Manufacturing Technician II - Sterile Filling

Resilience•West Chester, OH

About The Position

The Manufacturing Technician II reports to a Supervisor/Manager on the Manufacturing floor and supports Filling operations. The position works in Controlled/Non-Classified and Classified production areas, including cleanrooms, and requires aseptic gowning. The technician operates filling equipment; monitors processes; performs 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 pass an eye exam during onboarding. The role includes operating and sanitizing equipment, conducting in-process and finished-product checks, performing documentation and data-entry tasks, and supporting training, maintenance, validation, and process-improvement activities. Work follows the Quality Management System, applicable SOPs, cGMPs, and other relevant regulations and standards. The expected schedule at hire is a 12-hour 2/2/3 night shift. The company may change schedules and may request overtime based on business needs. Sponsorship or work-authorization support, including visas, is not available. The target base-pay range is $21.50–$32.00 per hour, with actual pay dependent on factors including location, experience, qualifications, skills, and knowledge.

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 involving 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 work in Controlled/Non-Classified and Classified production areas requiring aseptic gowning.
Ability to perform the physical demands of the role, including climbing, kneeling, standing, repetitive motion, and exerting up to 100 pounds of force to move objects.
Ability to handle potential exposure to area chemicals using precautions required by SOPs and use required personal protective equipment.
Participation in an occupational health program, which can include medical assessment, surveillance, vaccination, and testing.

Nice To Haves

High school, vocational school, or equivalent education.
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 in a lean manufacturing environment.
Working knowledge of Microsoft applications, SAP, and/or Veeva Vault.

Responsibilities

Operate assigned machinery, supply 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 under SOPs.
Start up equipment and make minor adjustments as needed.
Enter data online, including SCADA and HMI entries.
Work with printing devices, including printing mats.
Clean and maintain assigned areas to support a cGMP environment.
Perform visual and physical checks of in-process and finished materials as requested.
Follow aseptic behaviors and participate in media fills, including line interventions; maintain basic knowledge of viable and non-viable monitoring equipment.
Assist mechanical staff with preventive maintenance procedures as required.
Assist with validation and engineering protocols for processes and equipment.
Support lean and process-improvement activities, including 5S and problem-solving, and suggest improvements while maintaining quality and cGMP compliance.
Complete batch records and GMP documentation; maintain required records and logs, including mathematical computations when needed.
Perform limited inventory control and reconciliation activities using SAP.
Acquire and maintain required work-area certifications and qualifications, 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.