Manager, Engineering

Accepting BioReady™: Yes
Category: Quality Control / Assurance
Education: Bachelor
Experience: 4-6 Years
Salary:
Location: Mississauga, ON
Posted: October 9, 2019
Closes: November 9, 2019

Job description:

Therapure Biopharma Inc. is an integrated biopharmaceutical company that provides contract manufacturing services for the client, development, manufacture, purification, and packaging of therapeutic proteins.

Manager, Engineering will determine the requirements and manage the engineering and automation department at Therapure. The scope includes technical leadership of engineering/automation, commissioning and qualification, and capital projects engineering. The position also requires periodic support to business development and strategic initiatives related to project development, master planning and plant design, start-up and handover to production, and ongoing operational support to manufacturing.

MAJOR RESPONSIBILITIES:

  • Lead technical aspects of design team for multimillion dollar fast track projects (“Projects”)
  • Develop processes for all stages of design, installation, fabrication, commissioning and qualification of engineered systems
  • Liaise with Project Managers, Procurement, Technical Services, Quality, and Validation Operations to facilitate execution of engineering related work
  • Oversee all related engineering processes, monitor and track technical performance and develop improvement plans
  • Develop, implement and optimize standards for engineering/automation
  • Support/oversee the production of the engineering start up batches & cGMP compliant batches for registration of products, and provide periodic support to production
  • Troubleshoot, optimize and develop continuous improvement plans for major GMP systems including PW, WFI, CA, Nitrogen, CIP, CS, SCADA, HISTORIAN, PCN, Oceasoft, and related
  • Oversee engineering drawing management, support regulatory audits, and establish plans to meet engineering compliance targets
  • Oversee IQ/OQ of new equipment systems, and support associated compliance initiatives related to Change Requests, Deviation Reporting and CAPAs for engineering related systems
  • 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
  • Ongoing review of skill sets within the engineering team and make recommendations for change as
  • Work closely & coordinate with national and international clients related to the design, construction and start-up teams for the project(s).
  • Provide frequent and regular updates to the senior leadership team.
  • Assume line management responsibility to manage a team of highly skilled scientific and production staff to achieve objectives
  • Develop process modelling tools and methods to facilitate design, review and modification of engineered
  • Provide leadership in project development of strategic projects including cell culture
  • 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 & manage vendors for engineering, construction and supply of equipment in a multi million dollar project
  • Upon completion of project phase, support ongoing operations with technical engineering/automation services
  • Act as project liaison with internal client Project and Venture Managers
  • Perform other related duties as assigned.

MINIMUM QUALIFICATIONS:

TECHNICAL KNOWLEDGE/EXPERIENCE:

  • 5 + years of related industry and functional experience in the pharmaceutical, biologics or plasma industry
  • 4 years university degree in a field of engineering with professional engineering designation
  • 5 years’ experience in cGMP compliance and knowledge of compliance in Good Manufacturing Practices
  • 5 years’ experience in an engineering role with experience in upstream and downstream processing
  • 5 years’ experience in process facility expansion, design/construction & commissioning, start-up and handover of equipment/processes
  • 5 years’ experience or prior knowledge in development of master plans for expansion of high tech manufacturing operations
  • 5 years’ experience in leading and/or working directly in a production environment or providing engineering or technical services to production

PREFERRED QUALIFICATIONS:

  • Experience in process design and development of biopharmaceutical processes

ADDITIONAL REQUIREMENTS:

  • Pre-employment medical and medical re-examination performed every 2 years will be required as per Therapure’s SOPs. Included as part of the medical is a respirator fit test (half mask), and pulmonary function test
  • This position requires vaccination for Hepatitis A and B

While we appreciate your interest in this opportunity, only qualified candidates will be contacted.

Therapure Biopharma Inc. will not be responsible for any agency referral fees arising from the use of resumes that currently exist in the recruitment database or have been forwarded to Therapure Biopharma directly or indirectly without an authorized agreement. Agency referrals will not be accepted unless approved by the Therapure Biopharma Inc. Human Resources team.

NOTE:All employment is conditional upon the completing and obtaining a satisfactory background check, including pre-employment medical (where applicable), educational, employment, references, and criminal records (for which a pardon has not been granted) checks.

Therapure 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. Please notify Human Resources for assistance.

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