Jobid=846c766fa587 (0.0565)
Delpharm Development Leiden is looking for a Sr. Utilities Engineer
Let’s Develop Our Future Together!
We are looking for a Sr. Utilities Engineer to join our team!
The Senior Utilities Engineer plays a pivotal role in the successful startup, operation, and compliance of clean utility systems (WFI, PW, Clean Steam, HVAC, compressed gases) within a sterile pharmaceutical GMP environment. The Engineer ensures design, qualification, commissioning and regulatory compliance in alignment with industry standards and regulatory bodies such as IGJ, FDA, and EMA.
Your responsibilities:
Your responsibilities will include the hands-on execution and oversight of commissioning activities and qualification phases (IQ, OQ, PQ) for clean utility systems, in line with ASTM E2500 and GAMP principles.
You will lead Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT), as well as the development of User Requirements Specifications (URS), Functional Specifications (FS), and Detailed Design Specifications (DDS).
In addition, you will be responsible for the timely maintenance of utilities, coordinating with third parties and vendors to ensure that all utilities remain operational and maintain their validated status.
Responsible to bring and keeping WFI, Purified Water, Gases and Clean Steam systems online within GMP conditions.
Also:
- Engage early in project lifecycle from design review of P&IDs, layouts, and isometric drawings through final system handover.
- Critically evaluate design documentation to assure compliance and operational reliability.
- Support and prepare for pharmaceutical inspections from IGJ
- Provide detailed knowledge of regulatory expectations related to design, qualification, and operational aspects of utilities.
- Lead or assist investigations related to system excursions and CAPA implementation during inspections.
- Design sampling and testing strategies, including location selection and sampling frequency for PW, WFI, and Clean Steam during startup, validation, and routine operation.
- Define alert and action limits and lead investigations of excursions to ensure continuous compliance with GMP standards.
- Develop a maintenance strategy, robust SOPs, maintenance plans,
- Ensure the technical documentation for utilities is complete and controlled
- Drive process improvements focusing on system reliability, compliance, energy efficiency, and sustainability.
We are looking for a Sr. Utilities Engineer with the following profile
- 5-10+ years in pharmaceutical or biotech GMP environment.
- Direct experience in bringing WFI/PW/clean steam systems online in a startup setting.
- Knowledgeable in design, qualification, and regulatory expectations of clean utilities.
- Experience supporting IGJ or other regulatory inspections related to utility systems.
We offer you
- A great place to work within a team of motivated specialist
- Learning and development opportunities
- Market conform salary based on experience and seniority €5000- €7000
- Variable pay bonus
- 25 holidays + 6 Delpharm designated days
- Pension scheme including personal options such as partner pension, ANW shortfall and extra savings
- NS business card or Travel allowance
- Laptop and company phone
Our organization
Delpharm Leiden is a dedicated development center within the Delpharm network, focusing on injectable dosage forms. Connecting our team of experts with advanced equipment, like our recently acquired HRMS, we position ourselves as specialists in our field. Providing a comprehensive range of services from research & development to clinical phase. Our team, capable of handing potent compounds, sets high standards when it comes to safety, quality and employee well-being. Driven by the aspiration to continuously enhance our services, we apply methodologies such as Quality by Design (QbD), data science and lean principles. These practices not only contribute to the refinement of our internal processes but also enable us to meet the evolving needs of our customers with the end goal in mind: impacting the patients life.
Furthermore, joining Delpharm Leiden means becoming a member of an international and diverse organization. We have a close team fostering lasting connections, where many individuals have dedicated 10 years or more to our collective success. Together with our active Staff Association we arrange several social activities a year and share work, hobbies and personal experiences in our frequent get togethers and our staff magazine. These and many other initiatives allow us to create a rich and supportive community within our workplace.
Want to join Delpharm Development Leiden?
Apply via: https://jobs.jobvite.com/delpharm-leiden/jobs
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Please note that we prioritize local hiring and, as required by Dutch law, will be conducting an initial search within the local talent pool. Therefore, we kindly request that only applicants residing locally apply at this stage. Applications from candidates residing abroad will not be processed during this phase. Thank you for your understanding
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