Manufacturing Technician III - Sterile Filling (Nights)

Resilience; Port Union (OH); Sur place; USD 52 000 - 79 000; Plein temps

Avantages offerts par ce poste

Annual cash bonus

401(k) with company match

Medical, dental, and vision coverage

Paid vacation and holidays

Résumé du poste

Resilience in Ohio is seeking a Manufacturing Technician III to operate filling equipment, perform aseptic technique, and monitor in-process materials on the manufacturing floor. You will work in controlled areas, complete batch records, train Tech II team members, and support lean initiatives while maintaining cGMP compliance.

The role requires English proficiency, attention to detail, and the ability to work in a fast-paced team with a commitment to quality and safety.

Qualifications

• Progressive experience in pharma/biotech or cGMP manufacturing with independent filling procedures.
• Strong knowledge of cGMP regulations, deviation reporting, change control, and data integrity.
• Ability to read, write, and communicate technically in English with cross-functional teams.

Responsabilités

• Operate filling machinery, service equipment, and ensure smooth product flow.
• Perform aseptic techniques, line interventions, and environmental monitoring activities.
• Complete batch records and GMP documentation with accuracy.
• Train and evaluate Tech II team members; participate in daily tier meetings.
• Support lean initiatives and participate in problem-solving and 5S activities.
• Execute SAP transactions at an intermediate level and maintain data integrity.

Connaissances

Aseptic technique

cGMP compliance

Equipment operation

Mentoring Tech II

Lean / process improvement

English communication

Problem solving

Data entry & SAP

Formation

High school diploma or equivalent

Technical/Vocational training

Outils

SAP

Veeva Vault

Microsoft Office

Description du poste

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

The Manufacturing Technician III reports to a Supervisor/Manager on the Manufacturing floor, supporting Filling (Sterile) operations. This position requires working in Controlled/Non-Classified and Classified areas. The Technician independently operates filling equipment, demonstrates advanced aseptic technique, performs in-process monitoring, and mentors Tech II team members.

Job Responsibilities

Operations

• Independently perform the duties of operating all 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.

• Demonstrate advanced aseptic technique; lead and participate in media fills, including line interventions; apply working knowledge of viable and non-viable environmental monitoring.

• 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.

• Perform SAP transactions as required at an intermediate level of knowledge.

Documentation & Compliance

• Complete batch record and GMP documentation entries; independently review own documentation for accuracy before submission.

• Identify and provide suggestions for process improvement while maintaining quality and cGMP compliance.

Training & Development

• Act as a certified OJT trainer on assigned equipment and process tasks; train and evaluate Tech II team members.

• Maintain all required certifications and qualifications for the assigned work area.

• Cross-train and support other work areas as needed.

• Attend and actively participate in daily tier meetings.

Experience & Education

Minimum Qualifications

• Progressive experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment, including independent execution of filling procedures.

• Strong working knowledge of cGMP regulations, including deviation reporting, change control, and data integrity principles.

• Proven ability to independently execute complex procedures and troubleshoot routine process or equipment issues.

• Ability to effectively read, write, speak, and understand English to interpret technical documents and clearly communicate cross-functionally.

• High level of attention to detail with demonstrated accuracy in completing and reviewing batch records and controlled documentation.

• Proficient mathematical and analytical skills, including performing calculations related to manufacturing processes and verifying results.

• Experience mentoring or training technicians and supporting onboarding of new team members.

• Ability to identify process improvements and contribute to continuous improvement initiatives.

• Strong organizational skills and the ability to prioritize tasks while maintaining compliance and production timelines.

• 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.

• 2+ years of experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment.

• Prior aseptic manufacturing experience.

• 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 $24.00 - $38.00 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.

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.