Manufacturing Technician II - DAP

Resilience•West Chester, OH

13d

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 includes operating packaging equipment, in-process monitoring, line clearances, cosmetic inspection, cleaning, and completing batch record entries. The position also supports safety, compliance, process improvement, equipment qualification, validation, and other areas of the Manufacturing Team as needed. This is a primarily non-sedentary role involving physical activity and use of personal protective equipment. Employees must adhere to the applicable Quality Management System, quality policies, SOPs, cGMPs, and regulations. The stated schedule is 12-hour shifts on a 2/2/3 rotation; schedules may be modified based on business needs. Work authorization sponsorship, including visas, is not available.

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 effectively 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 pass an eye exam during onboarding.
Ability to meet the physical demands of the role, including climbing, kneeling, repetitive motion, adapting to temperature changes, and exerting up to 100 pounds of force to move objects.

Nice To Haves

High school graduate, vocational school graduate, or equivalent.
1+ years 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, including servicing machines with materials, monitoring equipment status, reintroducing materials, manually palletizing finished materials, and maintaining product flow.
Start up machinery by setting up equipment, selecting recipes, entering data on SCADA and HMI, making minor adjustments, and performing critical sensor challenges.
Perform manual packaging and rework of in-process and finished material as required.
Operate 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.
Perform minor troubleshooting, including clearing minor jams and identifying equipment defects, and escalate issues as needed.
Perform inventory control and reconciliation using SAP and WES.
Clean and maintain housekeeping and line clearance in assigned areas to support a cGMP environment.
Complete batch record and GMP documentation entries and perform required mathematical computations.
Follow safety procedures covering PPE, LOTO, ergonomics, materials, chemicals, waste handling, spill controls, and human safety.
Support lean activities and process improvement, including 5S, problem-solving, and manual data collection.
Execute protocols as required for equipment qualification and process validation.
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.