Principal Process Scientist

Job DescriptionJob DescriptionAbout Company:JC Automation Corp. (JCA) was founded in 1997 with the mission of filling a gap between technology and regulatory requirements in the life science manufacturing industry. The company offers highly capable resources at an affordable cost to build solutions and execute projects in: Automation, Control Systems Integration, Information Technology, System Integration and Regulatory Compliance.JCA is a HUBZone Certified Small Business Firm, NMSDC Certified Minority Business Enterprise, and Certified Critical Industry Supplier. It’s mission is to add value by delivering quality services & solutions on time all the time by transforming processes & technology into business advantages.ABOUT THE ROLEWe are seeking a Principal Process Scientist to serve as the Subject Matter Expert (SME) for sterile manufacturing processes, with specialized focus on liquid and lyophilized parenteral products.

This senior-level role combines deep scientific expertise with hands-on operational support, driving process optimization, compliance, and technology transfer in a cGMP pharmaceutical environment.The ideal candidate brings extensive experience in manufacturing operations, complex investigations, process validation, and cross-functional leadership, ensuring strategic alignment with site priorities and regulatory requirements.

RESPONSIBILITIESSubject Matter Expertise (SME): Serve as the primary technical authority for sterile manufacturing processes, including liquid and lyophilized parenteral products, providing guidance to manufacturing, engineering, quality, and validation teams.Daily Manufacturing Support: Support daily manufacturing operations with advanced technical expertise, ensuring processes operate within validated parameters and in compliance with cGMP and site procedures.Troubleshooting & Process Optimization: Lead technical troubleshooting efforts for manufacturing deviations and process-related issues. Drive continuous process optimization to improve yield, efficiency, and product quality.Investigations & CAPA Management: Lead and manage complex investigations, including root cause analysis for deviations. Develop and implement effective Corrective and Preventive Actions (CAPAs) to prevent recurrence.Process Validation: Plan and execute process validation activities, ensuring all protocols, reports, and supporting documentation meet regulatory and internal standards.Technology Transfer: Lead technology transfer efforts for new or existing products, coordinating with cross-functional teams to ensure successful scale-up and site integration.Regulatory Compliance: Ensure strict adherence to cGMP regulations, FDA guidelines, and internal site procedures.

Support regulatory inspections and audits as the technical SME for sterile manufacturing processes.

REQUIREMENTS & QUALIFICATIONSRequiredBachelor's, Master's, or Ph.D. in Life Sciences, Chemical Engineering, Pharmacy, Bioengineering, or a closely related scientific discipline.Extensive background in sterile manufacturing processes with specialized focus on liquid and lyophilized parenteral products.Proven experience supporting daily manufacturing operations and providing advanced technical troubleshooting.Demonstrated capability in managing complex investigations, root cause analysis, and CAPA implementation.Hands-on experience executing process validation activities and leading technology transfer efforts.Deep understanding of cGMP regulations, FDA guidelines, and compliance requirements in a highly regulated pharmaceutical environment.Exceptional cross-functional collaboration skills with manufacturing, engineering, quality, and validation teams.

PreferredPh.D. or advanced degree with focus on sterile pharmaceutical manufacturing or bioprocessing.Experience supporting FDA or EMA regulatory inspections as a process SME.Familiarity with lyophilization process development and scale-up.Experience with statistical tools for process monitoring and data analysis (e.g., JMP, Minitab).

SKILLSTechnical SkillsSterile manufacturing processes — liquid and lyophilized parenteral productsProcess validation (IQ/OQ/PQ/PPQ) and technology transferDeviation management, root cause analysis, and CAPA systemscGMP regulations, FDA guidelines, and regulatory documentationContinuous process improvement and optimization methodologiesTechnical writing — protocols, reports, SOPs, and investigation summariesMicrosoft Office 365

Soft SkillsSenior-level technical leadership and SME authorityStrong cross-functional collaboration and stakeholder alignmentAnalytical mindset with structured problem-solving capabilitiesAbility to manage multiple priorities in a fast-paced regulated environmentClear scientific communication across technical and non-technical audiencesAdaptability and availability to support other shifts as business needs require