Manufacturing Technician II - Sterile Filling (Day Shift)

Resilience; Northern (KY); Hybride; USD 61 606 000 - 91 693 000; Plein temps

Avantages offerts par ce poste

401(k) matching

Health, dental, vision

Annual bonus program

Résumé du poste

Resilience in West Chester, OH is seeking a Manufacturing Technician II - Sterile Filling (Day Shift) to operate filling lines, perform line clearances, and enter batch data in SAP/HMI while maintaining aseptic conditions in a cGMP environment. The role requires reading SOPs, attention to detail, and strong teamwork in a fast-paced, regulated setting.

Prior pharma/biotech experience is preferred; on-the-job training and gowning certification will be provided.

Qualifications

• Experience in a regulated manufacturing environment preferred.
• Ability to read, write and understand English SOPs and batch records.
• Basic math and data entry skills with strong attention to detail.

Responsabilités

• Operate filling machines and service lines to ensure smooth product flow.
• Assemble, disassemble, sanitize equipment and perform line clearances.
• Enter batch data online (SAP/HMI) and maintain cGMP documentation.
• Support lean activities and maintain a clean, compliant work area.
• Assist with validation, maintenance, and quality checks as needed.

Connaissances

Aseptic gowning

Data entry

Batch records

SAP

Lean manufacturing

Teamwork

Attention to detail

Formation

High school diploma or equivalent

Outils

SCADA

HMI

Veeva Vault

Description du poste

## Manufacturing Technician II - Sterile Filling (Day Shift)Apply: USA - OH - West Chester: Full time: Posted Today: R-107218A 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.comThe Manufacturing Technician II reports to a Supervisor/Manager on the Manufacturing floor, supporting Filling operations. This position requires working 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 batch record entries in accordance with cGMPs.# **Job Responsibilities****Operations*** Perform the duties of operating assigned machinery: servicing filling machines with materials, removing finished materials from machine tables, and assuring smooth product flow.* Assemble, disassemble, operate, and sanitize various Filling equipment.* Perform and execute filter integrity testing as needed per SOP.* Start-up equipment and make minor adjustments as needed.* Enter data online as required, including SCADA and HMI entries.* Work with various printing devices, including printing mats.* Perform cleaning and housekeeping activities for assigned areas as required to maintain a cGMP environment.* Perform visual and physical checks of in-process and finished materials as requested.* Understand aseptic behaviors; participate in media fills, including line interventions; maintain basic knowledge of viable and non-viable monitoring equipment.* Assist mechanical staff with preventive maintenance procedures, as required.* Assist with executing Validation/Engineering protocols for processes and equipment.* Support lean activities and process improvement work, such as performing 5S and participating in problem-solving.* Identify and provide suggestions for process improvement while maintaining quality and cGMP compliance.**Documentation & Compliance*** Perform batch record and GMP documentation entries; maintain records and logs as required, including mathematical computation where needed.* Perform inventory control and reconciliation activities using SAP in a limited role.**Training & Development*** Acquire and maintain all required certifications and qualifications for the assigned work area, including aseptic gowning qualification.* Cross-train and support other work areas as needed.* Attend and actively participate in daily tier meetings.# # Education & Experience**Minimum Qualifications*** Prior experience in a regulated manufacturing environment.* Ability to effectively read, write, speak, and understand English to interpret SOPs, batch records, and work instructions.* Demonstrated documentation and data entry skills, including accurate completion of batch records and logbooks.* Basic mathematical skills, including the ability to perform routine calculations (e.g., weights, measures, conversions).* Ability to follow written procedures and work instructions with minimal supervision, escalating issues as needed.* Basic problem-solving skills and the ability to identify deviations or inconsistencies in processes or documentation.* Ability to work effectively as part of a team in a fast-paced production environment.**Preferred Qualifications*** High school graduate, vocational school graduate, or equivalent.* 1+ years of experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment.* Working knowledge of cGMP principles, including documentation practices, safety procedures, and compliance expectations.* Experience working in a lean manufacturing environment.* Working knowledge of Microsoft applications, SAP and/or Veeva Vault.# # **Physical & Work Environment*** Work is performed in Controlled/Non-Classified and Classified (cleanroom) production areas requiring aseptic gowning. This is primarily a non-Sedentary role that can include climbing, kneeling, standing, repetitive motion, temperature changes, exerting up to 100 pounds of force to move objects, and potential exposure to area chemicals requiring handling precautions per SOP.* Visual acuity such as working with data & figures, viewing computer terminal, extensive reading, operating machinery, operating motor vehicles, general observations of facilities, etc.* Participation in an occupational health program, which can include medical assessment, surveillance, vaccination, and testing.* Use of personal protective equipment, which can include respirators, Personal Air Purifying Respirators [PAPR], gowns, gloves, face protection, other barrier equipment, etc.* All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role. * Ability to pass eye exam during onboarding.# **Work Schedule**[examples: 8 hours - Monday- Friday; 10 hours – Monday-Thursday; 12 hour – 2/2/3] The work schedule listed reflects the employee’s expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, including a request to work overtime, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments.***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 our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. 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? We encourage you to apply and start a conversation with one of our recruiters.*As a requirement of this role, employees must have the ability to* *demonstrate and maintain gown qualification standards. Please review the video below, which outlines the most extensive process to gown within specific areas of Sterile Operations at Resilience, West Chester.*