Manufacturing Technician II, Filling

Resilience is a technology-focused biomanufacturing company 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.

About the role

This is a direct labor position reporting to a Process Execution Team (PET) Process Facilitator on the Manufacturing floor, supporting Filling operations. 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. This role requires working in various Controlled/Non-Classified and Classified areas.

These openings are on a 12-hour day shift or night shift, operating on a 2-2-3 schedule (6am - 6:30pm or 6pm - 6:30am).

Responsibilities

• Operate assigned machinery, including servicing filling machines with materials, removing finished materials, and ensuring smooth product flow.
• Assemble, disassemble, operate, and sanitize various Filling equipment.
• Perform and execute filter integrity testing as needed per SOP.
• Conduct cleaning and housekeeping activities to maintain a cGMP environment.
• Start up machinery and make minor adjustments as required.
• Perform data input in SCADA and HMI systems.
• Conduct visual and physical checks of in-process and finished materials.
• Operate various printing devices, including printing mats.
• Complete batch record and GMP documentation entries, including mathematical computations.
• Maintain records and logs as required.
• Understand product security controls and material handling equipment.
• Maintain outgoing quality level standards.
• Demonstrate knowledge of aseptic behaviors, media fills (including line interventions), and viable/non-viable monitoring equipment.
• Perform inventory control and reconciliation activities, potentially using SAP/WES in a limited role.
• Adhere to SOPs, cGMPs, and established safety procedures (OSHA requirements), including familiarity with Material Safety Data Sheets for area chemicals.
• Follow job-related safety procedures, including PPE, ergonomics, LOTO, human safety, material handling, waste handling, chemical handling, and spill controls.
• Report all discrepancies to the process facilitator.
• Assist mechanical staff with preventive maintenance procedures.
• Support lean activities and process improvement initiatives (e.g., 5S, SMED, problem-solving, OEE data tracking).
• Assist with executing Validation/Engineering protocols for processes/equipment.
• Identify and suggest process improvements while maintaining quality and cGMP compliance.
• Train and support other Filling functions as needed.
• Perform all 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.
• Work effectively in a team environment and adapt to a changing/demanding environment.
• Some overtime may be required with minimal advance notice to support business needs.

Requirements

• Ability to effectively understand, read, write, communicate, and follow instructions in English.
• Strong attention to detail and capability to keep accurate records and perform mathematical calculations.
• Motivation to learn new skills and develop capabilities continuously.
• Ability to work effectively in a team environment.
• Ability to adapt to a changing and demanding work environment.
• Willingness to work overtime with minimal advance notice.

Preferred Qualifications

• High school diploma, vocational school diploma, or equivalent.
• Prior experience using an isolator.
• Experience in a pharmaceutical or cGMP-regulated environment.
• Understanding and experience in aseptic processes and techniques.
• Prior production experience, particularly in a Filling area.
• Experience working in a LEAN manufacturing environment.
• Knowledge of cGMPs and FDA policies/procedures.

Pay

Target base pay hiring range for this position is $21.50 - $32.00 per hour. Actual base pay depends on geographical location, relevant experience, qualifications, skills, and knowledge.

Benefits

Resilience offers a robust total rewards program, including:

• Annual cash bonus program.
• 401(k) plan with a generous company match.
• Comprehensive healthcare benefits (medical, dental, and vision).
• Family-building benefits.
• Life and disability insurance.
• Paid vacation, holidays, and other leaves of absence.
• Tuition reimbursement.
• Support for caregiving needs.

As a requirement of this role, employees must demonstrate and maintain gown qualification standards for specific areas of Sterile Operations.