Manufacturing Technician II - Sterile Filling
About the role
Resilience is a technology-focused biomanufacturing company changing how medicine is made by building a sustainable network of high-tech, end-to-end manufacturing solutions to withstand disruptive events, enable scientific discovery, and reach those in need. The Manufacturing Technician II supports Filling operations on the manufacturing floor under the direction of a Supervisor/Manager, including work in Controlled/Non-Classified and Classified areas.
Responsibilities
- Operate filling machines: service with materials, remove finished materials, and ensure smooth product flow
- Assemble, disassemble, operate, and sanitize filling equipment
- Perform filter integrity testing as required by SOP
- Start up equipment and make minor adjustments as needed
- Enter data online (SCADA, HMI) and operate various printing devices
- Maintain cGMP-compliant cleaning and housekeeping in assigned areas
- Perform visual and physical checks of in-process and finished materials
- Practice aseptic behaviors; participate in media fills and line interventions; maintain basic knowledge of viable and non-viable monitoring equipment
- Assist mechanical staff with preventive maintenance procedures
- Support execution of validation/engineering protocols for processes and equipment
- Participate in lean activities and process improvement efforts such as 5S and problem-solving
- Identify and suggest process improvements while maintaining quality and cGMP compliance
- Complete batch records and GMP documentation; maintain required records and logs, including mathematical computations
- Perform limited inventory control and reconciliation activities using SAP
- Acquire and maintain required certifications and qualifications, including aseptic gowning qualification
- Cross-train and support other work areas as needed
- Attend and actively participate in daily tier meetings
Requirements
- Prior experience in a regulated manufacturing environment
- Ability to 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 for routine calculations (weights, measures, conversions)
- Ability to follow written procedures and work instructions with minimal supervision, escalating issues as needed
- Basic problem-solving skills and ability to identify deviations or inconsistencies
- 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 pharmaceutical, biotechnology, or cGMP-regulated manufacturing
- Working knowledge of cGMP principles, documentation practices, safety procedures, and compliance expectations
- Experience 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
- Primarily a non-sedentary role involving climbing, kneeling, standing, repetitive motion, temperature changes, and exerting up to 100 pounds of force to move objects
- Potential exposure to area chemicals requiring handling precautions per SOP
- Visual acuity for data & figures, computer terminals, extensive reading, operating machinery, and general facility observations
- Participation in an occupational health program (medical assessment, surveillance, vaccination, testing)
- Use of personal protective equipment including respirators, PAPRs, gowns, gloves, face protection, and other barrier equipment
- Ability to pass eye exam during onboarding
- Must be able to demonstrate and maintain gown qualification standards
Pay
The target base pay hiring range for this position is $21.50 – $32.00 per hour. Actual base pay is dependent on factors including geographical location, relevant experience, qualifications, skills, and knowledge.
Schedule
12-hour, 2/2/3 night shift schedule. The Company may modify work schedules at any time based on business needs.