manager, Engineering Services

A career at Resilience is more than just a job – it's an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. 

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JOB SUMMARY

As a key member of the FME leadership team, this role will lead the process engineering team to support site operations in all required functions. The position also supports business development and strategic initiatives related to process development, project development, start-up & handover to production, and ongoing operational support to manufacturing.

MAJOR RESPONSIBILITIES

• Lead the process engineering team to support production and facility maintenance operations to ensure critical facility and equipment related issues are resolved with focus and high prioritization
• Develop processes for all stages of design, fabrication, installation, commissioning, and qualification of engineered systems execution of engineering related work
• Oversee engineering processes, monitor system technical output, and develop process improvement plans
• Support / oversee the production of the engineering start-up batches and cGMP compliant batches for registration of products, and provide periodic support to production
• Troubleshoot, optimize, and develop continuous improvement plans for major GMP process systems including PW, WFI, CA, Nitrogen, CIP, CS, SCADA, HISTORIAN, PCN, Oceasoft, and related systems
• Oversee engineering drawing management, support regulatory audits, and establish plans to meet engineering compliance targets
• Manage and oversee workload and resource planning for the engineering team and make recommendations based on fluctuation in work schedules
• Prepare professional services RFPs, screen, evaluate, and oversee work performed by engineering consultants
• Ongoing review of skill sets within the engineering team and make recommendations for change, as required
• Work closely and coordinate with clients related to the design, construction, and start-up teams for the project(s)
• Provide frequent and regular updates to senior leadership
• Assume line management responsibility to manage a team of highly skilled staff to achieve objectives
• Work with business development, senior management, and investors to facilitate development of strategic initiatives
• Hire staff of highly skilled scientific and production skilled staff required for project implementation
• Select and manage vendors for engineering, construction, and supply of equipment
• Upon completion of project phase, support ongoing operations with technical engineering / automation services
• Collaborate closely with facilities maintenance department with full engagement of daily manufacturing support from the engineering team
• Performs any other job-related duties as assigned

MINIMUM QUALIFICATIONS  

• Extensive experience in the pharmaceutical, biologics, or plasma industry, including upstream and downstream processing
• Strong knowledge of cGMP compliance and regulatory requirements
• Proven background in process facility expansion, including design, construction, commissioning, start-up, and handover of equipment and processes
• Experience developing master plans for high-tech manufacturing operations
• Hands-on experience supporting providing engineering and technical services in a GMP manufacturing environment

PREFERRED QUALIFICATIONS

• Bachelor's degree in Engineering or equivalent
• Professional Engineering (P. Eng) designation
• Experience leading engineering teams
• Experience in process design and development of biopharmaceutical processes

BEHAVIOURAL

Demonstrated ability to apply the following behavioural competencies on the job:

Teamwork: Achieving extraordinary business results through people. Lead by example.

Leadership: Achieving extraordinary operational results through inspiring, encouraging and developing people

Flexibility: Agility in adapting to change, shifting priorities, and driving results

Organization and Planning: Utilizing logical, systematic, and orderly procedures to meet objectives.  Detail oriented, sense of urgency and accountability

Problem Solving:  Anticipating, analyzing, diagnosing and resolving problems in a manufacturing environment

Decision Making: Utilizing effective processes to make decisions

Interpersonal Skills: Effectively communicating, building rapport, and relating well to senior management, scientists, and scientific technical staff

This job profile provides an overview of the minimum requirements of the job and does not include all the duties inherent, included or associated with the job or with the performance of the job. The Company reserves the right to make changes to the job profile as it sees fit to meet the needs of the organization.

Resilience Biotechnologies Inc. (RESILIENCE), is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). Requests for accommodation can be made at any stage of the recruitment process. Applicants are asked to make their needs/requirements known to Human Resources.