BioSpace
Manufacturing Technician III, Sterile Filling (Night Shift)
BioSpace, West Chester, Ohio, United States
Overview
1 day ago Be among the first 25 applicants A career at Resilience is more than just a job – it’s an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com Job Summary
The Manufacturing Technician III reports to the Supervisor/Manager of Manufacturing on the Manufacturing floor, which supports Sterile operations. This position will require working in various Controlled/Non-Classified and Classified areas; operates equipment, performs in-process monitoring, line clearances, OEE data collection, cosmetic inspection, cleaning, and completes batch record entries in accordance with cGMPs. Night Shift
Night Shift position working 6pm–6:30am on a 2-2-3 rotational schedule Responsibilities
Operate assigned machinery, including servicing filling machines with materials, removing finished materials from machine tables, and ensuring smooth product flow Assemble, disassemble, operate, and sanitize various filling equipment Perform and execute filter integrity testing as needed per SOP Perform cleaning and housekeeping activities to maintain a cGMP environment Start up and make minor adjustments to machinery Input data into computer systems as required (SCADA and HMI entries) Perform visual and physical checks of in-process and finished materials Work with printing devices including printing mats Complete batch record and GMP documentation entries; maintain records/logs Understand product security controls and material handling equipment Maintain outgoing quality level and adhere to aseptic practices including media fills and line interventions Knowledge of viable and non-viable monitoring equipment Perform inventory control and reconciliation, may use SAP in a limited role Follow SOPs, cGMPs, and OSHA safety procedures; be familiar with MSDS Support preventive maintenance and lean activities (5S, SMED); participate in problem-solving and process improvement; track performance data for OEE Assist with validating processes/equipment and with creating continuous improvement suggestions Be flexible in training and support other Filling functions as needed Work with minimal supervision under the direction of the process facilitator or designee Acquire and maintain required certifications for the assigned work area Learn new skills and contribute to the Process Execution Team Work effectively in a team and adapt to changing/demanding environments Overtime may be required with minimal advance notice Minimum Qualifications
Significant experience in a pharmaceutical and/or cGMP regulated environment Ability to read, write, communicate and follow instructions in English Good attention to detail; capable of keeping accurate records and performing mathematical calculations Preferred Qualifications
High school diploma, vocational training, or equivalent Prior production experience Prior aseptic manufacturing experience Experience in LEAN manufacturing Knowledge of cGMPs and FDA policies/procedures Equal Employment Opportunity
Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, marital status, protected veteran status, disability status, or other non-job-related characteristics as per applicable laws. Requests for reasonable accommodation can be made at any stage of the recruitment process. Compensation and Benefits
Resilience offers a robust total rewards program including an annual cash bonus, a 401(k) with company match, medical/dental/vision coverage, family building benefits, life and disability insurance, flexible time off, paid holidays, tuition reimbursement, and caregiver support. Target base pay range for this position is $24.00 - $36.50 per hour. Actual base pay depends on various factors including location and experience. Excited about Resilience and the biomanufacturing revolution? Apply and start a conversation with a recruiter.
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1 day ago Be among the first 25 applicants A career at Resilience is more than just a job – it’s an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com Job Summary
The Manufacturing Technician III reports to the Supervisor/Manager of Manufacturing on the Manufacturing floor, which supports Sterile operations. This position will require working in various Controlled/Non-Classified and Classified areas; operates equipment, performs in-process monitoring, line clearances, OEE data collection, cosmetic inspection, cleaning, and completes batch record entries in accordance with cGMPs. Night Shift
Night Shift position working 6pm–6:30am on a 2-2-3 rotational schedule Responsibilities
Operate assigned machinery, including servicing filling machines with materials, removing finished materials from machine tables, and ensuring smooth product flow Assemble, disassemble, operate, and sanitize various filling equipment Perform and execute filter integrity testing as needed per SOP Perform cleaning and housekeeping activities to maintain a cGMP environment Start up and make minor adjustments to machinery Input data into computer systems as required (SCADA and HMI entries) Perform visual and physical checks of in-process and finished materials Work with printing devices including printing mats Complete batch record and GMP documentation entries; maintain records/logs Understand product security controls and material handling equipment Maintain outgoing quality level and adhere to aseptic practices including media fills and line interventions Knowledge of viable and non-viable monitoring equipment Perform inventory control and reconciliation, may use SAP in a limited role Follow SOPs, cGMPs, and OSHA safety procedures; be familiar with MSDS Support preventive maintenance and lean activities (5S, SMED); participate in problem-solving and process improvement; track performance data for OEE Assist with validating processes/equipment and with creating continuous improvement suggestions Be flexible in training and support other Filling functions as needed Work with minimal supervision under the direction of the process facilitator or designee Acquire and maintain required certifications for the assigned work area Learn new skills and contribute to the Process Execution Team Work effectively in a team and adapt to changing/demanding environments Overtime may be required with minimal advance notice Minimum Qualifications
Significant experience in a pharmaceutical and/or cGMP regulated environment Ability to read, write, communicate and follow instructions in English Good attention to detail; capable of keeping accurate records and performing mathematical calculations Preferred Qualifications
High school diploma, vocational training, or equivalent Prior production experience Prior aseptic manufacturing experience Experience in LEAN manufacturing Knowledge of cGMPs and FDA policies/procedures Equal Employment Opportunity
Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, marital status, protected veteran status, disability status, or other non-job-related characteristics as per applicable laws. Requests for reasonable accommodation can be made at any stage of the recruitment process. Compensation and Benefits
Resilience offers a robust total rewards program including an annual cash bonus, a 401(k) with company match, medical/dental/vision coverage, family building benefits, life and disability insurance, flexible time off, paid holidays, tuition reimbursement, and caregiver support. Target base pay range for this position is $24.00 - $36.50 per hour. Actual base pay depends on various factors including location and experience. Excited about Resilience and the biomanufacturing revolution? Apply and start a conversation with a recruiter.
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