Manufacturing Associate I - 2nd Shift, ATF

Overview

Reporting to the Manufacturing Supervisor, the Manufacturing Associate will perform various activities in the production of alternating tangential flow single use devices. 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 frequently 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 both independently and 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 single use ATF devices. Following SOPs and training, assembly of suATF devices ensuring quality and quantity are produced. This includes assembling components for suATF devices, read and follow drawings, maintaining lot traceability of components, using machine to conduct integrity testing, using tools during assembly (including hand tools, torque wrenches, tube cutters), visual inspection of components, and packaging devices. Ensure all process documentation is completed correctly and concisely in electronic batch records. Ensure tooling is clean, functional, and operational. May perform some data entry as required. Tasks include frequently lifting devices up to 50 lbs.

Additional Duties:

• Wash sub-assemblies. Following SOPs and training, wash components in Steris parts washer. Perform visual inspection of components, maintain lot traceability of components, ensure all process documentation is completed correctly and concisely in electronic batch records. May perform some data entry as required.
• Glue sub-assemblies. Following SOPs and training, UV glue components together to create sub-assembly parts. Perform visual inspection of components, maintain lot traceability of components, ensure all process documentation is completed correctly and concisely in electronic batch records. 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.
• Must be computer literate and able to accurately enter data in electronic batch records, SAP, and nonconformance reports.

• 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
  • Ability to work overtime, including weekends
  • Must be able to lift up to 50 lbs routinely

What Repligen Offers

Our mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing. The estimated hourly rate/salary range for this role, based in the United States of America is $24.00/Hr. -$27.00/Hr. Compensation decisions are dependent on several factors including, but not limited to an individual's qualifications, location, internal equity, and alignment with market data. Additionally, employees are eligible to participate in one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits such as paid time off, health/dental/vision, retirement benefits and flexible spending accounts. All compensation and benefits information will be confirmed in writing at the time of offer.