Production Operator

i-Pharm Consulting; Wilmington (DE); On-site; USD 83,000 - 95,000; Full time

Job summary

i-Pharm Consulting in Wilmington, Delaware seeks a skilled pharmaceutical manufacturing operator to join a full-time team on 1st shift. You will operate tablet presses, encapsulators, and related equipment, perform in-process quality checks, and ensure batch documentation accuracy in a GMP environment.

Applicants should have at least 3 years of GMP manufacturing experience, familiarity with MES/ERP/LIMS systems, and a strong focus on data integrity and compliance.

Qualifications

• Experience in GMP-regulated manufacturing environments is required.
• Ability to read SOPs and batch records to perform manufacturing activities safely.
• Familiarity with data integrity principles and regulated documentation.

Responsibilities

• Operate and monitor pharmaceutical manufacturing equipment (tablet presses, encapsulators, roller compactors, fluid bed dryers, blenders, coaters).
• Execute batch production activities and maintain accurate batch documentation.
• Perform in-process quality checks and make routine adjustments within approved limits.
• Complete equipment setup, line clearances, and changeovers to support operations.
• Perform cleaning activities and CIP/SIP processes while ensuring cleanliness and line-release compliance.
• Support deviation investigations, troubleshooting, and CAPAs with Quality, Engineering, and Maintenance.
• Maintain compliance with cleanroom, gowning, safety, and data integrity in regulated environments.

Skills

GMP compliance

SOP interpretation

Batch documentation

Data integrity

Tools

Tablet presses

Encapsulators

Roller compactors

Fluid bed dryers

Blenders

Coaters

MES

ERP

LIMS

Electronic batch records

Job description

LOCATION: Wilmington, Delaware (M/F 1st Shift)

SALARY: $83,0000 - $95,000 (Full-time opportunity)

Responsibilities:

• Operate and monitor solid dose manufacturing equipment, including tablet presses, encapsulators, roller compactors, fluid bed dryers, blenders, and coating systems, in accordance with GMP and validated process parameters.
• Execute production activities such as material dispensing, blending, granulation, compression, encapsulation, coating, filling, and packaging while maintaining accurate batch documentation.
• Perform in-process quality checks including weight variation, hardness, thickness, moisture, pH, and visual inspections, making routine process adjustments within approved limits.
• Complete equipment setup, line clearances, product changeovers, and assembly/disassembly activities to support efficient manufacturing operations.
• Perform equipment and area cleaning activities, including manual cleaning and CIP/SIP processes, ensuring compliance with cleanliness and line-release requirements.
• Support deviation investigations, troubleshooting, and continuous improvement initiatives in collaboration with Quality, Engineering, and Maintenance teams.
• Maintain compliance with cleanroom, gowning, safety, and data integrity requirements while working in regulated manufacturing environments.

Requirements:

• Experience operating pharmaceutical manufacturing equipment such as tablet presses, encapsulators, roller compactors, fluid bed dryers, blenders, and coaters is essential.
• Minimum 3 years' experience in pharmaceutical, biotechnology, medical device, food, beverage, or other GMP-regulated manufacturing environments.
• Working knowledge of cGMP regulations, batch documentation practices, cleanroom operations, and data integrity principles.
• Ability to interpret SOPs, batch records, process instructions, and technical drawings to perform manufacturing activities safely and accurately.
• Familiarity with production systems such as MES, ERP, LIMS, or electronic batch record platforms is advantageous.
• Experience supporting audits, inspections, investigations, CAPAs, and other quality-compliance activities.
• Strong attention to detail, problem-solving skills, and the ability to work effectively in a fast-paced manufacturing environment.
• Able to work extended shifts in controlled environments while wearing appropriate PPE and handling routine material movement requirements.