Our client in Victoria is seeking an experienced Commissioning and Qualification Engineer. The successful candidate will play a pivotal role in planning, executing, and overseeing commissioning and qualification activities in adherence to industry standards and regulatory guidelines.
Responsibilities:
• Execute qualification and commissioning activities, including protocol preparation, execution, and report generation.
• Maintain and calibrate qualification/commissioning test equipment.
• Review and manage departmental documentation for regulatory submissions.
• Support other PALM (Process Automation, Laboratory, and Manufacturing) activities as required.
• Work collaboratively with Process Engineering, Project Delivery, Execution System, PALM Validation, PALM Stability, Value Streams, R&D, and QC staff to ensure efficient planning and delivery of activities
• Actively participate in problem-solving initiatives and identify opportunities for process optimization.
• Assist in HS&E Risk Assessments and contribute to safety enhancement projects.
Skills & Experience required:
• Education: Bachelor’s degree in a relevant science or engineering discipline (or equivalent experience).
• Experience: Previous experience in commissioning, qualification, or validation within the pharmaceutical or biotechnology industry is highly desirable. Proficiency in Microsoft applications is required.
• Strong understanding of cGMP and qualification/commissioning principles.
• Familiarity with industry guidance documents and standards.
• Excellent verbal and written communication skills.
• Effective presentation, interpersonal, and time management abilities.
• Strong problem-solving and negotiation skills.
• Customer-focused with the ability to manage changing priorities and multiple tasks efficiently.
Responsibilities:
• Execute qualification and commissioning activities, including protocol preparation, execution, and report generation.
• Maintain and calibrate qualification/commissioning test equipment.
• Review and manage departmental documentation for regulatory submissions.
• Support other PALM (Process Automation, Laboratory, and Manufacturing) activities as required.
• Work collaboratively with Process Engineering, Project Delivery, Execution System, PALM Validation, PALM Stability, Value Streams, R&D, and QC staff to ensure efficient planning and delivery of activities
• Actively participate in problem-solving initiatives and identify opportunities for process optimization.
• Assist in HS&E Risk Assessments and contribute to safety enhancement projects.
Skills & Experience required:
• Education: Bachelor’s degree in a relevant science or engineering discipline (or equivalent experience).
• Experience: Previous experience in commissioning, qualification, or validation within the pharmaceutical or biotechnology industry is highly desirable. Proficiency in Microsoft applications is required.
• Strong understanding of cGMP and qualification/commissioning principles.
• Familiarity with industry guidance documents and standards.
• Excellent verbal and written communication skills.
• Effective presentation, interpersonal, and time management abilities.
• Strong problem-solving and negotiation skills.
• Customer-focused with the ability to manage changing priorities and multiple tasks efficiently.
