Aseptic Process Specialist

Zoetis•Atlanta, GA

1d•Onsite

About The Position

Zoetis is a global animal health company building a new manufacturing facility in the Metro Atlanta, Georgia, area to support its monoclonal antibody and vaccine portfolios. The Aseptic Process Specialist provides technical expertise for the Atlanta biologics manufacturing site, performs and supports aseptic manufacturing activities, and helps maintain compliance with GMP and applicable regulatory requirements. The role identifies and drives process improvements, represents manufacturing in the introduction of new or modified equipment and processes, and creates or completes SOPs, protocols, change controls, deviations, CAPAs, and effectiveness checks. In the facility’s startup environment, the specialist adapts to changing needs, helps develop and optimize processes, troubleshoots challenges, supports inventory and resource management, and collaborates across functions. Startup work may include FAT, SAT, CQV, media and engineering runs, and activities leading to stability batches. The role may also assist other departments, including Packaging, during production scale-up. The specialist works closely with engineering, maintenance, Global Manufacturing Technology, the Global Aseptic Team, vendors, and operations colleagues. They spend time in production examining processes and data, support training and knowledge transfer, and help ensure facility design and equipment changes reflect appropriate aseptic and compliance measures. The role includes subject-matter expertise across aseptic processing, cleanroom controls, manufacturing operations, and applicable GMP and regulatory requirements.

Requirements

Associate degree required.
Minimum 3–5 years of progressive experience as an Aseptic Technician at lead level or above in Manufacturing or Quality Operations.
Strong technical and analytical skills and a high degree of personal motivation.
Excellent interpersonal skills and ability to interact across divisional boundaries.
Strong technical experience relevant to aseptic processing and strong technical writing skills.
Ability to become qualified to enter cleanroom environments.
Knowledge of APHIS, FDA, and USDA regulations applicable to the pharmaceutical and biological industry.
Ability to use or work with PAS-X, SAP, Rotronic, Veeva, LMS, and TrackWise.

Nice To Haves

Bachelor’s degree in Engineering, Biology, Chemistry, Microbiology, Virology, Immunology, or a related technical field.
Experience in biological antigen production systems; biological product formulation, including blend, fill, or lyophilization; packaging; and/or testing.
Working knowledge of vaccine production methods and experimental design.
Experience in GLP or cGMP.
Experience in Lean/Six Sigma.

Responsibilities

Perform aseptic filling procedures while adhering to GMP requirements and maintaining a sterile environment.
Help establish, adapt, and optimize processes in the startup environment, including supporting FAT, SAT, CQV, media and engineering runs, and activities leading to stability batches.
Assist other departments, including Packaging, as needed during staffing and process scale-up.
Identify and drive continuous process improvements and support site aseptic-processing best practices.
Network with the Global Aseptic Team and partner with other sites to share and implement best practices.
Support Project Engineering and maintenance with the installation of equipment upgrades or new equipment, ensuring compliance with GMP requirements and suitability for manufacturing processes.
Support introduction of new processes and modifications to existing processes with Global Manufacturing Technology.
Train and guide colleagues on aseptic processes and their criticality, and collaborate with area Team Leaders on knowledge transfer.
Lead change and prepare or manage change controls, protocols, reports, data analysis, and project implementation.
Examine production processes and data, including environmental and temperature and humidity monitoring data, and take action to reduce bioburden and contamination and increase yield.
Deliver assigned cost-improvement projects, site metrics, and trend-related work.
Work with vendors to resolve aseptic and contamination issues.
Develop subject-matter expertise in facility design and environmental controls; cleaning and disinfection; gowning and aseptic technique; material transfer and movement; isolator and barrier systems; sterilization and validation; and bioburden reduction.
Develop expertise in mAbs manufacturing areas including Central Services, Solution Prep, Formulation, Vial Loading, Filling, and Capping.
Develop knowledge of GMP and regulatory requirements, compliance trends, industrial microbiology, microorganisms, contamination sources and control, measurement systems, and site data trends and metrics.
Assist in identifying and implementing Cost Improvement Projects and support the Operations team on financial-impact issues.
Conduct activities and make decisions in accordance with FDA guidance, company policies and SOPs, Zoetis Values, applicable global regulatory guidelines, and environmental guidelines.