Manufacturing Associate I

Repligen Corporation; Marlborough (MA); On-site; USD 35,000 - 55,000; Full time

Job summary

An established industry player is seeking a Manufacturing Associate I to join their dynamic team. This entry-level role involves performing essential activities in the production of tangential flow filtration cassettes, ensuring the highest quality standards are met. The ideal candidate will possess strong problem-solving skills and attention to detail, be able to lift up to 50 lbs, and thrive in a fast-paced environment. With opportunities for cross-training and growth, this position is perfect for someone eager to learn and contribute to a collaborative team focused on excellence in manufacturing.

Qualifications

• Must be able to follow oral and written instructions accurately.
• Experience in a classified cleanroom and knowledge of GMP/ISO processes are beneficial.

Responsibilities

• Assembly of cassette components ensuring quality and quantity.
• Final inspection and packaging of finished products in controlled environments.

Skills

Problem-solving skills

Attention to detail

Manual dexterity

Computer literacy

Ability to follow instructions

Education

High school diploma or equivalent

Tools

MS Office

SAP

Job description

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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 and some frequent lifting up to 50 lbs. The candidate will actively follow Repligen ISO 9001 Quality Management System in support of manufacturing processes and product testing. Experience working in a classified cleanroom and knowledge of GMP/ISO/document-controlled processes are beneficial. Attention to detail and teamwork are essential. Good hand-eye coordination and manual dexterity are required. The candidate must be computer literate with some MS Office experience.

Responsibilities

Essential Duties:

1. Assembly of cassette components following SOPs and training, ensuring quality and quantity. This includes operation of trimming equipment, manual assembly, visual inspection, and proper documentation. Ensure tooling is clean and functional.
2. Encapsulation of components, using process equipment and tooling according to SOPs and documentation. Mixing components and working with chemicals are involved.

Additional Duties:

1. Assembly and visual inspection of single-use devices and hardware, following drawings/Bill of Materials, in controlled environments. Proper documentation and data entry as required.
2. Die cutting of cassette components using process equipment, with visual inspection and proper documentation.
3. Final inspection and packaging of finished products, including visual inspection, packaging in controlled environments, and documentation.

Other Functions

• Maintain workspace and tooling cleanliness.
• Coordinate with QA and production to ensure flow and identify non-conforming products.
• Meet established short-term and long-term goals.
• Assist in training new hires on procedures.
• Follow instructions, learn new processes, and work overtime as needed, including weekends.

Qualifications

• High school diploma or equivalent.
• Computer literacy, preferably with MS Office and SAP.
• Ability to work independently after training.
• High attention to detail and organizational skills.
• Resourceful, self-motivated, and efficient in a fast-paced environment.
• Ability to work within an ISO-9001 quality system with attention to controlled procedures.
• Ability to lift up to 50 lbs routinely.
• Willing to work overtime, including weekends.

Additional Information

• Seniority level: Entry level
• Employment type: Full-time
• Job function: Research, Analysis, and Information Technology