Manufacturing Technician II - Filling (Nights)

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

The Manufacturing Technician II is a direct labor position reporting to a Process Execution Team (PET) Process Facilitator 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 completes batch record entries in accordance with cGMPs.

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 using 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.
• Ensure outgoing quality levels.
• 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.
• Adhere to SOPs, cGMPs, and safety procedures, including OSHA requirements and MSDS for area chemicals.
• Familiarize with job-related safety procedures (PPEs, ergonomics, LOTO, spill controls, etc.) and report discrepancies.
• Assist with preventive maintenance procedures.
• Support lean activities (5S, SMED, problem-solving, OEE 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.
• 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.
• Occasional overtime may be required with minimal advance notice.

Requirements

• Ability to effectively understand, read, write, communicate, and follow instructions in English.
• Strong attention to detail and ability to keep accurate records and perform mathematical calculations.
• Capability and 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.
• Some overtime may be required with minimal advance notice.

Qualifications

• Minimum:
  • High school graduate, vocational school graduate, or equivalent.
• Preferred:
  • Experience using an isolator.
  • Prior experience in a pharmaceutical or cGMP-regulated environment.
  • Good understanding and experience in aseptic process and technique.
  • Prior production experience in a Filling area.
  • Experience working in a LEAN manufacturing environment.
  • Knowledge of cGMPs and FDA policies/procedures.

Schedule

This opening is on a 12-hour night shift, operating on a 2-2-3 schedule (6:00 PM – 6:30 AM).

Pay

Our 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

• Robust total rewards program, including an 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.