Highlights
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.
Numbers & Facts
| Location | Walkersville, MD |
| Industry | Computer/IT Services |
| Salary | $20–$26 |
| Company Size | 100 to 499 employees |
| Year Founded | 2009 |
| Website | http://www.tekwissen.com/ |
Description
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.
Job Title: Aseptic Manufacturing Associate
Location: Walkersville MD 21793
Duration: 6 Months
Job Type: Temporary Assignment
Work Type: Onsite
Location: Walkersville MD 21793
Duration: 6 Months
Job Type: Temporary Assignment
Work Type: Onsite
Shift: 1st Shift
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
- Perform aseptic manufacturing activities for LAL products in upstream and/or downstream production areas within an ISO 5 cleanroom environment.
- Set up, operate, and maintain production equipment used in LAL filling and finishing operations.
- Perform product inspections, inspection proficiency testing, component kitting, and final kit packaging of finished goods.
- Complete required cleanroom and finishing training, including aseptic processing, gowning, equipment setup, equipment usage, and environmental monitoring.
- Execute and qualify applicable SAP transactions related to manufacturing, production, material movements, and inventory management.
- Maintain accurate GMP documentation and complete production records in accordance with established SOPs and GDP requirements.
- Submit product samples and perform inspection activities according to approved procedures.
- Follow cGMP requirements and applicable manufacturing protocols to ensure product quality and compliance.
- Maintain a safe work environment by participating in safety discussions, safety observations, environmental protection and sustainability (EPS) observations, and 6S activities.
- Support continuous improvement projects and contribute to production efficiency and operational excellence.
- Maintain training compliance, meet personnel utilization targets, and minimize operator-related production records (PRs) and environmental monitoring (EM) excursions.
- Identify and promptly report process deviations, documentation errors, product defects, safety incidents, and potential compliance risks.
- Collaborate with team members and cross-functional departments to resolve routine production issues and meet manufacturing schedules.
- Perform other duties as assigned.
Required Skills
- Associate degree in a science-related field preferred.
- 0 to 4 years of experience in a manufacturing, production, laboratory, or regulated GMP environment.
- Basic understanding of manufacturing processes, production workflows, and aseptic processing principles.
- Familiarity with cleanroom practices, gowning procedures, and ISO 5 environments.
- Basic knowledge of cGMP, Good Documentation Practices (GDP), SOPs, and production recordkeeping.
- Ability to perform equipment setup, operate production equipment, and follow established operating procedures.
- Basic understanding of laboratory techniques, scientific principles, and manufacturing quality requirements.
- Basic mathematical, computer, and data-entry skills.
- Familiarity with SAP transactions or similar manufacturing systems is beneficial.
- Ability to perform product inspections, component kitting, sample submission, and packaging activities accurately.
- Strong attention to detail and commitment to maintaining product quality and documentation accuracy.
- Ability to follow instructions, perform routine troubleshooting, and escalate issues when necessary.
- Strong teamwork, communication, and problem-solving skills.
- Ability to work in a fast-paced, high-volume manufacturing environment while meeting production schedules and deadlines.
- Adaptability, proactive behavior, and willingness to learn new processes and procedures.
- Commitment to workplace safety, environmental protection, continuous improvement, and compliance with company policies.
About Company
WE THE TEKWISSEN PEOPLE
TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.
To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.
Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.
It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.
Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.