Work instruction translator

Department:

The Bioprocessing Department of Operations is responsible for the quality and safety of processes and the equipment used by the Fermentation, Pre-culture, Bioreactor Assembly, Primary Recovery, Downstream Processing and Column Packing departments.

In addition, the department is responsible for investigating and immediately solving (technical and quality-related) deviations in the production process, including support in outside office hours as part of on-call duty.

The department leads and participates in various projects to optimize and implement new equipment and processes.
Job Description:

As a Manufacturing Process Specialist/ Equipment Engineer, you are responsible for the availability and functionality of the equipment required for the production purposes.

This includes:


* Work with cross functional team members, incorporating external manufacturing partners to ensure equipment meets varied quality, EHSS and compliance requirements


* Initiate and lead process and/or equipment improvement projects.

This includes leading and executing Change Control processes, managing Business Improvements and defining User Requirements in consultation with a multidisciplinary team.

Ensure that value-added improvements in the areas of capacity, safety (EHS&S) and quality (GMP) regarding equipment and/or process are implemented


* Participate in NPI projects and (global) multidisciplinary projects as an extended team member.


* Develop and sustain a long-term strategy for the asset such that manufacturing capacity remains adequate.

Ensure that an Asset Team is in place to ensure life cycle management of the equipment.


* Actively lead and/or participates in investigations into deviations in production processes, identifies corrective and/or preventive actions and ensures that these are dealt with adequately and within agreed timelines.

Provide first line support to manufacturing by, for example, providing expert advice to the shop floor in case of process issues.

Take part of on-call duty for troubleshooting of process disturbances in collaboration with team of Business System Owners.

Are you a hardworking team player, with a 'can-do' mentality and a good eye for technical challenges? Then we are looking for you!Qualifications:


* Higher professional education (HBO) or university education (WO) education, in a relevant field (e.g.

pharmaceutical sciences, biotechnology, biochemistry, life sciences, biological engineering, etc).


* 4-2 years' experience in a biotechnology or biopharmaceutical industry environment.


* Experience with downstream production processes and equipment.

Preferably experience with/knowledge of both upstream and downstream processing.


* Affinity for production equipment and automation systems (e.g.

DeltaV).


* Able to work in a high quality environment (GMP)


* Can work well both independently and in a team.


* Good Data Analysis skills


* Good organizational chan...