DirecciónFor 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. Reporting to the medical device industrial Plant Manager in our Center of Excellence for surgery devices, the candidate must fulfill the following requirements: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. 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. 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. Nuestra oferta 29. 02. 2024
