Manufacturing Technician II - DAP

Resilience•West Chester, OH

27d

About The Position

The Manufacturing Technician II reports to a Supervisor/Manager, Manufacturing and performs manufacturing tasks in controlled and non-classified areas in accordance with cGMPs, supporting packaging operations. The role involves operating packaging equipment, in-process monitoring, line clearances, cosmetic inspection, cleaning, and completing batch record entries. The technician operates and sets up machinery, performs manual packaging and rework, moves materials using light material-handling equipment, inspects and samples in-process materials, conducts minor troubleshooting, and supports inventory control. The role also includes cleaning and housekeeping, GMP documentation, safety compliance, lean and process improvement activities, and participation in equipment qualification and process validation protocols. The technician provides flexible support to other manufacturing areas, maintains required certifications and qualifications, and attends daily Tier 0 meetings. This is a primarily non-sedentary role involving physical activity such as climbing, kneeling, repetitive motion, exposure to temperature changes, and exerting up to 100 pounds of force to move objects. Employees may use personal protective equipment, participate in an occupational health program, and must pass an eye exam during onboarding. The schedule is a 12-hour rotating day shift on a 2/2/3 pattern; the company may modify schedules and request overtime based on business needs.

Requirements

Prior experience in a regulated manufacturing environment.
Working knowledge of product security controls and material handling equipment.
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 read, write, speak, and understand English to interpret SOPs, batch records, and work instructions.
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 perform the physical demands of the role, including climbing, kneeling, repetitive motion, temperature changes, and exerting up to 100 pounds of force to move objects.
Ability to pass an eye exam during onboarding.
Ability to participate in an occupational health program, which may include medical assessment, surveillance, vaccination, and testing.
Ability to use required personal protective equipment, which may include respirators, PAPR, gowns, gloves, face protection, and other barrier equipment.

Nice To Haves

High school graduate, vocational school graduate, or equivalent.
At least 1 year of experience in pharmaceutical, biotechnology, or cGMP-regulated manufacturing.
Experience working in a lean manufacturing environment.
Working knowledge of cGMP principles, including documentation practices, safety procedures, and compliance expectations.
Working knowledge of Microsoft applications, SAP, and/or Veeva Vault.

Responsibilities

Operate assigned machinery, supply it with materials, monitor equipment status, reintroduce materials, manually palletize finished materials, and maintain product flow.
Start up machinery, including equipment setup, recipe selection, SCADA and HMI data entry, minor adjustments, and critical sensor challenges.
Perform manual packaging and rework of in-process and finished materials as required.
Use motorized and manual pallet jacks and non-motorized lifts to move, store, or deliver materials safely.
Perform visual quality inspections and sampling of in-process materials, escalating concerns to the Lead and Management.
Troubleshoot minor issues, including clearing minor jams and identifying equipment defects, and escalate as needed.
Perform inventory control and reconciliation using SAP and WES.
Clean and maintain assigned areas and perform line clearances to support a cGMP environment.
Complete batch record and GMP documentation entries and perform required mathematical computations.
Follow safety procedures, including requirements for PPE, LOTO, ergonomics, material and chemical handling, waste handling, spill controls, and human safety.
Support lean activities and process improvement, including 5S, problem-solving, and manual data collection.
Execute protocols for equipment qualification and process validation as required.
Provide flexible support to other Manufacturing Team areas as needed.
Acquire and maintain required certifications and qualifications for the assigned work area.
Attend and actively participate in daily Tier 0 meetings.
Adhere to the Quality Management System, including the Quality Manual, Quality Policy, SOPs, cGMPs, and applicable regulations and standards.