Responsibilities :
- Lead the commissioning and qualification activities for aseptic fill manufacturing equipment, including vial washers, depyrogenation tunnels, isolators, sterile fillers, and cappers.
- Develop and execute qualification protocols (IQ / OQ / PQ) in accordance with regulatory requirements (FDA, EMA, etc.) and company standards.
- Collaborate with cross-functional teams, including engineering, quality assurance, and production, to ensure successful equipment qualification and seamless integration into manufacturing operations.
- Conduct risk assessments and implement appropriate mitigation strategies to ensure the integrity and sterility of the manufacturing process.
- Troubleshoot equipment issues and implement corrective and preventive actions (CAPAs) as needed to maintain equipment performance and compliance.
- Provide technical expertise and support to manufacturing personnel during routine operations, ensuring adherence to standard operating procedures (SOPs) and best practices for aseptic processing.
- Stay current with industry trends, regulations, and advancements in aseptic fill manufacturing technologies, and incorporate best practices into manufacturing processes.
Requirements :
- Bachelor's degree in engineering, pharmaceutical sciences, or related field. Advanced degree preferred.
- Minimum of years of experience in aseptic fill manufacturing, with a focus on commissioning and qualification of equipment.
- Extensive knowledge of regulatory requirements and guidelines governing aseptic processing (, cGMP, Annex ).
- Proven experience in developing and executing qualification protocols (IQ / OQ / PQ) for aseptic fill manufacturing equipment.
- Strong analytical and problem-solving skills, with the ability to identify and resolve technical issues in a timely manner.
- Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.
- Detail-oriented and organized, with a commitment to quality and compliance.
- Experience with risk assessment methodologies and implementation of risk-based approaches to equipment qualification and process validation.
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