Manufacturing Technician, Fill Finish - 235600

Responsibilities:Complete and maintain aseptic qualification training.Gain foundational knowledge of tasks, unit operations, and documentation (formsSOPs) with guidance from Manufacturing Technician III or higher.Maintain gowning qualifications according to relevant SOPs.Follow SOPs, product batch record instructions, logbooks, forms, and related quality documentation accurately and consistently.Ensure real-time documentation is completed in accordance with cGMP and GDP standards.Maintain accurate documentation in compliance with cGMP and GDP ply with all environmental, health, and safety policies; actively identify and address unsafe conditions.Assist with QC sampling, equipment calibration, equipmentutility validation, and preventive maintenance as required.Collaborate with internal teams to meet site objectives and contribute to team success.Foster a cooperative and team-oriented environment across departments.Review and correct documentation as needed, escalating issues to supervision or Manufacturing Quality Associates (MQA).Maintain up-to-date personal cGMP training plete cleaning and sanitization training for cleanroom environments.Participate in aseptic media qualification according to protocol.Assist with investigations into deviations and conduct necessary risk assessments.Support personnel monitoring activities as needed.Work with Operational Excellence to identify and implement process improvements.Set up and break down filling equipment per SOPs.Transport equipment and components as needed.Operate filling machines at validated speeds and volumes.Perform volume checks and document inherentnon-inherent interventions.Maintain slow, deliberate movements in a Grade AB GMP aseptic environment.Collaborate with R&D and the tech transfer team for successful program transitions into the GMP area.Perform aseptic connections while respecting first air.Conduct pre- and post-filter integrity testing as required.Sterilize and aseptically transfer filter products into designated plete routine and enhanced cleaning and sanitization of aseptic cleanrooms as needed.Maintain ability to perform environmental tasks when required.Perform other duties as assigned.Qualifications:High school diploma or equivalent with 1-3 years of experience, a Bachelor's degree with at least 1 year of experience, or a combination of education and experience providing necessary knowledge and skills.Previous experience in a related field preferred.Familiarity with cGMP manufacturing preferred.Knowledge of aseptic filling and general production preferred.Basic math skills required.Ability to establish positive working relationships with colleagues, vendors, and supervisors.Technical knowledge to make informed decisions with minimal supervision.Ability to analyze data, resolve complex problems, and assess situations effectively.Proficient in following applicable SOPs.Familiarity with electronic Quality Management Systems (e.g., MasterControl, Trackwise) is a plus.Understanding of federal, local, and international regulations for drug substance and product production, testing, and release.Strong understanding of cGMPs, industry standards, and regulatory guidelines.Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, Project, Teams, Outlook).Demonstrated integrity and professionalism.Effective written and verbal communication skills with management, staff, regulators, and clients.Ability to complete tasks accurately within established and evolving timelines.Capable of making sound decisions on scheduling, resource allocation, and priorities.Energetic, results-driven, self-motivated, and well-organized in high-pressure, deadline-oriented environments.Creative, open-minded, and promotes idea-sharing within the fortable working with diverse customer and employee groups both internally and externally.Ability to collaborate effectively within cross-functional teams.Must be fluent in English and have legible handwriting.

Created: 2025-02-15