Principal Process Scientist

Job Description

Job Description

About 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 ROLE

We 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.

RESPONSIBILITIES

• Subject 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 & QUALIFICATIONS

Required

• Bachelor'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.

Preferred

• Ph.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).

SKILLS

Technical Skills

• Sterile manufacturing processes — liquid and lyophilized parenteral products
• Process validation (IQ/OQ/PQ/PPQ) and technology transfer
• Deviation management, root cause analysis, and CAPA systems
• cGMP regulations, FDA guidelines, and regulatory documentation
• Continuous process improvement and optimization methodologies
• Technical writing — protocols, reports, SOPs, and investigation summaries
• Microsoft Office 365

Soft Skills

• Senior-level technical leadership and SME authority
• Strong cross-functional collaboration and stakeholder alignment
• Analytical mindset with structured problem-solving capabilities
• Ability to manage multiple priorities in a fast-paced regulated environment
• Clear scientific communication across technical and non-technical audiences
• Adaptability and availability to support other shifts as business needs require