Process Engineer I

Catalent

1d • Onsite

About The Position

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. Catalent’s Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. Catalent’s Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development. The Process Engineer l supports day-to-day development and commercial manufacturing operations for oral solid dose (OSD) products. This role focuses on equipment readiness, process execution support, data analysis, and documentation under cGMP as well as works cross-functionally with Operations, Validation, Facilities/Engineering, Quality, and Product Development to improve reliability, yield, and compliance.

Requirements

• 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. The medical evaluation is conducted via an external vendor assigned by Catalent.

Nice To Haves

• Experience with oral solid dosage (OSD) products in a pharmaceutical manufacturing environment preferred
• Familiarity with validation protocols and change control preferred
• Work in a fast-paced, performance-driven, customer-focused environment

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

Benefits

• 152 hours of PTO + 8 paid holidays
• Catalent offers rewarding opportunities to further your career!
• Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world.
• Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.
• Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us.
• Join us in making a difference.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees