Chemical Process Operator

2 weeks ago

Cornwall, Ontario, Canada Pureoyl Healthcare Full time

Job description:

Position Title: Chemical Process Operator

Department: Manufacturing / Product Development

Reports To: Production / R&D Manager

Position Summary

The Chemical Process Operator will be responsible for carrying out pharmaceutical and healthcare manufacturing processes in compliance with cGMP, GDP, and regulatory requirements. The role includes operating equipment, supporting product formulation and optimization, assisting in product development, maintaining accurate documentation, and contributing to quality and regulatory compliance.

Key Responsibilities

Manufacturing & Operations

  • Operate, monitor, and maintain processing equipment such as reactors, blenders, filtration systems, incubators, and distillation units as per SOPs.
  • Execute batch operations for pharmaceutical and healthcare products according to approved batch manufacturing records (BMRs).
  • Weigh, measure, and dispense raw materials in compliance with GDP.
  • Perform routine cleaning and minor maintenance of equipment.

Product Formulation & Development Support

  • Assist R&D team in new 
    formulation trials, process optimization, and scale-up activities
    .
  • Support pilot-scale batches and technology transfer to production.
  • Provide feedback on process challenges to improve yields, efficiency, and compliance.

Documentation & Compliance

  • Prepare and maintain accurate records in line with 
    Good Documentation Practices (GDP)
    .
  • Document and control in-process checks, samplings, deviations, and process observations.
  • Maintain logbooks, equipment use records, and cleaning validation records.

Quality & Regulatory Compliance

  • Ensure all operations are performed under 
    Good Manufacturing Practices (cGMP)
    .
  • Participate in 
    regulatory inspections and internal/external audits
     (e.g., Health Canada, FDA, EU-GMP).
  • Follow Standard Operating Procedures (SOPs) and ensure strict adherence to validated processes.
  • Support Quality Management System (QMS) activities including 
    change control, deviation management, CAPA, and risk assessments
    .

Safety & Continuous Improvement

  • Adhere to safety protocols and proper handling of pharmaceutical raw materials and chemicals.
  • Participate in continuous improvement initiatives to optimize processes and reduce waste.
  • Ensure compliance with environmental, health, and safety (EHS) standards.

Qualifications

  • Education:
     Diploma/Bachelor's in Chemical/Pharmaceutical Technology, Chemistry, Biochemistry, or related field.
  • Experience:
     1–3 years of experience in 
    pharmaceutical or healthcare manufacturing
     (entry-level may be considered with strong technical background).
  • Knowledge of 
    cGMP, GDP, and regulatory compliance
     is mandatory.
  • Experience in handling incubators, process equipment, and in-process sampling is an asset.

Skills & Competencies

  • Strong knowledge of 
    formulation, scale-up, and process optimization
    .
  • Familiarity with 
    QMS activities (CAPA, deviations, change controls, audits)
    .
  • Excellent attention to detail and accuracy in documentation.
  • Strong problem-solving, troubleshooting, and teamwork skills.
  • Ability to work under regulated environments with cross-functional teams (R&D, QA, QC, Regulatory).

Work Conditions

  • May involve 
    shift-based or extended hours
     depending on production schedules.
  • Exposure to controlled cleanroom and chemical environments (PPE provided).
  • Requires standing for extended periods, material handling, and strict adherence to hygiene and gowning procedures.

Job Types: Full-time, Permanent

Benefits:

  • On-site parking

Education:

  • Bachelor's Degree (required)

Experience:

  • Chemical Process operator: 2 years (required)
  • Work Location: In person

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