Manufacturing Technician III - Sterile Filling (Day Shift)

Resilience•West Chester, OH

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 production areas and requires aseptic gowning. The technician independently operates filling equipment, demonstrates advanced aseptic technique, performs in-process monitoring, and mentors Technician II team members. The position includes operating, assembling, disassembling, and sanitizing filling equipment; performing filter integrity testing; completing equipment start-ups and minor adjustments; entering data in systems such as SCADA and HMI; and maintaining a cGMP environment. The technician performs visual and physical checks, participates in media fills and environmental monitoring, supports maintenance and validation activities, and contributes to lean and process-improvement work. The role also includes completing and reviewing batch records and GMP documentation, training and evaluating Technician II team members, maintaining required qualifications, and cross-training as needed. The work is primarily non-sedentary and takes place in production and cleanroom areas. It can involve climbing, kneeling, standing, repetitive motion, temperature changes, moving objects requiring up to 100 pounds of force, and potential exposure to chemicals. Employees may need to use PPE such as respirators, PAPRs, gowns, gloves, and face protection, and must participate in an occupational health program and pass an eye exam during onboarding. The listed schedule is a 12-hour 2/2/3 night shift; schedules may be changed and overtime may be requested based on business needs. The position does not offer work-authorization or visa sponsorship.

Requirements

Progressive experience in pharmaceutical, biotechnology, or cGMP-regulated manufacturing, including independent execution of 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 to interpret technical documents and communicate across functions.
Strong attention to detail and demonstrated accuracy in completing and reviewing batch records and controlled documentation.
Proficient mathematical and analytical skills, including performing manufacturing 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 and prioritization skills while maintaining compliance and production timelines.
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 described, including working in classified areas, aseptic gowning, and use of required PPE.

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 filling machinery, supply materials, remove finished materials, and maintain smooth product flow.
Assemble, disassemble, operate, and sanitize filling equipment.
Perform filter integrity testing as required by SOP.
Start up equipment and make minor adjustments as needed.
Enter data online, including SCADA and HMI entries, and perform SAP transactions at an intermediate level.
Work with printing devices, including printing mats.
Perform cleaning and housekeeping to maintain cGMP conditions in assigned areas.
Perform 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 knowledge of viable and non-viable environmental monitoring.
Assist mechanical staff with preventive maintenance and help execute validation and engineering protocols for processes and equipment.
Support lean and process-improvement activities, including 5S and problem-solving.
Complete batch records and GMP documentation, and independently review entries for accuracy before submission.
Identify and suggest process improvements while maintaining quality and cGMP compliance.
Act as a certified OJT trainer for assigned equipment and tasks; train and evaluate Technician II team members.
Maintain required certifications and qualifications, cross-train and support other work areas, and participate in daily tier meetings.