Vacature Senior Engineer C

Senior Engineer C&Q

• Titel Senior Engineer C&Q
• Functie Supply Chain Engineering
• Sub functie Project Engineering
• Locatie Leiden, South Holland, Netherlands
• Gepost jan 05 2024
• Referentie 2406160184W

Beschrijving

Janssen Biologics B.V., a member of the Johnson & Johnson Family of Companies is recruiting for a Senior Engineer MSAT to be based in Leiden, the Netherlands. Our site produces biotherapeutic drug substance and is growing our portfolio to include novel advance therapeutic medicinal products.

The Make Asset Management (MAM) team is responsible for the introduction and maintains of assets on the site. Within this organization, the C&Q team contributes by performing commissioning and qualification activities for GMP equipment, utilities and facilities. To build up and strengthen our team, we are looking for hardworking and dedicated people. This is the best moment to join us!

Function description:

As a Commissioning and Qualification (C&Q) Engineer, you will play a crucial role in ensuring the successful implementation and validation of manufacturing systems and equipment. Your primary responsibilities will involve overseeing commissioning and qualification activities and contributing to the continuous improvement of validation processes to ensure compliance with regulatory standards and industry best practices.

Responsibilities & Accountabilities:

• System Commissioning: Lead the commissioning process for new or upgraded systems, ensuring proper installation and functionality.
• Qualification Planning: Develop qualification plans based on project requirements, regulatory guidelines, and company standards.
• Execution of Qualification Protocols: Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols in collaboration with cross-functional teams.
• Risk Assessment: Conduct risk assessments related to the commissioning and qualification activities, identifying and mitigating potential risks.
• Documentation and Compliance: Generate and maintain comprehensive documentation, including test scripts, reports, and validation protocols, ensuring compliance with regulatory requirements.
• Change Control Management: Participate in change control processes, assessing the impact of changes on validated systems and implementing necessary validations.
• Collaboration: Collaborate with engineering, quality assurance, and production teams to ensure flawless integration of new systems and modifications.
• Troubleshooting and Issue Resolution: Identify and resolve issues related to equipment, systems, or processes during the commissioning and qualification phases.
• Training: Provide training to relevant personnel on validated systems and associated processes.
• Continuous Improvement: Contribute to continuous improvement initiatives by recommending enhancements to commissioning and qualification processes.

Kwalificaties

• Bachelor's or master's degree in engineering or a related field or equivalent through experience.
• Minimum 4 years of relevant experience in the (bio)pharmaceutical industry or related academic experience or education is required.
• Familiar with regulations (ICH, EMA, CFR) and industry standard (ISPE, PDA)
• Accurate, structured, flexible and customer focused;
• Good communication skills in English (both oral and written);
• Experience with cGMP inspections, process excellence and project management is an advantage.

Heb je interesse in deze vacature en wil je graag op deze functie solliciteren? Neem dan contact op met Johnson & Johnson via onbekend of onbekend. Of bezoek hun website onbekend.