Manufacturing Technician II - Sterile Filling

Resilience•West Chester, OH

2d•$22 - $32

About The Position

The Manufacturing Technician II reports to a Supervisor/Manager on the Manufacturing floor and supports Filling operations. The role works in Controlled/Non-Classified and Classified production areas and requires aseptic gowning. The technician operates equipment, performs in-process monitoring, line clearances, OEE data collection, cosmetic inspection, cleaning, and batch record entries in accordance with cGMPs. Employees must demonstrate and maintain gown qualification standards and adhere to the applicable quality systems, procedures, and regulations.

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, including routine calculations such as weights, measures, and conversions.
Ability to follow written procedures and work instructions with minimal supervision and escalate issues as needed.
Basic problem-solving skills and ability to identify process or documentation deviations and inconsistencies.
Ability to work effectively as part of a team in a fast-paced production environment.
Ability to demonstrate and maintain gown qualification standards.
Ability to pass an eye exam during onboarding.
Ability to meet the physical and work-environment demands, including aseptic gowning, use of PPE, and handling potential exposure to area chemicals according to SOPs.

Nice To Haves

High school graduate, vocational school graduate, or equivalent.
At least 1 year of experience in pharmaceutical, biotechnology, or cGMP-regulated manufacturing.
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.

Responsibilities

Operate assigned machinery, service filling machines with materials, remove finished materials from machine tables, and maintain smooth product flow.
Assemble, disassemble, operate, and sanitize Filling equipment.
Perform filter integrity testing as needed according to SOPs.
Start up equipment and make minor adjustments as needed.
Enter required data online, including SCADA and HMI entries.
Work with printing devices, including printing mats.
Perform cleaning and housekeeping activities to maintain a cGMP environment.
Perform visual and physical checks of in-process and finished materials as requested.
Follow aseptic behaviors; participate in media fills, including line interventions; and 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, including 5S and problem-solving.
Identify and suggest process improvements while maintaining quality and cGMP compliance.
Complete batch record and GMP documentation entries, and maintain required records and logs, including mathematical computations where needed.
Perform inventory control and reconciliation activities using SAP in a limited role.
Acquire and maintain 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.
Adhere to the Quality Management System, Quality Manual, Quality Policy, SOPs, cGMPs, and other applicable regulations and standards.