Aseptic Manufacturing Associate

Job Description

Job Title: Aseptic Manufacturing Associate

Location: Walkersville MD 21793

Duration: 6 Months

Job Type: Temporary Assignment

Work Type: Onsite

Shift: 1st Shift

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients worldwide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps its customers deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, bioscience, biopharmaceuticals, custom manufacturing, biotechnology, life science ingredients, nutrition, microbial control, agriculture, materials science, personal care, and cell and gene therapy.

Summary

The Manufacturing Associate I, Endotoxin / Aseptic Manufacturing Associate, is responsible for supporting upstream and/or downstream aseptic manufacturing of Limulus Amebocyte Lysate (LAL) products in an ISO 5 cleanroom environment. Performs equipment setup and operation in LAL filling and finishing areas, conducts product inspections, and packages finished products according to established procedures. Ensures compliance with cGMP, standard operating procedures (SOPs), good documentation practices, and site safety requirements while supporting production targets and continuous improvement initiatives.

Responsibilities

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• Perform aseptic manufacturing activities for LAL products in upstream and/or downstream production areas within an ISO 5 cleanroom environment.
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• Set up, operate, and maintain production equipment used in LAL filling and finishing operations.
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• Perform product inspections, inspection proficiency testing, component kitting, and final kit packaging of finished goods.
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• Complete required cleanroom and finishing training, including aseptic processing, gowning, equipment setup, equipment usage, and environmental monitoring.
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• Execute and qualify applicable SAP transactions related to manufacturing, production, material movements, and inventory management.
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• Maintain accurate GMP documentation and complete production records in accordance with established SOPs and GDP requirements.
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• Submit product samples and perform inspection activities according to approved procedures.
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• Follow cGMP requirements and applicable manufacturing protocols to ensure product quality and compliance.
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• Maintain a safe work environment by participating in safety discussions, safety observations, environmental protection and sustainability (EPS) observations, and 6S activities.
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• Support continuous improvement projects and contribute to production efficiency and operational excellence.
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• Maintain training compliance, meet personnel utilization targets, and minimize operator-related production records (PRs) and environmental monitoring (EM) excursions.
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• Identify and promptly report process deviations, documentation errors, product defects, safety incidents, and potential compliance risks.
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• Collaborate with team members and cross-functional departments to resolve routine production issues and meet manufacturing schedules.
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• Perform other duties as assigned.
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Required Skills

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• Associate degree in a science-related field preferred.
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• 0 to 4 years of experience in a manufacturing, production, laboratory, or regulated GMP environment.
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• Basic understanding of manufacturing processes, production workflows, and aseptic processing principles.
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• Familiarity with cleanroom practices, gowning procedures, and ISO 5 environments.
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• Basic knowledge of cGMP, Good Documentation Practices (GDP), SOPs, and production recordkeeping.
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• Ability to perform equipment setup, operate production equipment, and follow established operating procedures.
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• Basic understanding of laboratory techniques, scientific principles, and manufacturing quality requirements.
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• Basic mathematical, computer, and data-entry skills.
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• Familiarity with SAP transactions or similar manufacturing systems is beneficial.
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• Ability to perform product inspections, component kitting, sample submission, and packaging activities accurately.
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• Strong attention to detail and commitment to maintaining product quality and documentation accuracy.
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• Ability to follow instructions, perform routine troubleshooting, and escalate issues when necessary.
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• Strong teamwork, communication, and problem-solving skills.
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• Ability to work in a fast-paced, high-volume manufacturing environment while meeting production schedules and deadlines.
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• Adaptability, proactive behavior, and willingness to learn new processes and procedures.
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• Commitment to workplace safety, environmental protection, continuous improvement, and compliance with company policies.
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TekWissen® Group is an equal opportunity employer supporting workforce diversity.