Manufacturing Associate I - ELISA Plates
Werfen
Summary
Join Werfen's Autoimmunity business as a Manufacturing Associate I and play a key role in producing diagnostic products that help clinicians around the world detect autoimmune disorders. As a Manufacturing Associate within our ELISA Plates team, you'll operate and maintain specialized manufacturing equipment, support the production of ELISA plates, monitor quality throughout the process, and ensure products are stored and handled according to established procedures. You'll spend your day setting up equipment, overseeing production runs, inspecting materials, documenting work, and contributing ideas that improve efficiency and quality. Working alongside a supportive and collaborative team, you'll have the opportunity to develop expertise in regulated manufacturing environments while building skills in troubleshooting, equipment validation, and continuous improvement, creating a strong foundation for long-term career growth within Werfen.
Job description
Key Accountabilities
- Under supervision follows standard operating procedures, work instructions, and other procedures for routine manufacturing and/or testing.
- Participates in the bulking and/or evaluation of in-process components and reagents according to procedures.
- Packages, fills, and operates equipment to ensure in-process components are completed (if applicable).
- Maintains detailed Device History Records and/or any other associated documentation for all manufacturing activities.
- Operates and cleans equipment and instrumentation for routine manufacturing and/or testing.
- Assists with evaluations of raw materials (if applicable).
- Follows established safety and environmental procedures.
- Maintains lab and work area in a clean and orderly manner.
- Complies with applicable Werfen standard operating procedures (SOPs), ISO, FDA and other Quality System regulations, as well as applicable Environmental Health & Safety (EHS), Human Resources and other regulatory and company policies.
- Reflects Werfen Values in the quality of work and in working relationships.
Networking/Key relationships
- Other Manufacturing teams
- Operations teams, including Equipment Engineering, Facilities & Environmental Health & Safety (EHS)
- Shared Services teams, including Filling and Packaging
- Product Testing team
- Manufacturing Technical Service
- Global Systems Support
Minimum Knowledge & Experience for the position
Education: Bachelor's degree in biological or related sciences required. Certificate program or A.S. degree with 3-4 years relevant experience in a life sciences laboratory may be substituted for a degree.
Experience: 0-1 years of life sciences laboratory experience required. Experience in a regulated manufacturing environment in the healthcare sector strongly preferred.
Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.
Skills & Capabilities
- Basic understanding of basic laboratory practices and procedures.
- Basic understanding of Good Manufacturing Practices.
- Strong attention to detail and commitment to quality.
- Attentiveness to details to spot flaws in products or problems with equipment to prevent quality issues.
- Problem-solving ability to troubleshoot and resolve issues.
- Time management skills to meet production goals without compromising quality.
- Ability to work collaboratively in a team environment.
- Curiosity and commitment to continuous learning.
Requirements
- Bachelor's degree in biological or related sciences required
- Certificate program or A.S. degree with 3-4 years relevant experience in a life sciences laboratory may be substituted for a degree
- 0-1 years of life sciences laboratory experience required
- Experience in a regulated manufacturing environment in the healthcare sector strongly preferred
- Basic understanding of basic laboratory practices and procedures
- Basic understanding of Good Manufacturing Practices
- Strong attention to detail and commitment to quality
- Attentiveness to details to spot flaws in products or problems with equipment to prevent quality issues
- Problem-solving ability to troubleshoot and resolve issues
- Time management skills to meet production goals without compromising quality
- Ability to work collaboratively in a team environment
- Curiosity and commitment to continuous learning
Benefits
- Medical, Dental & Vision
- 401(k) Matching
- Paid Vacation
- Sick Leave
- Performance-Based Bonus
Company overview
Werfen is a global leader in specialized diagnostics, founded in 1966 in Barcelona, Spain as a family-owned innovative company. The organization has established itself as a worldwide authority in five key clinical areas: Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant diagnostics. With headquarters in Barcelona and technology centers strategically located in the United States and Europe, Werfen operates directly in 30 countries and serves more than 100 territories through distributors. The company achieved remarkable financial performance with worldwide sales exceeding €2.2 billion in 2024, supported by a workforce of over 7,000 employees globally. Werfen's comprehensive portfolio includes advanced diagnostic systems, reagents, laboratory automation solutions, and point-of-care testing platforms that enable healthcare providers to deliver precise and timely patient care. Their innovative technologies span from blood gas analyzers with hemolysis detection capabilities to automated immunoassay systems and specialized diagnostic assays. As a vertically integrated diagnostics company, Werfen maintains complete control over research, development, manufacturing, and distribution, ensuring quality and reliability across their product lines while continuously advancing diagnostic science to address critical healthcare challenges worldwide.