Aseptic Process Specialist

Responsibilities in a Startup Environment

In a startup environment, the Aseptic Process Specialist will adapt quickly to changes, lead in developing and optimizing new processes, and identify opportunities for innovation and improvement. This role involves close collaboration with cross-functional teams, managing inventory and resources efficiently, and troubleshooting unexpected challenges. The technician will also contribute to scaling production processes, participate in diverse tasks to support the dynamic needs of the startup, and ensure the sustainability and scalability of all procedures as the company grows. Specific activities would include FAT, SAT, CQV, media and engineering runs that lead to stability batches. The successful candidate will need to be flexible to perform activities outside of the standard aseptic requirements in order to assist other departments, including Packaging during scale up of staffing and processes.

Position Summary

Provide technical expertise for the Atlanta biologics manufacturing site. Identify and drive continuous process improvements. Represent manufacturing in the introduction of new/modified aseptic equipment and processes. Create/complete and write SOP's, protocols, change controls, deviations, CAPA's and effectiveness checks. Partner with EMU during Capital Planning to ensure facility design encompasses the appropriate aseptic measures from a compliance and aseptic perspective. Lead major investigations including contamination, repeat deviations, and equipment failures. Partner with other sites to ensure Atlanta is following best practices. Conduct all activities and make decisions that are in accordance with FDA guidance, Company policies & SOPs, Zoetis Values, & global regulatory guidelines (including cGMP/cGLP/cGCP), environmental guidelines, as appropriate, etc.

Position Responsibilities

• Assist in addressing, implementing and improving best practices in aseptic processing across the site. Network with the Global Aseptic Team to share best practices.
• Support Project Engineering and/or maintenance on installation of upgrades or new equipment to ensure the changes comply with GMP regulatory requirements and are suitable for our manufacturing processes.
• Assist with the introduction of new processes or modifications to existing processes as supported by Global Manufacturing Technology (GMT). Liaison with colleagues to ensure they are trained and understand the criticality of the aseptic processes work they are conducting.
• Support aseptic and other continuous improvement efforts. Be proficient in leading change, writing change control documents, protocols, reports, analyzing data and managing/coordinating all aspects of project implementation.
• Spend time in the production environment, examining the processes and reviewing the data (example - environmental monitoring and temperature and humidity monitoring using Rotronic). Identify best practices and take action to reduce bioburden, contamination and increase yield.
• Deliver on assigned cost improvement projects, site metrics and trends.
• Work with vendors to resolve possible aseptic and contamination issues.
• Collaborate with area Team Leader to train and lead colleagues in the performance of best practices and skilled knowledge transfer of processes.
• Become a subject matter expert on all areas related to Aseptic Processing to include: Facility Design / Environmental Controls; Cleaning and Disinfection; Aseptic and Controlled Area Gowning; Aseptic Training / Good Aseptic Technique; Material Transfer; Material/Personnel/Equipment Flow and Movement; Use of Isolator and Barrier Systems; Sterilization / Validation; Bioburden Reduction; Equipment and area within mAbs (Central Services, Solution Prep, Formulation, Vial loading, Filling, Capping); GMP/Regulatory Requirements (Compliance Trends, Basic Industrial Microbiology, Types of Microorganisms, Growth and Reproduction, Sources of Cleanroom Contamination, Reduction/Elimination, Measurement Systems, Site Specific Data Trends and Metrics).

Financial Accountability

• Assist with identifying and implementing delivering Cost Improvement Projects (CIP).
• The Aseptic Specialist supports the Operations team regarding financial impact issues.

Education and Experience

• Associates degree required; Bachelor's degree preferred in Engineering, Biology, Chemistry, Microbiology, Virology, Immunology, or related technical field.
• Minimum 3-5 years of progressive experience as an Aseptic Technician Lead level or above, in Manufacturing or Quality Operations is required.
• Must have strong technical/analytical skills and possess a high degree of personal motivation.
• Excellent interpersonal skills and ability to interact across divisional boundaries.

Technical Skills Requirements

• PAS-X
• SAP
• Rotronic
• Veeva
• LMS
• Track Wise
• Strong technical experience specific for this role.
• Strong technical writing skills.
• Preferred experience in biological antigen production systems, biological product formulation (blend/fill/lyophilization), packaging, and/or testing.
• A working knowledge of vaccine production methods and experimental design and experience in GLP or cGMP.
• Knowledge of APHIS, FDA, USDA regulations applicable to the Pharmaceutical/Biological industry.
• Preferred experience in Lean/Six Sigma.

Physical Position Requirements

• Able to become qualified to enter clean room environments.
• Physical Demands Include: Sitting, Writing, Typing, Talking, Hearing, Seeing, Lifting.
• Work Environment: While performing the duties of this job, the employee occasionally works in environments with extreme temperature (hot/cold) & humidity, with limited lighting and in crowded spaces. The noise of these work environments is typical of office and manufacturing settings.
• Use of personal protective equipment is required.