CAPEX Project Engineer (Aseptic / France)
Date Posted: May 24, 2024
Job Description
We are currently seeking a highly skilled CAPEX Project and Process Engineer to join our team for a project focused on aseptic manufacturing lines in France. The ideal candidate will have extensive experience in both project management and process engineering, specifically within aseptic environments in the pharmaceutical or biotechnology industry. This role involves leading capital expenditure (CAPEX) projects and optimizing aseptic processes to ensure efficiency, quality, and regulatory compliance.
Key Responsibilities
- Lead and manage CAPEX projects for the design, development, and implementation of aseptic manufacturing lines, ensuring they are delivered on time, within scope, and within budget.
- Develop and implement process engineering solutions to optimize aseptic manufacturing processes, ensuring compliance with regulatory requirements.
- Collaborate with cross-functional teams, including Quality Assurance, Validation, and Operations, to define project and process requirements and integrate new solutions into existing manufacturing infrastructure.
- Conduct process simulations, modeling, and analysis to identify opportunities for process improvements and efficiency gains.
- Oversee the development and scale-up of aseptic processes from laboratory to production scale, ensuring robust and reproducible manufacturing processes.
- Develop and implement process validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) specific to aseptic processes.
- Provide technical leadership and troubleshooting expertise for aseptic manufacturing processes, diagnosing and resolving complex issues in a timely manner.
- Prepare and maintain comprehensive project and process documentation, including design documents, project plans, process flow diagrams, and standard operating procedures (SOPs).
- Monitor and report on project and process performance metrics, identifying trends and areas for improvement.
- Stay informed about industry trends, regulatory changes, and best practices in aseptic process engineering and project management, and propose innovative solutions to enhance operational efficiency and compliance.
- Mentor and guide junior engineers, providing technical expertise and fostering a collaborative and innovative work environment.
Required Qualifications and Skills
- Bachelor’s degree in Chemical Engineering, Process Engineering, Project Management, or a related field. Advanced degree preferred.
- Minimum of 7 years of experience in process engineering and project management within aseptic environments in the pharmaceutical or biotechnology industry.
- Strong understanding of aseptic manufacturing processes and regulatory requirements (e.g., GMP, FDA).
- Proven experience in managing CAPEX projects, including budgeting, scheduling, and resource allocation.
- Proven experience in the design, development, and validation of aseptic processes.
- Excellent problem-solving skills and the ability to work effectively in a fast-paced, team-oriented environment.
- Strong communication and interpersonal skills, with the ability to effectively interact with stakeholders at all levels of the organization.
- Proficiency in project management and process simulation software and tools.
- Proven track record of successful project delivery and adherence to project timelines and budgets.
If you are keen to grow your career with this job, apply with us and send us your resume now. All shortlisted candidates will be contacted shortly.
Reference no.: 122-4948-2918-NW
Registration no.: 968446516E
