Job Description

Responsibilities:

• Complete and maintain aseptic qualification training.
• Gain foundational knowledge of tasks, unit operations, and documentation (forms/SOPs) 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 principles.
• Comply with all environmental, health, and safety policies; actively identify and address unsafe conditions.
• Assist with QC sampling, equipment calibration, equipment/utility 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 records.
• Complete 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 inherent/non-inherent interventions.
• Maintain slow, deliberate movements in a Grade A/B 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 vessels.
• Complete 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 team.
• Comfortable 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.

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