Manufacturing Associate I - 1st Shift, TangenX

Overview

Reporting to the Manufacturing Supervisor, the Manufacturing Associate will perform various activities in the production of tangential flow filtration cassettes. The ability to successfully cross-train into other areas / functions may be required based on the changing needs of the department. The successful candidate will play a key role in ensuring that the department's production and quality goals are met. Applicants must have strong technical knowledge and problem-solving skills. The candidate must be able to follow oral and written instructions accurately (English), learn complex tasks quickly, and complete tasks in a timely manner. Many functions require standing / sitting for long periods of time and some frequent lifting up to 50 lbs. The successful candidate will actively follow Repligen ISO 9001 Quality Management System in support of the manufacturing processes and final product testing. Experience working in a classified cleanroom, and knowledge of GMP / ISO / document-controlled processes would be beneficial. Attention to detail, and the ability to work in a team environment are essential. Most operations require good hand-eye coordination and manual dexterity. The candidate must be computer literate with some MS Office experience.

Responsibilities

• Assembly of cassette components. Following SOPs and training, assembly of cassettes ensuring quality and quantity are produced. This includes manual assembly of components onto fixtures, and visual inspection of components. Ensure all process documentation is completed correctly and concisely. Ensuring the tooling is clean, functional, and operational.
• Following SOPs and training, perform assembly and visual inspection of product. Ability to read and follow drawings / Bill of Materials to complete components. Work in a controlled environment will be required for certain aspects of these operations. Ensure all process documentation is completed correctly and concisely. May perform some data entry as required.
• Following SOPs, other documentation and training. Visual inspection of materials and cut components to internal quality standards. Use correct tools, ensuring quality and quantity are produced. Ensure the tooling is clean, functional, and operational. Correct documentation of batch records and other documentation as required.
• Maintain cleanliness of workspace and tooling.
• Interface with QA representative and production personnel to maintain flow of product, as well as to identify non-conforming products
• Meet target of intermediate and long-term goals established by management. Long term goals will be established annually and followed by both the employee and management throughout the year.
• Additionally, you may be asked to help with the training of new hires in following procedures related to test methods used in performing their job
• Must be able to follow oral and written instructions accurately, learn complex tasks quickly, and complete tasks in a timely manner.
• Candidates must be willing and able to learn new manufacturing processes as the company grows and also to work overtime as needed (including weekends).

Qualifications

What Repligen Offers

Repligen offers you a competitive remuneration package, including a yearly bonus, non-contributory pension, generous PTO, partial compensation on your personal health insurance and flexible working hours. But most importantly Repligen offers you a stimulating, collaborative environment with steep learning curves and the opportunity to contribute to the healthcare of patients worldwide. All of this with an international team in Waltham, MA.

J-18808-Ljbffr