Pharmaceutical Production Operator

Linked Professional Services•Piscataway, NJ

About The Position

The Pharmaceutical Production Operator works in solid oral dosage manufacturing, with a focus on Granulation, Compression, and Coating processes. The role involves operating specialized pharmaceutical manufacturing equipment and ensuring production complies with FDA regulations, current Good Manufacturing Practices (cGMP), established procedures, and quality standards. The position is contract-to-hire and calls for direct pharmaceutical production experience in a fast-paced, highly regulated manufacturing environment. The schedule is first shift, 7:00 AM to 3:00 PM, Monday through Friday, with potential overtime and Saturdays. Previous hands-on experience as a pharmaceutical production operator in regulated pharmaceutical manufacturing is mandatory; general manufacturing experience alone does not meet the requirements.

Requirements

Minimum 3–5 years of hands-on pharmaceutical manufacturing experience.
Direct experience in solid oral dosage manufacturing.
Experience operating pharmaceutical Granulation, Compression, and/or Coating equipment.
Strong understanding of cGMP regulations and pharmaceutical manufacturing procedures.
Experience following SOPs and completing Batch Manufacturing Records (BMRs).
Ability to operate, monitor, and clean pharmaceutical production equipment.
Ability to identify manufacturing deviations and maintain strict quality standards.
Strong attention to detail, documentation accuracy, and workplace safety.
Ability to work independently and collaboratively in a team-oriented manufacturing environment.
Flexibility to work overtime and Saturdays as needed.
Previous hands-on pharmaceutical production operator experience in regulated pharmaceutical manufacturing is mandatory; general manufacturing experience alone does not meet the requirements.

Responsibilities

Operate, monitor, set up, and clean equipment used in Granulation, Compression, and Coating processes.
Perform manufacturing operations according to cGMP guidelines and established Standard Operating Procedures (SOPs).
Follow Batch Manufacturing Records (BMRs) to ensure accurate and consistent production.
Monitor equipment performance and manufacturing processes to maintain product quality and efficiency.
Identify, document, and report process deviations, equipment malfunctions, and quality concerns.
Perform equipment cleaning, line clearance, and changeover activities between production batches.
Maintain accurate production documentation and manufacturing records.
Follow FDA regulations, safety procedures, and pharmaceutical quality standards.
Collaborate with production, quality assurance, and maintenance teams to resolve manufacturing issues.
Maintain a clean, organized, and compliant production environment.