Project & Process Manager (m/w/d)
Our customer is an independent international aesthetics and neurotoxin company with its own research and development activities. Headquartered in Frankfurt, Germany, the family-owned firm with a 100 year-plus history has a direct presence in 28 countries with approximately 3,000 employees worldwide. Due to continous growth we are looking to fill the position of Project & Process Manager at the Dessau site (m/w/d).
Responsible to support new product introduction by developing new processes and evaluating existing processes to improve it, reduce cost and develop best practices. Develop and implement innovative solutions while maintaining reliable, safe, high-quality of products. Develop a culture of continuous improvement by innovative solutions.
As part of the matrix organization, participate transversally in the projects of the company or the group, either directly or by making employees under its responsibility available.
Key Activities & Accountabilities:
Prohect and Process Improvement Manager will be responsible for (but not limited to):
- Provide technical leadership to identify, evaluate, improve and design process development strategies.
- Collaborate for an effective development activity with Quality, R&D, Analytic, Validation group, Support, Engineering Facilities and various vendors to develop and sustain processes for new products.
- Evaluate in collaboration with Manufacturing and Engineering groups if new or improved processes are compatible with our manufacturing facilities and equipment, and will work with the Quality group and Regulatory Affairs to ensure the processes are appropriately developed and validated for a GMP environment.
- Assure process development project tasks are accomplished within defined timelines, procedures, objectives, budget and required safety/compliance standards
- Provide support to new product introduction, production process development, product transfers, and existing process sustainment
- Manage the project development team, including hiring, performance management, training and professional development.
- Manage the design and execution of process development (Preparation, Synthesis, Dialysis, degassing filling, sterilization, final packaging) and appropriate verification/validation activities accordingly applicable procedures and regulations.
- Develop and/or review/approve documentation to support new and improved manufacturing processes per applicable procedures.
- Maintain complete and thorough documentation in accordance with required US and international standards (e.g., ISO compliance, GLP/GMP/QSR requirements, etc.) for assigned projects.
- Write and perform Validation plan strategy and process validations in collaboration with Validation team including methods for inspection.
- Manage and control Risk process analysis and appropriate recommendations to mitigate the risk.
- Manages Process Development team and provides technical support and guidance to help maintain project timelines while assuring compliance to all regulatory requirements.
- Maintain regular communication channel on project activities (internally /externally) by project update /KPIs/ project minutes.
- Work on teams to develop and transfer new processes/products to production and enhance their robustness.
- Direct contact with R&D and Manufacturing to understand new requirements for manufacturing processes.
- Assess process capabilities, prioritize process improvement opportunities, and innovate and implement process improvements on commercial products.(PQR / annual review)
- Work cross functionally with R&D, Manufacturing and Quality to optimize processes, address yield and quality issues and drive implementation of solutions in a production environment to meet production goals (CAPA/ MRB/ DCC meetings)
Qualifications & Experience
- With an engineer background in technical operations, successful experience in managing a manu-facturing unit, ideally in the medical device field or pharmaceutical clean room environment
- Engineering degree or equivalent, with several years confirmed experience in product/process development activities and project management in a regulated field.
- Relevant experience in production support/sustaining and/or process definition and development, design, improvement and validation
- Industrial experience working in a GMP’s compliant setting
- Experience leading cross-functional teams in the development and scale up of manufacturing processes,
- Experience with regulatory filings for Medical Devices and supporting regulatory inspections ISO 13485 - FDA 21 CFR 820 - MDSAP
- Project management in international environment focused on results
- Experience on statistic and SPC (Minitab)
- German and English speaking, French is bonus
Are you interested in this challanging position? Then please contact us and send your CV to:
Dr. Andrea Sandmöller
firstname.lastname@example.org, Tel. +49 (0)172 3546586
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