Aseptic Manufacturing Technician Microbiology

Exela is currently looking for experienced and highly motivated microbiology personnel for a position in manufacturing operations to ensure aseptic processes are keenly executed.

Position Summary:

The Aseptic Manufacturing Technician plays a critical role in performing and supporting aseptic manufacturing activities. A strong background in microbiology and experience in aseptic manufacturing are required. The Aseptic Manufacturing Technician will actively participate on the production floor by working with a team of manufacturing professionals and performing aseptic interventions, environmental monitoring, and other microbiology and operational tasks. This newly created position offers a unique opportunity to microbiology professionals a non-traditional (outside the lab) pathway to advance rapidly in the pharmaceutical industry by providing a well-rounded manufacturing experience to take on higher level managerial roles in the industry.

Job Responsibilities:

· Maintain compliance with company policies, cGMP, safety standards, and regulatory requirements.

· Operate equipment on the production line via aseptic technique within a clean room space.

· Troubleshoot and escalate equipment issues when necessary.

· Address and escalate manufacturing, sterility, or quality concerns to the appropriate department leaders.

· Develop and implement strategies to improve aseptic manufacturing processes.

· Collect required samples needed for testing as required.

· Follow all required work safe practices.

· Hold peers accountable to all required work safe practices.

· Report process deviations to supervisor to mitigate product impact.

· Ensure the integrity of the cleanroom garb during manufacturing activities.

· Ensure personnel are maintaining the integrity of their cleanroom garb during manufacturing activities.

· Ability to wear full cleanroom garb for up to 5 hours at a time.

· Perform personnel monitoring of sterile garbed personnel.

· Perform compressed gas sampling to support manufacturing and/or qualification activities.

· Perform environmental monitoring such as viable air, total particulate air (non-viable), surface (RODAC), and swab sampling to support manufacturing and/or                 qualification activities.

· Perform aseptic interventions on the operating fill line.

· Participate in qualification activities such as media fills, protocols, and performance qualifications.

· Some part of the job requires working late or night shifts or a Pitman schedule as company needs evolve. The Pitman schedule allows plenty of personal/family time       for those willing to embrace the benefits of Pitman schedule.

· This position may be involved with the transportation and handling of hazardous waste; must successfully complete Resource Conservation Recovery Act (RCRA)           training within 1 year of hire, and annually thereafter.

Required Skills:

· Strong understanding of microbiology, aseptic techniques, and manufacturing practices.

· Knowledge of cGMP and pharmaceutical regulations.

· Strong communication and interpersonal skills.

· Excellent problem-solving and decision-making skills.

· Ability to multi-task and work under pressure with time constraints.

· Flexibility to adapt to changes in task priority.

Experience and Education Requirements:

· Bachelor of Science (BS) degree in Microbiology, Biology, or related Life Sciences.

· 1 years of experience in aseptic manufacturing within the pharmaceutical or biotech industry.