About this Laboratory Technician, Environmental Monitoring and Clean Utilities role at LOTTE BIOLOGICS USA, LLC
We are LOTTE BIOLOGICS! Delivering Therapies That Enable a Healthier World.
A new company, built on 80 years of tradition. We embody our core values of being Inspired by Science, Embracing Diversity, Fostering Talent, and Connecting Lives. Our mission is to be the most trusted partner in the industry, with high standards of quality and continuous innovation, to reliably deliver benefits for patients worldwide.
Position Summary
The Aseptic Quality Operations (AQO) group supports the onsite commercial manufacturing facility. The Environmental Monitoring and Clean Utilities Laboratory Technician conducts routine EM and Utility monitoring in compliance with procedures, protocols, and regulatory requirements.
Duties & Responsibilities
- Conducts routine sampling and microbiological analyses of environmental monitoring and a variety of clean utility systems using aseptic technique and in compliance with established procedures and regulatory requirements.
- Must be capable of maintaining laboratory documentation associated with testing and investigations in areas of assigned responsibility.
- Must analyze, evaluate, and interpret data, notifying clients of results and assisting to resolve issues, if applicable. Identify and report any discrepancies from normal procedures or practices.
- Maintains a level of technical knowledge and understanding in the assigned area of responsibility, including use of equipment and instrumentation and is able to troubleshoot problems, if they occur.
- Support the implementation of new methods and equipment/instrumentation by performing required testing in support of validations, qualifications, or suitability testing.
- Must update and write new procedures, protocols, and reports, as requested.
- This position is a team-based position that requires rotating shift work, weekends, holidays and overtime.
Education & Experience
Minimum Qualifications:
- Associate of Applied Science degree in Biological Sciences or a related life sciences field.
- 0-3 years of relevant laboratory, microbiology, environmental monitoring, quality control, or manufacturing experience.
Preferred Qualifications:
- Experience working in a pharmaceutical, biotechnology, medical device, or other cGMP-regulated environment.
- Experience with environmental monitoring, aseptic sampling, microbiological testing, or clean utility systems.
- Experience performing laboratory investigations, data review, and documentation in a regulated environment.
Knowledge, Skills, Abilities
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Knowledge of microbiology, environmental monitoring, clean utility systems, aseptic processing, and cGMP requirements.
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Skill in aseptic sampling, microbiological testing, laboratory documentation, and data analysis.
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Ability to interpret results, identify and communicate discrepancies, troubleshoot routine issues, and support investigations.
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Ability to learn and apply new methods, equipment, and technologies.
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Effective communication, organizational, and teamwork skills with strong attention to detail.
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Ability to work independently while maintaining quality, safety, and compliance standards.
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Proficiency with laboratory software and electronic documentation systems.
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Demonstrates LOTTE's core values and adaptability in a fast-paced manufacturing and laboratory environment, including support for rotating shifts, weekends, holidays, and overtime.
Physical Demands
This position is located in a medium scale manufacturing facility with classified areas requiring appropriate personal protective equipment (PPE) and in an Environmental Laboratory. This role will require contact with hazardous materials such as caustic, acids and steam. Frequent bending, twisting, squatting, kneeling, climbing and reaching is required. Role also requires frequent unassisted lifting (not to exceed 50 lbs). Repetitive use of arms/hand/wrists, grasping is also required.
Work Environment
This position will require contact with chemicals on an infrequent basis. This position is based indoors in a medium scale manufacturing facility and in a laboratory. You will be working alone and working with/around others frequently. You will be dealing with temperature extremes (heat/cold) frequently as well as noise = >85 dBA.
Target Bonus
5%
Work Location:
East Syracuse, NY
We are an Equal Employment Opportunity (“EEO”) Employer.
We believe that women, people of color, veterans and LGBTQ communities must participate in the work we do, so we strongly encourage applications from people with these identities or who are members of underrepresented communities! If this is the work that you want to do, in a culture of inclusion and excellence with the goal of making our world to be a healthier place, then please apply today!
