Aseptic Filling Production Line Manager

hace 2 días


Barcelona, España MCR International A tiempo completo

Descripción del Trabajo / Job Description
- LF-2402-43
ASEPTIC FILLING PRODUCTION LINE MANAGER
BARCELONA
For our new aseptic production line in Rubí, Barcelona, we actively seek for a senior aseptic filling production line manager, with full accountability on the production, maintenance and quality assurance processes.
Yours Responsabilities
- Proven knowledge of aseptic filling techniques and cleanroom protocols in similar roles in the pharma or Medtech industry.
- Proficiency in aseptic technique training and supervision.
- Solid understanding of microbiology principles and microbial testing methods.
- Strong expertise with validation and qualification processes for aseptic manufacturing.
- Expertise in aseptic process simulations and media fills.
- Competence in following Standard Operating Procedures (SOPs) and protocols.
- Understanding of environmental monitoring and control in sterile environments.
- Knowledge of GMP (Good Manufacturing Practices) and FDA regulations.
- Understanding of risk assessment and mitigation strategies in aseptic environments.
- Experience with aseptic gowning procedures and Personal Protective Equipment (PPE) usage.
- Proven record of production teams leadership and goal achievement (Productivity, Shopfloor management KPIs ).
- Experience in LEAN methodologies and Operational Excellence.
- Proficient in Spanish language.
- Intermediate English level mandatory.
- Professional Competency
- Master’s/bachelor’s degree in pharmacy, Biology or Chemistry preferred.
- Previous assignments dealing with synthetic or natural origin surgical glues manufacturing.
- At least 5 years of experience in aseptic filling in single device delivery device and packaging processes.
- At least 5 years of experience in operating and maintaining laboratory equipment, such as autoclaves, incubators, and laminar flow hoods.
- Knowledge of sterile product formulation and compounding.
- Familiarity with sterilization methods, including heat, chemical, and radiation sterilization.
- Personal Competency
- At least 2 years of demonstrated leaderchip experience for own tema and collaborators from other areas.
- Capacity for analysis and results orientation, including the management of indicator.
- Ability to establish relationship with diverse profiles.
- Commitment

Compartir Posición / Share Position

Detalles / Details
- Ciudad / City
Barcelona
País / Country
ESPAÑA


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