Job Title: Aseptic Manufacturing Technician

Job Description

As an Aseptic Manufacturing Technician for Commercial Drug Products, you will perform a variety of tasks including formulations, calculations, compounding, filtration, syringe and vial fills, and media preparations. You will also operate autoclave, sterile instruments, and glassware. You will be responsible for supporting GMP Fill Finish manufacturing processes and ensuring the aseptic production of finished drug product biologics for clinical and commercial use.

Responsibilities

• Complete and maintain aseptic qualification training.
• Obtain a basic understanding of tasks, unit operations, and documents while receiving oversight from the managing technicians.
• Attain and maintain gowning qualification per SOPs.
• Follow SOPs, product batch record instructions, logbooks, forms, and quality documentation in detail.
• Prepare and maintain accurate documentation following cGMP and GDP principles.
• Ensure real-time documentation completion in accordance with cGMP and GDP principles.
• Adhere to all environmental, health, and safety policies and procedures, proactively identifying unsafe conditions.
• Support QC sampling, equipment calibration, equipment/utility validation, and preventive maintenance as needed.
• Collaborate with internal teams to meet site goals and objectives.
• Foster cooperation within and between departments.
• Review documentation for accuracy, make corrections, and escalate issues as needed.
• Maintain current cGMP-related training.
• Achieve and maintain cleanroom training for cleaning and sanitization.
• Participate in aseptic media qualification per the appropriate protocol.
• Support manufacturing in deviation investigations and perform required risk assessments.
• Participate in personnel monitoring as requested.
• Work with Operational Excellence to identify and implement process improvements.
• Set up and breakdown filling equipment per SOPs.
• Interact with filling machines at validated speeds and volumes.
• Perform volume checks and document interventions.
• Ensure appropriate movements for a Grade A/B GMP aseptic environment.
• Work with R&D and tech transfer teams for successful program transfers.
• Perform all aseptic connections, respecting first air.
• Perform pre- and post-filter integrity testing as required.
• Aseptically sterile filter products into appropriate vessels.
• Complete routine and enhanced cleaning and sanitization of controlled aseptic cleanrooms.
• Attain and maintain ability to perform environmental tasks as required.
• Perform other duties as assigned.

Essential Skills

• Aseptic technique
• Sterile injectables
• cGMP manufacturing knowledge
• Downstream processing
• Cleanroom operations
• Laboratory skills
• Compounding and batch processing
• Autoclave operation
• Pharmaceutical manufacturing
• Gowning procedures
• Basic math skills
• Ability to establish good working relationships
• Technical knowledge for decision-making
• Data analysis and problem-solving
• Comprehension of SOPs
• Experience with electronic Quality Management Systems (e.g., MasterControl, Trackwise)
• Knowledge of federal, local, and international regulations
• Understanding of industry and regulatory standards
• Familiarity with Microsoft programs (Word, Excel, PowerPoint, Project, Teams, Outlook)
• Integrity and professionalism
• Effective communication skills
• Ability to complete tasks accurately and on time
• Quality decision-making in scheduling and resource allocation
• Energetic, self-motivated, and organized

Additional Skills & Qualifications

• High school diploma or equivalent with 1-3 years of experience, Bachelor’s degree with a minimum of 1 year of experience, or equivalent combination of education, training, and professional experience.
• Prior experience in related field preferred.
• Knowledge of cGMP manufacturing preferred.
• Aseptic filling and general production knowledge preferred.

Work Environment

You will be working in a Class 100 manufacturing cleanroom, which maintains less than one hundred particles larger than 0.5 microns in each cubic foot of air space (equivalent to ISO Class 5 cleanroom). You must gown up when entering the cleanroom.

Pay and Benefits

The pay range for this position is $60000.00 - $80000.00/yr.

Jabil is taking over, will update when they are sent over.

Workplace Type

This is a fully onsite position in Hunt Valley,MD.

Application Deadline

This position is anticipated to close on Apr 4, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $60,000 - $80,000