Manufacturing Technician II - DAP

Job Responsibilities

Operations

• Perform the duties of operating assigned machinery: service machines with materials, monitor equipment status, reintroduce materials, manually palletize finished materials, and ensure smooth product flow.
• Start-up machinery including equipment setup, recipe selection, data entry on SCADA and HMI; make minor adjustments and perform critical sensor challenges.
• Perform manual packaging tasks as required including hand packaging and rework of in-process and finished material.
• Operate light material handling equipment (motorized and manual pallet jacks, non-motorized lifts) to safely move, store, or deliver material.
• Perform visual quality inspection and sampling of in-process materials; promptly escalate concerns to Lead and Management as needed.
• Perform minor troubleshooting including clearing minor jams and identifying equipment defects; escalating to the Lead and Management as needed.
• Perform inventory control and reconciliation activities using SAP and WES.
• Perform cleaning, housekeeping, and line clearance activities for assigned areas to maintain a cGMP environment.

Documentation & Compliance

• Perform batch record and GMP documentation entries; perform mathematical computations as required.
• Follow job-related safety procedures including PPEs, LOTO, ergonomics, and material/chemical/waste handling, spill controls and human safety.
• Support lean activities and process improvement work including 5S, problem-solving, and manual data collection.
• Execute protocols as required as part of equipment qualification and process validation work.

Training & Development

• Provide flexible support to other areas of the Manufacturing Team as needed.
• Acquire and maintain all required certifications and qualifications for the assigned work area.
• Attend and actively participate in daily Tier 0 meetings.

Experience & Education

Minimum Qualifications

• 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 the ability to perform routine calculations (e.g., weights, measures, 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, escalating issues as needed.
• Basic problem-solving skills and the ability to identify deviations or inconsistencies in processes or documentation.
• Ability to work effectively as part of a team in a fast-paced production environment.

Preferred Qualifications

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

Physical & Work Environment

• This role is primarily a non-Sedentary role. This can include climbing, kneeling, repetitive motion, temperature changes, and exerting up to 100 pounds of force to move objects.
• Visual acuity such as working with data & figures, viewing computer terminal, extensive reading, operating machinery, operating motor vehicles, general observations of facilities, etc.
• Participation in an occupational health program, which can include medical assessment, surveillance, vaccination, and testing.
• Use of personal protective equipment, which can include respirators, Personal Air Purifying Respirators [PAPR], gowns, gloves, face protection, other barrier equipment, etc.
• All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role.
• Ability to pass eye exam during onboarding.

Work Schedule

[12 hour – 2/2/3] The work schedule listed reflects the employee’s expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, including a request to work overtime, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments.