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Project Qualification and Commissioning Engineer

3-5 Years
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  • Posted 22 days ago
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Job Description

We are seeking a Project Qualification and Commissioning Engineer to manage the execution of test protocols and ensure the successful deployment of integrated solutions. The ideal candidate will be responsible for customer interactions, overseeing PRE-FAT, FAT, and SAT procedures, and guaranteeing compliance with all test specifications. This role requires an individual who is highly skilled in testing and troubleshooting, methodical in their approach, and willing to travel extensively to various project sites.

Responsibilities

  • Execute PRE-FAT, FAT, and SAT procedures as per established test protocols.
  • Interact directly with customers, ensuring compliance with test specifications and securing all necessary documentation and approvals.
  • Utilize strong testing and troubleshooting skills for systems, including those comprising SCADA.
  • Monitor and address NCRs (Non-Conformance Reports) raised during the PRE-FAT, FAT, and SAT stages.
  • Demonstrate strong problem-solving abilities and effectively coordinate with cross-functional teams.
  • Establish and maintain positive working relationships with all internal and external interfaces.

Qualifications

  • Bachelor's degree in a relevant science, engineering, or a related subject.
  • Prior experience in the qualification and commissioning of bio-pharmaceutical equipment.
  • Knowledge of current regulatory requirements, such as GMP, GEP, GAMP, and ISPE standards.
  • Good technical and process engineering knowledge, including the ability to understand drawings and standards.

Skills

  • Strong interpersonal and excellent written and verbal communication skills.
  • Well-organized and methodical, with a keen attention to detail.
  • Ability to develop realistic work plans and set personal goals that align with company objectives.
  • The ability to prioritize and manage daily assignments effectively.
  • Willingness to travel extensively.

More Info

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About Company

Sartorius is a leading international partner of life sciences research and biopharmaceutical manufacturing. We help our customers simplify progress from drug discovery to manufacturing so that more people can have access to better medicine. With this, we are part of the solution in the fight against diseases worldwide. With innovative laboratory instruments and consumables, the Lab Products & Services division focuses on laboratories performing research and quality control at pharmaceutical and biopharmaceutical companies as well as academic research institutes. The Bioprocess Solutions division, with its broad product portfolio focusing on single-use solutions, helps customers manufacture biotech medications, vaccines, and cell and gene therapies safely, rapidly, and economically. Based in Göttingen, Germany, Sartorius also has a strong global reach with more than 60 production and sales sites worldwide. We regularly expand our portfolio through the acquisition of complementary technologies. In 2024, Sartorius generated sales revenue of around 3.4 billion euros. Currently, more than 13,500 employees from around 110 nations are working for customers around the globe. Join our team, partner or collaborate with us.

Job ID: 123206347