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Manufacturing Process Specialist
3 weeks ago
About the Position:
This is a critical role ensuring that all equipment, facilities, utilities, and manufacturing processes meet stringent engineering and regulatory standards.
Key Responsibilities:
- Plan, execute, and document validation and qualification activities for equipment, facilities, utilities, and manufacturing processes.
- Ensure systems are designed, installed, and operated in line with engineering specifications and regulatory requirements.
- Act as site expert for lyophilization and related sterile manufacturing processes.
- Maintain regulatory compliance while driving continuous improvement in product quality and manufacturing efficiency.
- Support high-priority development and commercial projects through technical problem-solving and validation expertise.
- Collaborate across departments to ensure site readiness for inspections and audits.
Requirements:
- Degree in Engineering, Pharmaceutical Sciences, or a related discipline.
- Demonstrated experience in validation engineering within a pharmaceutical GMP environment.
- Strong knowledge of validation principles, regulatory requirements, and industry standards.
- Hands-on expertise with sterile manufacturing processes and lyophilization preferred.
- Proven ability to manage multiple projects with strong attention to detail and documentation practices.
- Excellent problem-solving skills and ability to work effectively within cross-functional teams.
- Must have full working rights within Australia.
