Manufacturing Technician II, DAP (Nights)

Resilience•West Chester, OH

1d•$22 - $32

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, monitoring processes, conducting line clearances and cosmetic inspections, cleaning work areas, and completing batch record entries. The position follows a 2-2-3 schedule of 12-hour shifts, from 6:00 p.m. to 6:30 a.m. Employees are expected to follow the applicable Quality Management System, including the Quality Manual, Quality Policy, SOPs, cGMPs, and other relevant regulations and standards. The company may modify work schedules, including requesting 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 a primarily non-sedentary role that can involve climbing, kneeling, repetitive motion, temperature changes, and exerting up to 100 pounds of force to move objects.
Ability to meet visual acuity needs, including viewing data and figures, computer terminals, and machinery and performing extensive reading and general facility observations.
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, vocational school, or equivalent graduation.
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 materials, monitor equipment, reintroduce materials, manually palletize finished materials, and maintain product flow.
Set up and start machinery, select recipes, enter data on SCADA and HMI systems, make minor adjustments, and perform critical sensor challenges.
Perform manual packaging and rework of in-process and finished materials as needed.
Use light material handling equipment, including motorized and manual pallet jacks and non-motorized lifts, to move, store, or deliver materials safely.
Conduct 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, escalating issues 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 calculations.
Follow job-related safety procedures, including PPE, LOTO, ergonomics, material, chemical and waste handling, spill controls, and human safety practices.
Support lean activities and process improvements, 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.
Obtain 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, applicable procedures, cGMPs, regulations, and standards.
Participate in an occupational health program, which may include medical assessment, surveillance, vaccination, and testing.
Pass an eye exam during onboarding.