Manufacturing Operations Specialist

4 weeks ago

Winnipeg, Manitoba, Canada Emergent BioSolutions Inc. Full time

Job Summary

Fosters a culture of continuous improvement and excellence in regulated manufacturing operations. Assumes shift leadership when Supervisor is not present. Performs and coordinates manufacturing, environmental monitoring, and equipment/facility cleaning/sanitization in a cGMP environment. Qualified trainer for manufacturing processes.

Responsibilities

  • Identifies and champions process improvement initiatives.
  • Assumes shift leadership role in the absence of the Supervisor. Independently directs the activities of other Manufacturing Technicians to meet production schedule requirements.
  • Ability to design manufacturing process studies and report on the findings.
  • Participates in cross-functional project teams.
  • Ability to lead and contribute to the implementation of routine and complex process improvement, document, and change initiatives.
  • Demonstrated proficiency in quality systems:
    • Perform root cause analysis to investigate manufacturing deviations.
    • Initiate and author Standard Operating Procedures and Batch Production Records (Document Management System).
    • Coordinate corrective actions/preventative actions.
  • Review all documentation generated as each step is completed for accuracy of calculations/data entry and completeness of process signature steps.
  • Qualified Trainer for Manufacturing process execution:
    • Adaptable to the learning style of the trainee.
    • Gives timely and candid performance feedback.
    • Coordinate training and progression plan for Assistant and Technician level employees.
  • Maintain training/competence on Technician and Lead Technician level job tasks and execute as required.
  • Execute and document procedural steps in compliance with cGMP standards, clean room behavior, and aseptic technique Standard Operating Procedures.
  • Maintain state of facility environmental control including: preparation of cleaning solutions, daily, monthly, quarterly, and annual cleaning of manufacturing surfaces and equipment per Standard Operating Procedures.
  • Performs daily assignments with minimal to no supervision.
  • Able to coordinate with Quality for straightforward manufacturing hurdles or at least provide a list of potential actions to remediate the issue for Supervisor/Manager to decide on.

Education, Experience & Skills


High school Diploma or equivalent is required; Pharmaceutical manufacturing diploma or Bachelors' degree in Science/Engineering is considered an asset.
Minimum of 4 years of related experience is required; Previous experience working in a regulated environment is required.
Knowledge of cGMP and CFR requirements
Ownership – Actively participates in self-development.
Accountability – Follows through on commitments.
Detail Oriented – Able to complete required tasks and associated documentation with minimal error.
Adaptability – Maintain positive attitude in a changing work environment.
Communication – Effectively communicate with all levels of manufacturing and support staff.
Participates in department/level meetings.
Escalates issues through the proper channels.
Able to work on ladders or at heights when required.
Ability to lift and move materials/equipment when needed.
Ability to pass a pre-employment medical and criminal background check.
Ability to adapt to and complete shift work including days, evening, and nights.
This role requires the removal of all jewelry, wristwatches, make-up, and any other non-essential items as per gowning requirements.


Pre-employment medical required.

As part of our team, you'll join talented and inspiring colleagues whose sense of purpose complements your own. We offer highly diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements, and an extensive benefits package. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy.

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