Tallo logoTallo logo

Process Analytical Technology (PAT) Subject Matter Expert

Job

Catalyx

Baltimore, MD (In Person)

Full-Time

Posted 4 weeks ago (Updated 3 weeks ago) • Actively hiring

Expires 5/28/2026

Apply for this opportunity

This job application is on an outside website. Be sure to review the job posting there to verify it's the same.

Review key factors to help you decide if the role fits your goals.
How is this calculated?
Pay Growth
?
out of 5
Not enough data
Not enough info to score pay or growth
Job Security
?
out of 5
Not enough data
Calculating job security score...
Total Score
65
out of 100
Average of individual scores

Were these scores useful?

Skill Insights

Compare your current skills to what this opportunity needs—we'll show you what you already have and what could strengthen your application.

Job Description

Seeking a Process Analytical Technology (PAT) Subject Matter Expert supporting the implementation, expansion, and lifecycle management of PAT systems within a biopharmaceutical manufacturing environment. Specialized in configuring and maintaining Siemens SIPAT to enable real-time process monitoring, data integrity, and regulatory compliance. 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.

Similar remote jobs

Similar jobs in Baltimore, MD

Similar jobs in Maryland