Senior Manufacturing Science, and Technology (MSAT) Engineer / Scientist

  Do you want to take responsibility and make a difference with your work? With your expertise, we can achieve great goals together. We are WACKER - Reliable. Determined. Ambitious. As one of the world's most research-intensive chemical companies, we've been making countless products that are an integral part of your everyday life possible for over 100 years. From vegan food to resource-efficient buildings to solar cells, we develop sustainable solutions that change the future.   To strengthen our team in San Diego, we are looking for you as a(n) Senior Manufacturing Science, and Technology (MSAT) Engineer / Scientist.

 

This position will be reporting to Manufacturing, Science, and Technology (MSAT) manager. The experienced-Level MSAT Engineer / Scientist will be responsible for supporting manufacturing operations in all aspects of plasmid DNA manufacturing, including fermentation, centrifugation, lysis, and chromatographic processes and by applying engineering knowledge to troubleshoot problems and improve production capabilities.  The Senior MSAT Engineer / Scientist would be responsible for acquiring knowledge on pDNA, mRNA, protein, and other new biotechnology platforms to expand Wacker's service offerings.

 

The position entails Manufacturing Science and Technology (MSAT) responsibilities that include product and equipment technology transfer.  The position will provide relevant input to the project core-team(s).   The position ensures successful technology transfer from development (or small-scale process) to a larger production scale by being the production representative of an assigned operation step.

 

The Senior MSAT Engineer / Scientist maybe be responsible for more than one unit operation based on the number of years they have been in the industry and acquired bioprocessing knowledge.  They will be responsible for providing training to operators upon complete the tech transfer process and perform the duties within the boundaries of EH&S and cGMP requirements, as well as client´s expectations.  The Senior MSAT Engineer / Scientist will lead projects and activities independent to ensure equipment and process are designed and procured to meet project timelines.  This position will provide cross training to other engineers.

 

The Senior MSAT Engineer / Scientist is also responsible to ensure life-cycle management of a process from transfer, via process validation to continuous process verification.  In addition, ensuring process related support to shopfloor for routine processes when needed.

 

Wacker is a safety-first culture, the Senior MSAT Engineer / Scientist will be responsible in maintaining a safe work environment, following all safety rules and wearing appropriate PPE when needed. Identifying any potential safety issues and reporting such issues and assist in rectifying, if applicable.

 

Essential Functions of the Position:

• Act on the interface between development and production especially with respect to technology transfer.
• Participate in boards and project core-teams, and act as focal point for other departments (representative of production). The position requires the individual to be the subject matter expert (SME) of their assigned process and provide relevant input to the tech transfer project.  The position is responsible for successfully scaling up and introducing a new process into the GMP manufacturing facility.
• Accurate assessment of the status of a project when GMP-introduction is proposed, including keeping, together with the rest of the project core-team, the risk assessment (a living document) of the project up to date.
• Ensure, for validated processes, that the relevant continuous verification program is in place, executed and reviewed.
• Ensure process batch records, operating procedures and processes are cGMP compliant and receiving input from the relevant departments and groups (engineering, technical and quality group, manufacturing) to ensure the same for equipment.
• Execute processes and record, calculate, control and review MSAT data and GMP production data in a manner that is accurate, timely, complete, factual, and clear.
• Perform post campaign process evaluation leading to either generate Technical Report or intermittent recom