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.