Manufacturing Technician II, Device Assembly (Nights)

BioSpace; Olde West Chester (OH); On-site; USD 60,000 - 80,000; Full time

Job summary

An established industry player is seeking a dedicated Manufacturing Technician II for its night shift operations. This role involves crucial tasks such as operating machinery, performing quality inspections, and ensuring compliance with cGMP standards. The ideal candidate will thrive in a fast-paced environment, supporting lean activities and process improvements. With a focus on teamwork and adaptability, this position offers a unique opportunity to contribute to the biomanufacturing revolution while enjoying a comprehensive rewards program that includes equity, bonuses, and flexible time off. If you are passionate about quality and efficiency, this role is perfect for you.

Benefits

Equity

401(k) matching

Healthcare benefits

Flexible time off

Paid holidays

Tuition reimbursement

Caregiving support

Qualifications

• Experience in a pharmaceutical or cGMP environment is required.
• Ability to communicate effectively in English is essential.

Responsibilities

• Operate machinery and monitor equipment status to ensure smooth workflow.
• Perform visual quality inspections and document batch records.

Skills

Attention to detail

Record-keeping

Mathematical skills

Problem-solving

Teamwork

Education

High school diploma or equivalent

Vocational training

Tools

Microsoft Office

SAP

LEAN manufacturing principles

Job description

Manufacturing Technician II, Device Assembly (Nights)

Join to apply for the Manufacturing Technician II, Device Assembly (Nights) role at BioSpace.

This position involves working in various Controlled/Non-Classified areas, performing manufacturing tasks such as operating equipment, monitoring processes, line clearances, cosmetic inspections, cleaning, and completing batch records. It also includes supporting improvement activities like 5S, problem-solving, and Kaizen events to ensure product quality and consistency in accordance with cGMPs.

Responsibilities include:

• Operating machinery, servicing materials, monitoring equipment status, reintroducing materials, palletizing finished products, and ensuring smooth workflow.
• Starting up machinery, performing recipe selection, data entry, making minor adjustments, and handling critical sensor challenges.
• Manual packaging and rework of in-process and finished materials.
• Using light material handling equipment safely.
• Performing visual quality inspections and sampling, escalating concerns as needed.
• Troubleshooting minor equipment issues and collaborating with technical teams for resolution.
• Managing inventory control and reconciliation, possibly using SAP and WES.
• Maintaining cleanliness, sanitation, and line clearance to uphold cGMP standards.
• Documenting batch records and performing mathematical calculations as required.
• Adhering to safety procedures, PPE use, ergonomics, LOTO, and reporting discrepancies.
• Supporting lean activities, process improvements, and manual data tracking for performance analysis.
• Acting as a certified OJT trainer, conducting evaluations, and reviewing process documentation.
• Executing protocols related to equipment qualification and process validation.
• Flexibility to support other manufacturing areas and acquire necessary certifications.
• Working effectively in a team, adapting to changing environments, and supporting overtime as needed.

Minimum Qualifications:

• Experience in a pharmaceutical or cGMP environment.
• Ability to read, write, communicate, and follow instructions in English.
• Attention to detail, record-keeping, and mathematical skills.

Preferred Qualifications:

• High school diploma, vocational training, or equivalent.
• Knowledge of Microsoft Office and SAP.
• Previous production experience and familiarity with LEAN manufacturing, cGMPs, and FDA policies.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will be considered without regard to protected characteristics. Reasonable accommodations are available upon request.

Resilience offers a comprehensive rewards program, including equity, bonuses, 401(k) matching, healthcare, family benefits, life and disability insurance, flexible time off, paid holidays, tuition reimbursement, and caregiving support. The pay range is $21.50 - $32.00 per hour, depending on various factors.

We encourage you to apply and start a conversation with our recruiters if you're excited about contributing to the biomanufacturing revolution.