Manufacturing Technician III - Sterile Filling

Resilience•West Chester, OH

23h

About The Position

The Manufacturing Technician III reports to a Supervisor/Manager on the Manufacturing floor and supports sterile filling operations. The role works in Controlled/Non-Classified and Classified areas and independently operates filling equipment, demonstrates advanced aseptic technique, performs in-process monitoring, and mentors Technician II team members. Employees must demonstrate and maintain gown qualification standards and adhere to applicable quality systems, SOPs, cGMP requirements, and other regulations and standards.

Requirements

Progressive experience in pharmaceutical, biotechnology, or cGMP-regulated manufacturing, including independently executing filling procedures.
Strong working knowledge of cGMP regulations, including deviation reporting, change control, and data integrity principles.
Ability to independently execute complex procedures and troubleshoot routine process or equipment issues.
Ability to read, write, speak, and understand English well enough to interpret technical documents and communicate clearly across functions.
High attention to detail and demonstrated accuracy completing and reviewing batch records and controlled documentation.
Proficient mathematical and analytical skills, including performing manufacturing-process calculations and verifying results.
Experience mentoring or training technicians and supporting onboarding of new team members.
Ability to identify process improvements and contribute to continuous improvement initiatives.
Strong organizational skills and ability to prioritize tasks while maintaining compliance and production timelines.
Ability to work effectively as part of a team in a fast-paced production environment.
Ability to pass an eye exam during onboarding.
Ability to demonstrate and maintain gown qualification standards.
Ability to work in production areas requiring aseptic gowning and use required personal protective equipment.
Ability to meet the physical demands of the role, including climbing, kneeling, standing, repetitive motion, working through temperature changes, and exerting up to 100 pounds of force to move objects.
Ability to handle potential exposure to area chemicals using precautions specified in SOPs.
Participation in an occupational health program, which may include medical assessment, surveillance, vaccination, and testing.

Nice To Haves

High school graduate, vocational school graduate, or equivalent.
Two or more years of experience in pharmaceutical, biotechnology, or cGMP-regulated manufacturing.
Prior aseptic manufacturing experience.
Experience working in a lean manufacturing environment.
Working knowledge of Microsoft applications, SAP, and/or Veeva Vault.

Responsibilities

Independently 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 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 requested visual and physical checks of in-process and finished materials.
Demonstrate advanced aseptic technique; lead and participate in media fills, including line interventions; and apply working knowledge of viable and non-viable environmental monitoring.
Assist mechanical staff with preventive maintenance procedures as required.
Assist with executing validation and engineering protocols for processes and equipment.
Support lean activities and process improvement work, including 5S and problem-solving.
Perform SAP transactions at an intermediate level of knowledge as required.
Complete batch records and GMP documentation, and independently review documentation for accuracy before submission.
Identify and suggest process improvements while maintaining quality and cGMP compliance.
Act as a certified OJT trainer on assigned equipment and process tasks; train and evaluate Technician II team members.
Maintain required certifications and qualifications for the assigned work area.
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.