Process Engineer III, Manufacturing Engineering

Work Schedule
Standard Office Hours (40/wk)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Location: Greenville, NC

Join Thermo Fisher Scientific to contribute globally, making a positive impact daily.

Business Information

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 injectables forms.

Position Summary

Provide technician support and expertise to sterile pharmaceutical production and customer technical transfers, modifications to existing processes and auxiliary support systems. Lead process improvements to increase safety, reduce costs, improve quality, and improve Overall Equipment Efficiency (OEE). Emphasize minimizing production equipment downtime to increase equipment availability and timeliness along with regulatory compliance for process and support systems. Work closely with Production, Maintenance, Validation and Quality to maintain cGMP compliance, an injury-free workplace, and timely product delivery. Typical hours are 7a - 4p, Monday through Friday.

Key Responsibilities:

• Provide technical expertise and support with meeting business unit objectives and growing production's OEE. Maintain system design and associated documentation.
• Diagnose and resolve difficult process and equipment interactions to maintain system readiness. Frequently, this effort requires collaboration with other teams. Communicate resolution summary to Area Leadership.
• Develop process flow diagrams, problem solving guides, author Standard Operations Procedures (SOPs) and Job Aids to increase process efficiencies and repeatability.
• Direct alignment with User Requirement Specifications, Functional Specifications, Design Specifications, and user documentation.
• Establish technical fit into existing facilities and equipment layouts, identify process requirements, recognize efficiency and safety gaps and drive technical solutions.
• Provide supporting data on process systems and equipment to production and quality investigations along with proposing solutions and improvement opportunities.
• Collaborate with Validation, Engineering and Customer teams to ensure process consistency during routine operations and modifications to processes maintain GMP standards (FAT, SAT, IQ/OQ/PQ).
• Develop and train resources on technical processes using flow diagrams, job aids and work instructions.
• First Line of Defense for Process Troubleshooting and perform daily floor interactions with Operations, Maintenance, Quality and Safety.
• Own results by taking actions to ensure accuracy and report variances and exceptions in processes.
• Drive Continuous Improvements using metrics, TPM, 5S, and the PPI process.

Qualifications:

• Bachelor's degree required, preferably in Mechanical, Electrical or Industrial Engineering
• Three (3) years of Process experience, preferably a manufacturing process in Pharmaceuticals.
• 3+ years of Process Improvement experience using Six Sigma, Lean, 5S, Trend Analysis methodologies preferred.
• Successful history in a regulated manufacturing environment in the Biotechnology, Pharmaceutical, and Medical Device industry is a plus.
• Experience with Data Integrity principles for automation systems and audit trail data a plus.
• Outstanding attention to detail and organizational skills to manage time and prioritize tasks.
• Strong verbal and written communication skills, and people skills to establish and maintain effective working relationships.

We offer a competitive salary, an annual incentive bonus plan, 401K with company match up to 6%, tuition reimbursement and a range of other employee benefits! We foster an exciting company culture that encourages innovation, forward-thinking, and an outstanding career and development prospects. Come be a part of the team!