Werfen

Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company's business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Our North American Commercial Operations, as well as our Headquarters and Technology Center for Hemostasis and Acute Care Diagnostics, are based in Bedford, MA. Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA. Additionally, our Technology Center for Hemostasis and Blood Gas Reagents is in Orangeburg, NY, and our Technology Center for Whole Blood Hemostasis is in San Diego, CA.

Position Summary:

The TEM Production Operator utilizes an array of production equipment as well as manual assembly to manufacture and package TEM products.

Key Accountabilities:

• Assemble components of medical diagnostic devices in accordance with Good Manufacturing Practices (GMP) and all related standard operating procedures (SOPs).
• Perform in-process quality checks on sub-assemblies and finish products.
• Identify line issues and other production problems; promptly notify Team Leader or Supervisor of all problems.
• Support all efforts and procedures to maintain optimal manufacturing conditions.
• Maintain accurate records and documentation in accordance with Good Documentation Practices (GDP) and all related SOPs.
• Maintain safe working conditions at all times; adhere to all safety policies and procedures.
• Operate the following production equipment as directed and in accordance with all SOPs: Manual and semi-automated micro-fill.
• Product recipe controller air-dry and freeze-dry chambers (load, unload, operate).
• Various computer vision systems.
• Manual and semi-automated in-process inspection.
• Semi-automated tape, label, and barcode applicator machines.
• Manual and semi-automated pouch printing (pre-setting for production).
• Computer load printer (manual packaging and labeling by using final goods).
• Materials handling for processing and packaging.
• Ensure production areas are continually kept clean.
• Continually work to achieve assigned production goals.
• Prevent mix-up of products, materials, labels, and other components.
• As directed, provide support for process and equipment validation.
• Maintain daily product log books as directed.
• Ensure and maintain compliance with the Company's quality system requirements through training and adherence to policies, procedures and processes.
• Other duties as assigned.

Minimum Knowledge & Experience:

• High school diploma or equivalent.
• One (1) to two (2) years previous assembly/packaging experience; previous experience in a regulated medical device manufacturing or pharmaceutical environment strongly preferred.
• Familiarity with GDP and GMP a plus.
• Excellent hand-eye coordination needed. Basic written and verbal communication skills.

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 5,000 employees around the world comprise our Werfen team.

www.werfen.com