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Aseptic Technician Level 1 - Afternoon Shift

  Cambridge, ON,  Canada |  Full time

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Posting Date :  2022-05-13

Job Identification :  10997

Department  :  Production

Reporting to the Production Supervisor, the Aseptic Technician Level 1 is responsible for cleaning, sterilizing and setting up the room and equipment in preparation for the aseptic manufacture of products, in compliance with cGMP, SOPs and Bimeda quality standards.

Key Role Responsibilities:

  • Ensures that all work is carried out in compliance with company Safety Policies, Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs).
  • Wears proper personal protective equipment and follows aseptic procedures when gowning, de-gowning and working in the sterile and controlled areas.
  • Reports any accidents, incidents and injuries or illnesses immediately and notifies manager of any hazards, unsafe acts or conditions in the workplace.
  • Cleans and disinfects doors, floors, walls, ceilings and filling equipment using aseptic technique with the correct chemicals, and cleaning equipment in critical and control areas following all applicable SOP.
  • Conducts the disassembly, product removal, changeover, functionality testing and cleaning and disinfection of fillers. Washes, reassembles and wraps equipment for autoclave loads.
  • Works closely with the batching staff to conduct Clean Room activities associated with CIP, SIP and product filtration.
  • Test runs equipment to ensure changeover of filling lines is correct and operational.
  • Loads and unloads dry heat sterilization oven and autoclaves.
  • Transfers sterilized equipment, components and bottles to each of the filling lines.
  • Conducts filtration of WFI for cleaning activities.
  • Documents all activities as they occur in log books and Production dockets in accordance with Good Documentation Practices (GDP) and Data Integrity Practices.
  • Stocks supplies and removes garbage as required.
  • Assists the Aseptic Technician level 2 with the training of new operators as required.
  • Other duties as assigned.

Competencies Required for this Role:

  • FOSTERING COLLABORATION/TEAMWORK- is the ability to work jointly with others or together especially in an intellectual endeavor; the ability and desire to work cooperatively with others on a team; as a team leader, the ability to demonstrate interest, skill, and success in getting groups to learn to work together. Builds partnerships for global performance.  Respects others.
  • EFFECTIVE COMMUNICATION - Is the ability to convey information to another effectively and efficiently, to listen – help facilitate sharing of information between people.  It is about understanding the emotional intention behind the information.  The ability to express oneself clearly in conversations, confirm understanding, communicate using data and facts.  Exhibit willingness to listen, and show respect for oneself and others in interactions with others.   express oneself clearly in verbal and business writing.
  • ATTENDANCE/PUNCTUALITY – Meeting expectations requires that the employee regularly reports for work on time, prepared to start his/her assigned duties at the appointed time.  Report-for-duty time is defined as readiness to perform the first assigned task at the scheduled start of a shift and employee does not leave assigned post early, works through the end of work hours.    Employee leaves and returns from scheduled breaks and lunch at designated times.
  • INTEGRITY/PERSONAL CREDIBILITY – Demonstrated ability and concern that one be perceived as responsible, reliable and trustworthy.
  • THOROUGHNESS/DETAIL ORIENTED – Ensuring that one’s own and others’ work ad information are complete and accurate; carefully preparing for meetings and presentations following up with others to ensure that agreements and commitments have been fulfilled.

What You Bring to the Role:

  • 1-2 years in a Pharmaceutical manufacturing GMP environment
  • High School Diploma or GED
  • Excellent math skills.
  • Good command of the English Language, verbal, reading and writing
  • Strong hand & eye coordination.
  • Able to lift and move heavy objects 20 – 30kg, visual acuity, manual dexterity, some repetitive movements.
  • Requires sustained motion of arms at all levels and fine finger activities including gripping, pinching and pulling.  
  • Must be able to work while wearing full protective gowning for entire shift.
  • High integrity, excellent attention to detail, ability to organize and prioritize, and work in team environment, take initiative

What We Have to Offer:

  • Competitive Hourly Wages
  • Paid Holidays
  • Competitive Vacation Policy
  • Medical, Dental, Vision Benefits 
  • Defined Contribution Pension plan - matching program 
  • Employee Assistance Program
  • Opportunities for growth and development

At Bimeda we are committed to fostering an inclusive, barrier-free and accessible environment. Part of this commitment includes arranging accommodations to ensure an equitable opportunity to participate in the recruitment and selection process. If you require an accommodation, we will work with you to meet your needs.

The job posting is available in an accessible format upon request by contacting the Human Resources Manager.

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