OSD Manufacturing Operator II – Onsite, Day Shift, New Site

U473 (FCRS = US473) Novartis Innovative Technologies Inc; Morrisville (NC); In loco; USD 38.000 - 71.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health benefits

401(k) with company match

Paid time off

Descrizione del lavoro

Novartis is seeking a Manufacturing Operator II, Oral Solid Dosage (OSD) for our Morrisville, NC site. You will execute tablet and capsule production, operate and troubleshoot GMP-compliant equipment, and complete batch records in a cleanroom environment.

This onsite role supports granulation, compression, coating, and encapsulation processes, with a day shift pattern as schedules are finalized. You will collaborate with Operations, QA, and cross-functional teams to ensure strict GMP adherence,

Competenze

• Bachelor's degree in Biology, Chemistry, Biotechnology, or related field with 2+ years cGMP manufacturing experience.
• Hands-on experience in Oral Solid Dosage (OSD) manufacturing, including tablet and capsule production.
• Experience operating, monitoring, and troubleshooting manufacturing equipment in an FDA-regulated environment.
• Strong understanding of GMP requirements, batch documentation, and manufacturing procedures.
• Ability to investigate, document, and elevate equipment, process, or quality issues.
• Effective communication and collaboration skills with the ability to work across Operations, QA, and cross-functional teams.

Mansioni

• Execute OSD manufacturing activities according to production schedules in GMP and safety requirements.
• Operate, monitor, and troubleshoot equipment used in tablet and capsule manufacturing processes.
• Perform manufacturing activities across granulation, compression, coating, and encapsulation operations.
• Complete batch records accurately, thoroughly, and on time in accordance with GMP expectations.
• Conduct equipment setup, cleaning, line clearance, and room preparation activities.
• Perform in-process checks, sampling activities, and routine production monitoring.
• Identify equipment or process issues and elevate deviations to Operations and QA.
• Support FDA inspection readiness through strict adherence to procedures and documentation standards.
• Contribute to continuous improvement initiatives that enhance safety, quality, and manufacturing efficiency.
• Maintain a safe, compliant, and organized manufacturing environment through strong HSE and 5S practices.

Conoscenze

Good Documentation Practices

Health, Safety, and Environment (HSE)

Manufacturing Processes

Manufacturing Production

Operational Excellence

Quality Control (QC)

Regulatory Compliance

Formazione

Bachelor's degree in Biology, Chemistry, Biotechnology, or related field

Descrizione del lavoro

Novartis is seeking a Manufacturing Operator II, Oral Solid Dosage (OSD) for our Morrisville, NC site. You will execute tablet and capsule production, operate and troubleshoot GMP-compliant equipment, and complete batch records in a cleanroom environment.

This onsite role supports granulation, compression, coating, and encapsulation processes, with a day shift pattern as schedules are finalized. You will collaborate with Operations, QA, and cross-functional teams to ensure strict GMP adherence,