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 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
Essential Duties:
- Assembly of cassette components. Following SOPs and training, assembly of cassettes ensuring quality and quantity are produced. This includes operation of trimming equipment, manual assembly of components into fixtures, and visual inspection of components. Ensure all process documentation is completed correctly and concisely. Ensure tooling is clean, functional, and operational.
- Single use device and Hardware assembly. 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.Additional duties:• Die Cutting. Cassette components are cut using process equipment, following SOPs, other documentation and training. Visual inspection of materials and cut component to internal quality standards. Use of correct tooling, ensuring quality and quantity are produced. Ensure tooling is clean, functional, and operational. Correct documentation of batch records and other documentation as required.• Encapsulation of components. Cassettes go through an encapsulation step(s), and the operator will be required to properly use process equipment and tooling to complete specific operations following SOPs, other documentation and training. Mixing of components and completion of Process documentation is required. Must be able to work with chemicals.• Final Inspection and Packaging. Following SOPs and training, perform visual inspection of tested product. Perform packaging of cassettes while working in a controlled environment, as well as placing finished bagged assemblies into boxes with additional components. Ensure all process documentation is completed correctly and concisely. May perform some data entry as required.
Other Functions:• 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
- Requires HS level education (Minimum)• Must be computer literate, preferably with MS Office and SAP• Ability to work independently once training has been completed• High attention to detail applied to all aspects of daily activities • Excellent organizational and communications skills• Must be resourceful and self-motivated in a fast paced environment• Ability to work efficiently in an ISO-9001 quality system with appropriate attention to detail in the performance of controlled procedures• Must be able to lift up to 50 lbs routinely
