Resilience
Manufacturing Technician II
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 Description
The Manufacturing Technician II is a direct labor position reporting to a Process Execution Team (PET) Manager on the Manufacturing floor, supporting Filling operations. This role will work in various Controlled/Non‑Classified and Classified areas. The Filling Technician operates equipment, performs in‑process monitoring, line clearances, OEE data collection, cosmetic inspection, cleaning and completes batch record entries in accordance with cGMPs. Job Responsibilities
Operate assigned machinery, servicing filling machines with materials, removing finished materials from machine tables, and assuring the smooth flow of product. Assemble, disassemble, operate and sanitize various Filling equipment. Perform filter integrity testing as needed per SOP. Perform cleaning and housekeeping activities for assigned areas to maintain a cGMP environment. Start up and make minor adjustments to machinery. Input data on SCADA and HMI systems. Perform visual and physical checks of in‑process and finished materials. Work with various printing devices, including printing mats. Create batch record and GMP documentation entries; maintain records and logs per job responsibilities, including mathematical computations where needed. Apply product security controls and handle material handling equipment. Maintain outgoing quality level. Understand aseptic behaviours, media fills, line interventions, and basic knowledge of viable and non‑viable monitoring equipment. Conduct inventory control and reconciliation activities, using SAP in a limited role. Perform duties in accordance with SOPs, cGMPs and safety procedures, including OSHA requirements, and be familiar with Material Safety Data Sheets. Follow safety procedures and hazards including PPE, ergonomics, LOTO, human safety, material handling, waste handling, chemical handling, and spill controls; report discrepancies to process facilitator. Assist mechanical staff with preventive maintenance procedures as required. Support lean activities and process improvement work such as performing 5S, Single Minute Exchange of Die (SMED), problem‑solving, and manual tracking of performance data for OEE and process improvement analysis. Assist with executing validation/engineering protocols for processes and equipment. Identify and provide suggestions for process improvement while maintaining quality and cGMP compliance. Be flexible in training and support other Filling functions as needed. Perform all other assigned duties with minimal supervision under the direction of the process facilitator or designee. Acquire and maintain all required certifications and qualifications for the assigned work area. Minimum Requirements
Ability to understand, read, write, communicate and follow instructions in the English language. Good attention to detail; capable of keeping accurate records and performing mathematical calculations. Capable and motivated to learn new skills and develop new capabilities on an ongoing basis. Ability to work effectively in a team environment. Adaptability to a changing and demanding environment. Some overtime may be required with minimal advance notice to support business needs. Preferred Requirements
High school graduate, vocational school graduate or equivalent. 1 year of experience in a pharmaceutical or cGMP regulated environment. Prior production experience. Experience working in a LEAN manufacturing environment. Knowledge of cGMPs and FDA policies/procedures. Sponsorship or support for work authorization, including visas, is not available for this position. Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non‑job‑related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process. Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and benefits designed to support healthcare, family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and caregiving support. Our target base pay hiring range for this position is $21.50 - $32.00 per hour. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.
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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 Description
The Manufacturing Technician II is a direct labor position reporting to a Process Execution Team (PET) Manager on the Manufacturing floor, supporting Filling operations. This role will work in various Controlled/Non‑Classified and Classified areas. The Filling Technician operates equipment, performs in‑process monitoring, line clearances, OEE data collection, cosmetic inspection, cleaning and completes batch record entries in accordance with cGMPs. Job Responsibilities
Operate assigned machinery, servicing filling machines with materials, removing finished materials from machine tables, and assuring the smooth flow of product. Assemble, disassemble, operate and sanitize various Filling equipment. Perform filter integrity testing as needed per SOP. Perform cleaning and housekeeping activities for assigned areas to maintain a cGMP environment. Start up and make minor adjustments to machinery. Input data on SCADA and HMI systems. Perform visual and physical checks of in‑process and finished materials. Work with various printing devices, including printing mats. Create batch record and GMP documentation entries; maintain records and logs per job responsibilities, including mathematical computations where needed. Apply product security controls and handle material handling equipment. Maintain outgoing quality level. Understand aseptic behaviours, media fills, line interventions, and basic knowledge of viable and non‑viable monitoring equipment. Conduct inventory control and reconciliation activities, using SAP in a limited role. Perform duties in accordance with SOPs, cGMPs and safety procedures, including OSHA requirements, and be familiar with Material Safety Data Sheets. Follow safety procedures and hazards including PPE, ergonomics, LOTO, human safety, material handling, waste handling, chemical handling, and spill controls; report discrepancies to process facilitator. Assist mechanical staff with preventive maintenance procedures as required. Support lean activities and process improvement work such as performing 5S, Single Minute Exchange of Die (SMED), problem‑solving, and manual tracking of performance data for OEE and process improvement analysis. Assist with executing validation/engineering protocols for processes and equipment. Identify and provide suggestions for process improvement while maintaining quality and cGMP compliance. Be flexible in training and support other Filling functions as needed. Perform all other assigned duties with minimal supervision under the direction of the process facilitator or designee. Acquire and maintain all required certifications and qualifications for the assigned work area. Minimum Requirements
Ability to understand, read, write, communicate and follow instructions in the English language. Good attention to detail; capable of keeping accurate records and performing mathematical calculations. Capable and motivated to learn new skills and develop new capabilities on an ongoing basis. Ability to work effectively in a team environment. Adaptability to a changing and demanding environment. Some overtime may be required with minimal advance notice to support business needs. Preferred Requirements
High school graduate, vocational school graduate or equivalent. 1 year of experience in a pharmaceutical or cGMP regulated environment. Prior production experience. Experience working in a LEAN manufacturing environment. Knowledge of cGMPs and FDA policies/procedures. Sponsorship or support for work authorization, including visas, is not available for this position. Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non‑job‑related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process. Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and benefits designed to support healthcare, family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and caregiving support. Our target base pay hiring range for this position is $21.50 - $32.00 per hour. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.
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