Specialist, Manufacturing (Fixed - Term Contract)

ResilienceMississauga, ON
Onsite

About The Position

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. The Specialist, Manufacturing will assist in protein purification and manufacturing operations while following cGMPs, SOPs, and all company policies/regulations.

Requirements

  • 12 Month Fixed Term Contract
  • Pre-employment medical and medical re-examination performed every 2 years will be required as per RESILIENCE's SOPs
  • Included as part of the medical is a respirator fit test (half mask), and pulmonary function test
  • Occasional use of a half face respirator
  • This position requires vaccination for Hepatitis A and B
  • Job requires shift work, weekends and occasional extended shifts, and possible short notice schedule shifts changes
  • This position requires lifting/carrying up to 25kg
  • Direct contact with chlorine/alcohol based disinfectant agents
  • Demonstrated ability to apply the following behavioural competencies on the job: Standards: Strong desire to achieve and maintain required standards
  • Decision Making: Utilizing effective process to make decisions
  • Teamwork: Working effectively and productively with others
  • Interpersonal Skills: Effectively communicating, building rapport, and relating well to all personality types
  • Organization and Planning: Utilizing logical, systematic and orderly procedures to meet objectives
  • Goal Orientation: Energetically focusing efforts on meeting a goal, mission or objective

Nice To Haves

  • Science Degree or Technical diploma from an accredited college with relevant experience
  • Previous pharmaceutical or biopharmaceutical industry experience
  • Experience in filtration, cross flow filtration and chromatography
  • Experience in AKTA Ready operation
  • Experience with bioreactors
  • Experience with FIFO

Responsibilities

  • Performs all duties according to the SOPs and cGMPs and all other established safety standards and company policies.
  • Operates, among others, the following manufacturing equipment: Bioreactors, centrifuge, Bio Safety Cabinets (BSC) Chromatography skids (AKTA, OPTEK, others) UF/DF, TFF systems, as well as nanofiltration systems
  • Perform filtration using various methods and filter sizes.
  • Receiving materials for manufacturing following FIFO (First in First Out)
  • Parts Wash and Autoclave parts for decontamination and terminal sterilization
  • Execute CIP/SIP (Clean in Place/Steam in Place) on process skids and vessels
  • Maintains housekeeping standards in the manufacturing area including cleaning of the process suites as guided by internal procedures.
  • Documents and records all necessary information/data as per SOPs and cGMPs requirements (i.e. observations, test results).
  • Notifies Specialist II, Lead or Supervisor, if a product defect or other problem occurs.
  • Participates in all manufacturing operations related to Upstream and Downstream processing any other manufacturing duties as assigned.
  • Utilizes HMIs and computerized systems to operate various skids and production equipment.
  • Performs all other job-related duties as assigned.

Benefits

  • annual cash bonus program
  • RRSP/DPSP with a generous company match
  • competitive healthcare, dentalcare, vision care, life, LTD, and AD&D benefits package
  • fertility healthcare and family-forming benefits
  • paid vacation
  • paid holidays
  • pregnancy and parental leave top-up plan
  • tuition reimbursement
  • employee referral program
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