Process Analytical Technology (PAT) SME

Key Responsibilities

·       Supported the expansion,
optimization, and ongoing maintenance of a large -scale PAT framework within a
GMP -regulated biopharmaceutical manufacturing site.

·       Installed, configured, and
maintained Siemens SIPAT infrastructure, including central databases, base
stations, and collector stations.

·       Developed, configured, and
executed SIPAT methods, multivariate models, and automated interventions for
real -time process control.

·       Designed and generated
analytical and compliance reports using SAP Business Objects to support process
monitoring and decision -making.

·       Collaborated with
cross -functional teams to plan and execute major system upgrades between SIPAT
versions, ensuring minimal disruption to manufacturing operations.

·       Authored and executed
validation documentation, including Installation Qualification (IQ) and
Operational Qualification (OQ), ensuring compliance with regulatory standards
(e.g., FDA, GMP).

·       Provided technical support and
troubleshooting for PAT systems, ensuring data integrity and system
reliability.

·       Contributed to continuous
improvement initiatives by enhancing PAT capabilities and aligning with
evolving manufacturing and regulatory requirements.

Requirements

·       Bachelor’s degree in Engineering, Pharmaceutical Sciences, Chemistry, or
a related scientific/technical field (Master’s preferred).

·       3–7+ years of experience in biopharmaceutical or pharmaceutical
manufacturing environments.

·       Hands -on experience with Siemens SIPAT or similar Process Analytical
Technology (PAT) platforms.

·       Strong understanding of PAT principles, multivariate data analysis, and
real -time process monitoring.

·       Experience with system configuration, including databases,
instrumentation interfaces, and data acquisition systems.

·       Familiarity with reporting tools such as SAP Business Objects or
equivalent platforms.

·       Demonstrated experience with Computer System Validation (CSV), including
IQ/OQ (PQ is a plus).

·       Solid knowledge of GMP regulations and FDA guidelines related to
pharmaceutical manufacturing systems.

·       Experience supporting or executing system upgrades and lifecycle
management in regulated environments.

·       Strong problem -solving skills with the ability to troubleshoot complex
technical systems.

·       Excellent communication and collaboration skills, with experience
working in cross -functional teams.

Why Join Catalyx?

At Catalyx we understand that our people are our greatest
asset. For this reason and many others, we take care of them. The team in
Catalyx benefits from a Total Rewards package. This includes great personal
benefits and professional growth opportunities.

Catalyx is an Equal Opportunity Employer. We are committed
to creating a diverse and inclusive workplace where all individuals are valued,
respected, and supported. We do not discriminate on the basis of race, color,
religion, sex (including pregnancy, gender identity, and sexual orientation),
national origin, age, disability, veteran status, genetic information, or any
other characteristic protected by applicable law. We encourage applications
from all qualified candidates, regardless of background, and strive to create a
welcoming environment for everyone.

At Catalyx, we are committed to attracting the best global
talent. We proudly support our international employees by offering assistance
with Critical Skills Visa applications for eligible candidates.