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Process Engineer
2 mesi fa
We are seeking a highly skilled Process Engineer to join our team at CAI, where you will play a key role in driving the success of our Life Sciences business in South Europe. As a Process Engineer, you will be responsible for leading Technology Transfer projects, ensuring seamless execution and compliance with regulatory requirements.
Key Responsibilities:- Technology Transfer: Lead Technology Transfer projects, leveraging your expertise in Process Manufacturing Science and Technology to ensure successful project execution.
- Project Management: Manage projects from initiation to closure, ensuring timely delivery and adherence to quality standards.
- Cleaning Validation: Develop and implement Cleaning Validation strategies to ensure compliance with regulatory requirements.
- Change Control: Develop and implement Change Control procedures to ensure seamless execution of changes.
- CAPA Process: Develop and implement CAPA processes to identify and correct deviations.
- Commissioning and Qualification: Lead Commissioning and Qualification activities to ensure equipment and systems are properly installed and validated.
- User Requirements: Develop and implement User Requirements to ensure equipment and systems meet user needs.
- Schedule Development and Execution: Develop and execute project schedules to ensure timely delivery.
- Metrics and Performance Goals: Establish metrics and lead teams to achieve performance goals.
Requirements:
- At least 4/5 years of experience in Technology Transfer as a Process Technology SME or Process Validation SME.
- Experience in project management in Technology Transfer projects or similar contexts.
- Management or involvement in an average number of Technology Transfer projects (not less than 5).
- Experience in manufacturing of complex pharmaceutical forms, such as aseptic processes, lyophilized products, biological products, and biotechnology/biosimilar products.
Desired Experience:
- Developing Validation/Verification Master Plans.
- Performing formal risk assessments/FMEA.
- Change Control.
- CAPA process.
- Identifying Critical Attributes and Critical Process Parameters.
- Commissioning and Qualification.
- Developing User Requirements.
- Schedule development and execution.
- Establishing metrics and leading team to achieve performance goals.
Language: English (en-US)
