Senior Engineer MSAT Biotherapeutics Drug Product Cleaning Validation

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Supply Chain Engineering

Job Sub Function:
Process Engineering

Job Category:
Scientific/Technology

All Job Posting Locations:
Schaffhausen, Switzerland

Job Description:

Join us in creating a future where diseases are no longer a concern! Johnson & Johnson Innovative Medicine in Schaffhausen (Cilag AG) specializes in the production of pharmaceuticals and active ingredients.

The Schaffhausen site plays a strategic role in launching and growing some of Johnson & Johnson's key pharmaceutical products.

Utilizing advanced technologies and processes, this site manufactures a variety of pharmaceutical dosage forms and chemical active ingredients.

We are currently looking for a Senior/Staff Cleaning Validation Engineer in MSAT (Manufacturing, Science & Technology) Biotherapeutics to enhance our team.

POSITION SUMMARY:

As an MSAT Senior/Staff Validation Engineer, you will be responsible, alongside other team members, for developing, maintaining, and preparing reliable cleaning processes for product- and indirect-product contact parts to meet future requirements.

This involves collaborating in cross-functional teams within the site and exchanging knowledge with other locations worldwide.

KEY RESPONSIBILITIES:


* Develop and validate cleaning processes for new products.


* Develop and validate improved cleaning processes for existing products.


* Develop and implement new strategies for cleaning validation.


* Propose and support technical improvements to cleaning systems (CIP/COP).


* Create documents for cleaning validation activities (protocols, reports, risk assessments, SOPs).


* Coordinate cleaning validation activities with other departments.


* Calculate permissible limits for cleaning validation.


* Lead and participate in investigations and change controls.


* Prepare technical assessments for investigations and change controls.


* Represent MSAT in cross-departmental projects and global meetings.


* Maintain an excellent partnership with all business partners at the site and within J&J.


* Present cleaning validation during audits/inspections.


* Contribute to the digital transformation of MSAT (e.g., digitization and automation of reports, data management, visualization, evaluation of new technologies).
 

Qualifications:

As an ideal candidate, you have:


* A Bachelor’s or Master’s degree in Life Sciences or Engineering.
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