Process Scientist

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Pulivarthi Group LLC is a Global Staffing & IT Technology Solutions company, with our prime focus of providing world class solutions to our customers with the right talent. We combine the expertise of our team and the culture of your company to help you with the solution that is affordable and innovative using high quality standards and technologies.

We’ve served some of the largest healthcare, financial services, and government entities in the U.S.

Job Title: Process Scientist

Company Overview

Pulivarthi Group is a premier global provider of staffing and IT technology solutions, renowned for delivering exceptional services tailored to each client's unique needs. With a steadfast commitment to excellence, we merge expertise with innovation, ensuring cost-effective solutions of the highest quality. Our diverse client base spans healthcare, finance, government, and beyond, reflecting our adaptability and proficiency across industries. Operating in the United States, Canada, and Mexico, we pride ourselves on aligning with clients' cultures, deploying top-tier talent, and utilizing cutting-edge technologies. Pulivarthi Group stands as a beacon of reliability, efficiency, and innovation in the realm of staffing solutions.

Job Overview/Summary

The Process Scientist supports assigned parenteral process areas (formulation, filling, or visual inspection) as the TSMS representative. This role serves as the technical interface for manufacturing equipment, components, and operations while leading risk management, investigations, and process improvement initiatives.

Responsibilities

• Support assigned parenteral process area (formulation, filling, or VI) as the TSMS representative.
• Serve as the technical interface for manufacturing equipment, components, and operations.
• Provide floor-level technical support during manufacturing operations and issue resolution.
• Lead or support non-routine investigations (e.g., deviations, complaints) and provide quality/stability consultation.
• Prepare, review, or approve technical documents such as:
• Annual Product Reviews
• Change Controls
• Regulatory Submissions
• Deviations
• Validation Protocols/Reports
• SOPs, PFDs, PFMEAs
• Lead risk management and process improvement initiatives.
• Develop and monitor real-time, statistically-based metrics for process control and capability.
• Drive stability strategy and harmonize control strategies across teams.
• Collaborate with upstream suppliers and the broader parenteral product network.
• Provide audit support and represent the Concord TSMS team in internal and external communications.
• Principal-level responsibilities also include:
• Mentoring TSMS team members and engineers.
• Representing the Concord site in cross-site and upstream engagements.
  

Primary Skills

• Technical support in cGMP manufacturing operations
• Investigation and problem-solving for deviations and complaints
• Preparation and review of technical documentation
• Risk management and process improvement leadership
  
  

Secondary Skills (Good To Have)

• Mentoring and team leadership
• Cross-site collaboration and stakeholder engagement
• Experience with stability strategy and control harmonization
  
  

Qualifications

• Education: Bachelor’s degree or higher in Engineering, Packaging Science, or a related scientific field.
• Experience: 2 years in cGMP manufacturing (validation, TSMS, QA, engineering, operations, etc.)
  
  

Benefits/Perks

• Competitive compensation
• Opportunities for career growth and development
• Inclusive and collaborative work environment
• Health, dental, and vision insurance options
  
  

Equal Opportunity Statement

Pulivarthi Group is proud to be an equal opportunity employer. We are committed to building a diverse and inclusive culture and celebrate authenticity. We do not discriminate on the basis of race, religion, color, national origin, gender, gender identity, sexual orientation, age, marital status, disability, protected veteran status, or any other legally protected characteristics.