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Jobdetails

Zusammenfassung

  • Basel, Basel-Stadt
  • Temporär

veröffentlicht am 18. mai 2026

Referenznummer
25158
nimm Kontakt mit uns auf

Wir sind hier, um dir bei deinen Fragen zu helfen.

W

Walentyna Dobrowolska

+41 58 201 56 71

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randstad professional

randstad professional

We bring diverse and pre qualified professional talent and businesses together to connect the right people with the right roles. By building specialized teams, we help individuals flourish in their careers and businesses succeed.

Jobdetails

For one of our clients, a global pioneer in pharmaceuticals, we are currently looking for a Process Engineer (Downstream).

General Information:

  • Start Date: 01.07.2026
  • Latest possible start date: 01.08.2026
  • Planned Employment Duration: 12 months
  • Workplace: Basel
  • Home Office: possible upon agreement, onsite presence required
  • Workload: 100%
  • Team: 15–25 team members
  • Department: Drug Substance Internal and External Manufacturing (MMN)
  • Working Hours: Standard

About the job:

As a Process Engineer Downstream, you will provide solutions in the B91 Manufacturing Unit SUT (Single-Use Technology) at Basel Drug Substance Manufacturing to ensure safe and high-quality antibody production. You will be developing and implementing process improvements and by fostering dialogue and collaboration between local and global functions in the areas of Development, Innovation, and Regulatory. Within our RePeng team (Recipe and Process Engineering), we are looking for you as a Process Engineer to optimize our downstream processes.

The perfect candidate

Holds a university degree, has at least 3 years of professional experience, and possesses extensive knowledge in downstream processing and/or upstream processing of biotechnologically manufactured products. Furthermore, a minimum of 2 years of experience in biopharmaceutical manufacturing or development is required, along with experience working in a cGMP environment.

Tasks & Responsibilities:

  • Provide technical and scientific support to the shifts to ensure robust and efficient manufacturing processes in a GMP environment, including readiness for on-call duty.
  • Plan and coordinate troubleshooting activities and root-cause analyses in close cooperation with other Manufacturing Units, Quality, MSAT, and other departments.
  • Handle planned and unplanned events in accordance with GMP guidelines.
  • Review and approve electronic batch records for commercial and clinical products (MES-based batch record review).
  • Act in accordance with the requirements of the internal Pharmaceutical Quality System (PQS) and the cGMP regulations of health authorities.
  • Lead or support optimization projects and the introduction of new technologies or products.
  • Plan, prepare, moderate, execute, summarize, review, and update new and existing Quality Risk Assessments within the framework of commercial manufacturing to ensure systematic identification and reduction/elimination of GMP compliance risks.
  • Act as Owner of the production processes (interfacing between Manufacturing, Science, and Technology).
  • Author and present concepts, documents, and assessments during GMP audits and health authority inspections.
  • Represent the site in network initiatives and network communities.

Must-Haves:

  • Completed degree in Natural Sciences or Engineering; a degree in Biotechnology or Bioprocess Engineering is preferred.
  • Min. 3–5 years of experience and extensive knowledge in the field of Downstream Processing.
  • Min. 2 years of experience in biopharmaceutical manufacturing or development.
  • Experience working in a cGMP environment.
  • Hands-on experience in large molecule drug substance manufacturing processes in stainless steel or single-use technology is an advantage.
  • Experience with technology transfers and Quality Risk Management (QRM) is an advantage.
  • Team player with a very high degree of autonomy in a self-directed environment.
  • Excellent communication skills when interacting with the team, as well as local and global interfaces.
  • Enjoyment of working in global teams.
  • The local working language is German, therefore very good spoken and written German skills are required.
  • Excellent command of both German and English (written and spoken).

Sounds interesting? Apply now – we’re looking forward to receiving your applications!

Application Submission Deadline: 26.05.2026

...

For one of our clients, a global pioneer in pharmaceuticals, we are currently looking for a Process Engineer (Downstream).

General Information:

  • Start Date: 01.07.2026
  • Latest possible start date: 01.08.2026
  • Planned Employment Duration: 12 months
  • Workplace: Basel
  • Home Office: possible upon agreement, onsite presence required
  • Workload: 100%
  • Team: 15–25 team members
  • Department: Drug Substance Internal and External Manufacturing (MMN)
  • Working Hours: Standard

About the job:

As a Process Engineer Downstream, you will provide solutions in the B91 Manufacturing Unit SUT (Single-Use Technology) at Basel Drug Substance Manufacturing to ensure safe and high-quality antibody production. You will be developing and implementing process improvements and by fostering dialogue and collaboration between local and global functions in the areas of Development, Innovation, and Regulatory. Within our RePeng team (Recipe and Process Engineering), we are looking for you as a Process Engineer to optimize our downstream processes.

The perfect candidate

Holds a university degree, has at least 3 years of professional experience, and possesses extensive knowledge in downstream processing and/or upstream processing of biotechnologically manufactured products. Furthermore, a minimum of 2 years of experience in biopharmaceutical manufacturing or development is required, along with experience working in a cGMP environment.

Tasks & Responsibilities:

  • Provide technical and scientific support to the shifts to ensure robust and efficient manufacturing processes in a GMP environment, including readiness for on-call duty.
  • Plan and coordinate troubleshooting activities and root-cause analyses in close cooperation with other Manufacturing Units, Quality, MSAT, and other departments.
  • Handle planned and unplanned events in accordance with GMP guidelines.
  • Review and approve electronic batch records for commercial and clinical products (MES-based batch record review).
  • Act in accordance with the requirements of the internal Pharmaceutical Quality System (PQS) and the cGMP regulations of health authorities.
  • Lead or support optimization projects and the introduction of new technologies or products.
  • Plan, prepare, moderate, execute, summarize, review, and update new and existing Quality Risk Assessments within the framework of commercial manufacturing to ensure systematic identification and reduction/elimination of GMP compliance risks.
  • Act as Owner of the production processes (interfacing between Manufacturing, Science, and Technology).
  • Author and present concepts, documents, and assessments during GMP audits and health authority inspections.
  • Represent the site in network initiatives and network communities.

Must-Haves:

  • Completed degree in Natural Sciences or Engineering; a degree in Biotechnology or Bioprocess Engineering is preferred.
  • Min. 3–5 years of experience and extensive knowledge in the field of Downstream Processing.
  • Min. 2 years of experience in biopharmaceutical manufacturing or development.
  • Experience working in a cGMP environment.
  • Hands-on experience in large molecule drug substance manufacturing processes in stainless steel or single-use technology is an advantage.
  • Experience with technology transfers and Quality Risk Management (QRM) is an advantage.
  • Team player with a very high degree of autonomy in a self-directed environment.
  • Excellent communication skills when interacting with the team, as well as local and global interfaces.
  • Enjoyment of working in global teams.
  • The local working language is German, therefore very good spoken and written German skills are required.
  • Excellent command of both German and English (written and spoken).

Sounds interesting? Apply now – we’re looking forward to receiving your applications!

Application Submission Deadline: 26.05.2026

    nimm Kontakt mit uns auf

    Wir sind hier, um dir bei deinen Fragen zu helfen.

    W

    Walentyna Dobrowolska

    +41 58 201 56 71
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      <p>For one of our clients, a global pioneer in pharmaceuticals, we are currently looking for a Validation Manager / Engineer for Cleaning and Sterilization Validation.</p><p>General Information:</p><ul><li>Start Date: 01.07.2026</li><li>Latest possible start date: 01.09.2026</li><li>Planned Employment Duration: 9 months with the possibility of extension</li><li>Workplace: Basel</li><li>Home Office: possible, 25 %</li><li>Workload: 80-100%</li><li>Team: Org-Team: 7 people, Project Team: > 20 people</li><li>Department: Cleaning and Sterilization Validation (MMNGF)</li><li>Working Hours: Standard</li></ul><p>About the job:</p><p>Basel Drug Substance Manufacturing produces biotechnological "Large Molecule" APIs (Active Pharmaceutical Ingredients) on different scales across two production buildings for both commercial and clinical supply.</p><p>The ideal candidate</p><p>Stands out as a flexible team player with a high sense of responsibility and a willingness to take ownership, and brings relevant experience in the validation field. Prerequisites include more than 5 years of professional experience in the pharmaceutical industry within a production, development, or quality function, as well as over 3 years of experience in qualification and validation—specifically in sterilization and cleaning validation, and equipment qualification. Furthermore, strong verbal and written communication skills in both German and English are essential. Additional qualities include a friendly demeanor, good communication skills, a deep understanding of GMP, quality awareness, and technical/scientific know-how regarding cleaning and sterilization processes, including autoclaves.</p><p>Tasks & Responsibilities:</p><p>As a Validation Manager in the MSAT Cleaning & Sterilization Validation team, you will be responsible for the following tasks:</p><ul><li>Creation of qualification and validation documents in the area of cleaning and sterilization validation (plans, reports).</li><li>Accompanying/supporting validation activities, particularly coordination within the interdisciplinary team and communication with stakeholders.</li><li>Verification of equipment and ensuring release for production.</li><li>Handling ownership / acting as author for Changes, Deviations, and CAPAs, as well as writing technical assessments for stakeholders.</li><li>Support for regulatory documents / reporting procedures.</li><li>Collaboration with partners from Site Engineering, Manufacturing Plants, and QA/QC departments.</li><li>Working in an environment with strong team spirit, timely and effective communication, a sense of urgency, and high motivation to achieve operational goals.</li><li>Representing qualification and validation topics during health authority inspections.</li></ul><p>Must Haves:</p><ul><li>Bachelor’s, Master’s, or equivalent advanced degree in Natural Sciences, Engineering, Biotechnology, or a similar discipline.</li><li>Min. 5 years of professional experience in the pharmaceutical industry in a production, development, or quality function.</li><li>Min. 3 years of experience in qualification and validation, specifically sterilization and cleaning validation, and equipment qualification.</li><li>You inspire others through your structured, solution-oriented, and independent way of working, as well as your analytical thinking.</li><li>You are a quick learner, look forward to working in a team, and bring commitment and initiative.</li><li>You possess strong verbal and written communication skills in both German and English.</li><li>You have a confident, high-integrity, and competent demeanor, with the ability to influence at all levels.</li><li>You take ownership and responsibility within your own area of accountability.</li></ul><p>Nice to Haves:</p><ul><li>Experience with autoclaves / steam sterilizers.</li><li>Knowledge of IT systems (e.g., Veeva, eVAL).</li></ul><p>Sounds interesting? Apply now – we’re looking forward to receiving your applications!</p><p>Application Submission Deadline: 26.05.2026</p>
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