QC Engineer Environmental Monitoring Systems (12 months Contract) fixed-term

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

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EMS Expert – Environmental Monitoring Systems

QC Engineer Environmental Monitoring Systems

Description

The EMS (Environmental Monitoring Systems) group is responsible for monitoring and managing quality aspects for utilities and the environment in classified clean rooms. Additionally, it act as the owner of the gowning and disinfection processes in these controlled areas. This includes the following areas:

• Pharmaceutical production departments: Sterile forms, Liquids and Semi-solid forms, Central Weighing Department, Transdermal forms, Oils and warehouses (Goods Received/Out & distribution), & Chemical production.
• QC Laboratory Microbiology
• Pharmaceutical Product Development

Your Role

• You are responsible for the gowning and disinfection processes of the various departments and lead projects for optimization.
• You participate as a subject matter expert in cross-departmental projects and advise on possible quality and compliance impacts.
• You actively seek opportunities to improve the quality level and efficiency of EMS processes.
• You have a strong quality awareness and act in accordance with (inter)national cGMP guidelines.
• You maintain good relationships with various stakeholders (including quality assurance, production, facilities & utilities, technical services, etc.), the laboratory, and suppliers.
• You always prioritize safety.

Your Profile

• You hold a master's degree with a microbiological, biotechnological, (bio)chemical, or pharmaceutical background, or equivalent experience.
• Knowledge of microbiology, experience in a pharmaceutical production environment, and experience within a pharmaceutical quality organization are a plus.
• Knowledge of regulations and cGMP (FDA, EU, ISO, etc.) is a plus.
• You are quality-conscious and have a strong sense of responsibility.
• You can work both independently and as part of a team.
• You are resilient to stress.
• You are driven to achieve results in a qualitative and safe manner.
• You are communicative, flexible, and adequately assertive.
• You gain energy from collaborating and achieving results within a multidisciplinary team.
• You have a good knowledge of Dutch and English.