Aseptic Manufacturing Technician

Job Overview:

The Manufacturing Technician is responsible for supporting the overall GMP Fill Finish manufacturing processes, through the application of broad knowledge of theories, techniques, and principles utilized to solve operational and routine tasks in the aseptic production of finished drug product biologics for commercial GMP manufacturing. The Manufacturing Technician will be responsible for the filtration and filling of a range of pharmaceutical products for clinical and commercial use.

Responsibilities:

and maintain aseptic qualification training.

basic understanding of a task, unit operation and/or document (forms and/or SOPs) while aiding with oversight from Manufacturing Technician III and above.

and maintain gowning qualification per appropriate SOPs.

SOPs, product batch record instructions, logbooks and forms, and corresponding quality documentation in detail.

and maintain accurate documentation following cGMP and GDP principles.

documentations are completed in real-time in accordance to CGMP and GDP principles.

to all environmental, health, and safety policies and procedures and proactively identify unsafe conditions.

QC sampling, equipment calibration, equipment/utility validation, and preventive maintenance as needed.

collaboratively with internal teams to meet site goals and objectives as part of a team.

and foster a spirit of cooperation within and between departments.

documentation for accuracy, makes corrections and/or escalates to supervision/Manufacturing Quality Associate (MQA).

all personal cGMP related training in a current state.

and maintain cleaning and sanitization of cleanroom training.

in Aseptic media qualification per the appropriate qualification protocol.

manufacturing in the investigation of deviations and performs required risk assessments.

in personnel monitoring as requested.

closely with Operational Excellence to identify and implement process improvements.

up and breakdown the filling equipment per appropriate SOPs.

equipment and components as needed.

with filling machines at the validated speeds and volumes.

volume checks.

and document inherent and non-inherent interventions.

slow and purposeful movements appropriate for a Grade A/B GMP aseptic environment.

with R&D and tech transfer team for successful transfer of Programs into the GMP area

all aseptic connections, respecting first air.

pre- and post-filter integrity testing as required.

sterile filter products into appropriate vessels.

routine and enhanced cleaning and sanitization of all controlled aseptic cleanrooms, as needed.

and maintain ability to perform environmental tasks as required.

other duties as assigned.

Qualifications:

school diploma or equivalent with 1-3 years’ experience, Bachelor’s degree with a minimum of 1 year of experience, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.

experience in related field, preferred.

manufacturing knowledge, preferred.

filling and general production knowledge, preferred.

basic math skills.

the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates.

the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.

the ability to analyze data and information and assess and resolve complex problems/issues as required.

be able to comprehend and follow all applicable SOPs.

knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.

ability to acquire the appropriate knowledge from resources on the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.

understanding of cGMPs, industry, and regulatory standards and guidelines.

familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.

the ability to portray the appropriate level of integrity and professionalism.

the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats.

the ability to complete tasks accurately and according to established and shifting timelines.

the ability to make quality scheduling, resource allocation, and priorities decisions.

execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.

and efficient.

and open-minded who fosters an environment in which sharing of ideas is encouraged.

the ability to work closely with a diverse customer and employee base (internally and externally).

the ability to work well in a cross-functional team environment.

communicate fluently in English and have legible handwriting.

Physical Demands:

to travel between and within facilities to visit staff, operations, and projects, as needed.

to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).

to lift up to 40 pounds on occasion.

to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).