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Manufacturing Project Leads

Hillerød, Denmark

We are looking for two Manufacturing Project Leads to join the Drug Substance Manufacturing Project & Support team. You will be part of a team of 9 dedicated employees who execute Opex projects and deliver general support to the Drug Substance Manufacturing organisation (DSM).

The role

In the role as Manufacturing Project Lead you are responsible for executing various Opex tasks in different departments, supporting the following; MES systems, deviation handling, procedure updates and failure investigation in close collaboration with QA functions other departments.

Delivering support to manufacturing covers ongoing support to MES systems, manufacturing optimization tasks and executing Opex projects. Opex projects comprises replacement, change or introduction of new DSM equipment. This is followed by thorough technical review and assessment of equipment impact on manufacturing processes and change control procedures.

Main responsibilities:

  • Execute Opex projects in different departments across DSM
  • Troubleshooting of challenges in MES systems together with IT/Automation.
  • Defining tasks and projects through URS description or similar with DSM departments.
  • Support with technical knowledge for updating and changes of general documents in DSM
  • Perform EHS tasks, CAPA work and review of validation protocols.
  • Introduction of new manufacturing equipment, items and procedures in DSM.
  • Planning and supporting change control.
  • Ongoing support and participation in Site Capex projects.

Qualifications and Education

  • You have a Bachelor or Master Degree within Engineering, Pharmacy or similar and a minimum of severa years relevant working experience in a cGMP environment e.g. biotech, pharmaceutical industry.
  • You are an experienced Engineer or similar with analytical skills and project supporter mindset. You have a successful track record in delivering Opex task in a manufacturing environment. You are used to work closely with manufacturing MES systems and GMP IT systems.
  • In delivering your work and results you have gained experience and knowledge of databases, tools and systems (MS Project, Excel etc.) and solid experience in the execution of projects.
  • Thorough understanding and ability to execute against regulatory compliance parameters and solid and in-depth experience with GMP.
  • Excellent English skills verbally and in writing and excellent oral and written communication skills, as you must be able to work cross-functional with multiple stakeholders.
  • As a person you have a strong sense of urgency about solving problems, prioritizing and getting work done. You have good energy, you are proactive and you enjoy working in a dynamic and innovative environment with changing priorities.

For more questions about the position, please contact William Herrmans, Project Manager Mfg Support on 81929161.

Application

Please upload your CV and cover letter as soon as possible. We are reviewing applications on a continuous basis and urge you to apply as soon as possible, however delays in response time should be expected as we enter the vacation period.

 


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