Process Engineer III

Job Description

Location: Greenville, NC

The Greenville, North Carolina, USA site is a large, multipurpose pharmaceutical development, manufacturing, and packaging campus. The operation provides both development and commercial services for sterile injectable forms.

Position Summary

Provides technician support and expertise to sterile pharmaceutical production and customer technical transfers, modifications to existing processes, and auxiliary support systems. Leads process improvements to increase safety, reduce costs, improve quality, and improve Overall Equipment Effectiveness (OEE). Emphasizes minimizing production equipment downtime to increase equipment availability and efficiency along with regulatory compliance for process and support systems. Works closely with Production, Maintenance, Validation, and Quality to maintain cGMP compliance, injury-free workplace, and on-time product delivery.

Key Responsibilities:

• Provide technical expertise and support in meeting business unit objectives and growing production's Overall Equipment Effectiveness (OEE). Maintains system design and associated documentation.
• Diagnoses and resolves difficult process and equipment interactions to maintain system readiness. Frequently, this effort requires collaboration with other teams. Communicates resolution summary to Area Leadership.
• Develop process flow diagrams, problem-solving guides, authors Standard Operations Procedures (SOP), and Job Aids to increase process efficiencies and repeatability.
• Creates and leads all aspects of alignment to User Requirement Specifications (URS), Functional Specifications, Design Specifications, and related user documentation to achieve and define process functionality and compliance.
• Establishes technical fit into existing facilities and equipment layouts, identifies process requirements, recognizes efficiency and safety gaps, and drives technical solutions.
• Provides supporting data on process systems and equipment to production and quality investigations along with proposing solutions and improvement opportunities.
• Collaborates with Validation, Engineering, and Customer teams to ensure process consistency during routine operations and modifications to processes to maintain GMP standards (FAT, SAT, IQ/OQ/PQ).
• Develops and Trains resources on technical processes using flow diagrams, job aids and work instructions.
• First Line of Defense for Process Troubleshooting and performs daily floor interactions with Operations, Maintenance, Quality and Safety.
• Owns results by taking actions to correct deficiencies and reports variances and exceptions in processes.
• Drives Continuous Improvements using metrics, TPM, 5S, and the PPI process.

Qualifications:

• BS Degree, preferably in Mechanical, Electrical or Industrial Engineering, with three (3) years of process experience.
• 3+ years of Process Improvement experience using Six Sigma, Lean, 5S, Trend Analysis methodologies preferred.
• Success in a regulated manufacturing environment in the Biotechnology, Pharmaceutical, and Medical Device industry preferred.
• Experience with Data Integrity principles for automation systems and audit trail data a plus.
• Outstanding attention to detail
• Strong verbal and written communication skills, and people skills to establish and maintain effective working relationships.

Incredible Benefits!

Medical, Dental, & Vision benefits - Effective Day 1

Paid Time Off & Holidays

401K Company Match up to 6%

Tuition Reimbursement

Employee Referral Bonus

Employee Discount Program

Employee Recognition Program

Charitable Gift Matching

Company Paid Parental Leave

Career Advancement Opportunities