MSAT Cleaning Validation Specialist

JNJ Cork Small Molecule is recruiting for a MSAT - Cleaning Validation Specialist, located in Little Island

Cork SM site at Little Island, Cork, is part of JNJ Innovative Medicine team.

The site has a successful history over 40 years of meeting patient needs.

The site manufactures Small Molecule API for distribution throughout the JNJ network.

As a core member of the Manufacturing Science and Technology (MSAT) Team, the MSAT Cleaning Validation Specialist at Johnson & Johnson plays a vital role in ensuring the flawless operation of our production value streams.

With a focus on optimization and innovation, you will have the opportunity to lead new insights and advancements in our business unit, contributing to our world-class manufacturing processes.
Responsibilities
Cleaning Validation

Maintain/update input to the Cleaning Validation Master Plan to support the multi-product drug substance manufacturing facility.

Benchmark against global guidance and build plans to drive improvement of local standards!

Partner with external cleaning agencies and companies to develop and wider improvement strategy

Generate and implement cleaning validation protocols as required.

Provide input to Standard Operating Procedures (SOPs) and Work Instructions (WI) to enable suitable cleaning sampling activities to occur.

Ensure compliance with site EHS policy, cGMP and other business regulations and support MSAT input to risk assessments, audits, regulatory inspections and incident investigations.

Own the Cleaning risk closure process at senior quality meetings.

Identify trends in cleaning deviation trends and collaborate with the wider MSAT and Operations team to implement changes improve performance.

Author and review process transfer/cleaning documentation, cleaning risk assessments, deviations, technical protocols and reports, cleaning verification/validation documents and supporting documentation as the need arises.Education:


* Bachelor/ Master of Chemical Engineering, or a related field / PhD


* Strong communication and collaboration skills, with the ability to work effectively in diverse teams.

At Johnson & Johnson, we are an equal opportunity employer Experience and Skills:
Required:


* Experience in API manufacturing, and Cleaning processes is needed


* Solid understanding of cleaning validation and program implementation.


* Consistent track record to lead and complete sophisticated investigations, resolving root causes and implementing effective corrective actions.


* Knowledge of API Cleaning standards is required


* Experience in driving process improvement projects

Other:


* Language requirements - English


* 10% Travel percentage - national or international.


* Day role