Company

National ResilienceSee more

addressAddressMississauga, ON
CategoryArchitecture

Job description

COMPANY SUMMARY:

RESILIENCE is creating the first sustainable ecosystem for advanced biopharmaceutical manufacturing. We’re building a robust, dynamic, and diverse network of manufacturing capability and talent – investing in innovation every step of the way.

We provide high-tech, end-to-end manufacturing and development solutions to ensure the medicines of today and tomorrow are accessible to all in need. This includes complex medicines, such as cell and gene therapies, viral vectors, and vaccines; as well as proteins and the next generation of medicines.

RESILIENCE believes in access to quality and innovation for all. Our adaptive facilities serve partners big and small. We continuously invest in R&D for next generation manufacturing and development, freeing our partners to focus on the discoveries that impact lives.

We offer customized and scalable processes, the highest quality and regulatory capabilities, and world-class facilities. Through manufacturing that’s faster, more flexible, and less risky, we safeguard the quality of critical medicines and protect the resilience of a vital supply chain.

JOB SUMMARY:

This job has the overall responsibility for leading and managing a team in accordance with established cGMP policies, procedures and objectives, and will assist with any of the validation requirements for all the base utilities to insure that licensing is achieved through the Health Canada, FDA or any other governing body.

MAJOR RESPONSIBILITIES:
  • Generate short term and long term scheduled preventive maintenance and calibration work plan.
  • Coordinate with equipment owning departments to ensure the availability and handover of equipment in cGMP manufacturing environment.
  • Review, confirm unscheduled work request and plan proactive work order accordingly.
  • Liaises with the work requesters and Facilities’ staff, to ensure job scope and requirements (tooling/parts etc.) to execute the work
  • Ensures that appropriate consideration is given to GMP compliance and EH&S requirements/permits
  • Receives and performs completed work order review prior to final entry into a computerized maintenance management system (CMMS). Ensures that feedback is provided to Facility Maintenance Supervisors on findings from work performed and mode of failure
  • Maintains work order planning system, estimates work hours, total duration and identifies relevant work group (calibration, maintenance, cleaner, contractor, etc.)
  • Assembles any necessary documents or drawings to perform work
  • Oversees and maintains bills of materials, equipment and system specifications, and preventative maintenance and calibration program in the CMMS
  • Enables and supports the Compliance Coordinator to effectively manage the progression of Deviations, Change Requests and CAPAs as well as providing data on training compliance, and SOP revision to the Director of the work group
  • Provide feedback on status (tracking) of work completion and generate monthly Overdue PM/CAL work order report.
  • Review backlogged work order reports with supervisor to expedite resolution
  • Support Major Change Projects, CMMS Replacement/Upgrade, ERP implementation.
  • Performs any other related duties as assigned
MINIMUM QUALIFICATIONS:

TECHNICAL KNOWLEDGE / EXPERIENCE:
  • University Engineering degree (i.e. Mechanical, Chemical or Process Engineering) with minimum three (3) years relevant experience is preferred; or, minimum five (5) year apprenticeship program or related College technical diploma with six or more years of relevant experience
  • Solid understanding of all trades (Mechanical, Electrical, Refrigeration, Building Services, etc.), current Maintenance best practices, preventative maintenance tools and processes, OHSA requirements
PREFERRED QUALIFICATIONS/EXPERIENCE:
  • Experience in a GMP manufacturing facility
  • Excellent written and verbal communication skills
  • Excellent supervisory skills are required, including supervision of maintenance personnel
  • Membership in Professional Association(s) related to this field (i.e. OACETT, P.Eng. etc.)
ADDITIONAL REQUIREMENTS:
  • Pre-employment medical and medical re-examination performed every 2 years or as per RESILIENCE’s SOPs,
  • This position requires vaccination for Hepatitis A and B
  • Regular day shift position, occasional weekends and extended shifts may be required for business support.
BEHAVIOURAL:

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

Teamwork: Working effectively and productively with others

Interpersonal Skills: Effectively communicating, building rapport, and relating well to all personality types

Goal Orientation: Energetically focusing efforts on meeting a goal, mission, or objective

Organization and Planning: Utilizing logical, systematic, and orderly procedures to meet objectives

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

Problem Solving: Anticipating, analysing, diagnosing, and resolving problems

Decision Making: Utilizing effective processes to make timely decisions

Written Communication: Writing clearly, succinctly and in a manner understood by the target audience.

Flexibility: Agility in adapting to change. Ability to work independently

Conflict resolution - Effectively broker solutions to resolve conflicts between individuals and groups.

National Resilience

Refer code: 1081615. National Resilience - The previous day - 2023-09-29 02:55

National Resilience

Mississauga, ON

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