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Catalent · 1 day ago

Process Engineer I

Greenville, NC

Full-time

Onsite

New Grad, Entry Level

Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. The Process Engineer I supports day-to-day development and commercial manufacturing operations for oral solid dose products, focusing on equipment readiness, process execution support, data analysis, and documentation under cGMP.

BiotechnologyHealth CareManufacturingPharmaceutical

H1B Sponsor Likely

Responsibilities

Provide floor support for manufacturing/packaging activities; monitor processes, perform basic troubleshooting, and escalate issues appropriately

Assist with commissioning, qualification, and validation (FAT/SAT/IQ/OQ/PQ) of process equipment with guidance from senior engineers and Validation

Collect, trend, and analyze process data; summarize findings and recommend routine corrective actions

Participate in investigations (deviations, OOS/OOT, complaints) and execute corrective/preventive actions (CAPAs)

Draft and maintain cGMP documentation (SOPs, work instructions, batch records, standard test procedures) and support change controls

Support creation of User Requirements (URS) and equipment specifications as assigned; interface with vendors for routine technical information

Contribute to continuous improvement projects (5S, SMED, Lean, Six Sigma) to increase safety, quality, delivery, and cost performance

Adhere to EHS requirements; identify hazards and support implementation of countermeasures

Provide basic training to operators on procedures and equipment operation under supervision

Qualification

Oral Solid Dosage (OSD)CGMP DocumentationValidation ProtocolsContinuous ImprovementData AnalysisBasic TroubleshootingTeam CollaborationTechnical Communication

Required

Bachelor's in Engineering or related discipline

Ability to stand and walk in production areas; lift/push/pull up to 25 lbs. occasionally; work around moving/mechanical equipment

This position requires that a respirator be worn for your safety, and as such, employment is contingent upon being able to complete a medical evaluation with satisfactory results

Preferred

Experience with oral solid dosage (OSD) products in a pharmaceutical manufacturing environment

Familiarity with validation protocols and change control

Benefits

152 hours of PTO + 8 paid holidays

Company

Catalent

Catalent - Blow-Fill-Seal Sterile CDMO Business is focusing on complex clinical to commercial stage formulation and manufacturing. It is a sub-organization of Catalent Pharma Solutions.

Founded in 2007

Somerset, New Jersey, USA

10001+ employees

https://www.catalent.com

H1B Sponsorship

Catalent has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2022 (1)