Process Engineer II
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Job Location:
Greenville, NC - USA
Monthly Salary:
Not Disclosed
Posted on:
11 hours ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
12 hr shift/nightsEnvironmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards Cleanroom: no hair products jewelry makeup nail polish perfume exposed piercings facial hair etc... allowed Office Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)Job Description
Position Summary:
Join a team that is unwavering in its commitment to delivering outstanding technical support and expertise to sterile pharmaceutical production 24/7! As a Process Engineer II you will be pivotal in guaranteeing seamless operations by assisting with customer technical transfers modifying current processes and supporting auxiliary systems. Your efforts will be instrumental in driving process improvements to enhance safety reduce costs improve quality and increase Overall Equipment Efficiency (OEE). Work closely with Engineering Operations Maintenance Validation and Quality teams to ensure compliance with regulations and cultivate a workplace that is free from injuries. This is a 12-hour rotating shift position following a 2-2-3 schedule either straight days or nights.
Key Responsibilities:
Provide technical expertise and support to meet business unit objectives and improve OEE maintaining system construction and documentation.
Diagnose and resolve complex process and equipment interactions to ensure system readiness often collaborating with other teams and communicating resolutions to leadership.
Act as the Subject Matter Expert (SME) regarding equipment and process functionality for Production and Utilities.
Develop process flow diagrams problem-solving guides and advanced troubleshooting aids to increase efficiencies and repeatability and train internal resources.
Offer SME input during the development of CAPEX Equipment Upgrades for compliance and efficiency on Sterile Fill/Finish equipment.
Coordinate planned interruptions for processing areas/building during shutdowns as required.
Develop modify and approve process equipment recipes while adhering to SOPs.
Offer data assistance for production and quality inquiries suggesting resolutions and enhancement possibilities.
Collaborate with Engineering Operations Maintenance Quality and Safety teams on the production floor dedicating 70-90% of your time during shifts.
Collaborate with collaborators to prioritize activities and resolve conflicts.
Document conditions actions and results of work performed in logbooks and shift reports.
Drive Continuous Improvements using metrics TPM 5S and the PPI process.
Frequent Contacts:
Internal
Customer Facing Process Engineer Maintenance and Operations Colleagues.
External
Equipment and Supply Vendors
Minimum Requirements/Qualifications:
Associates degree in Mechanical Electrical or Industrial Engineering
Three years of experience in processes.
Ideally 1 years of Process Improvement experience applying Six Sigma Lean 5S and Trend Analysis approaches.
Experience in regulated manufacturing environments within Biotechnology Pharmaceutical or Medical Device industries is a plus.
Knowledge of Data Integrity principles for automation systems and audit trail data is advantageous.
Outstanding attention to detail and organizational skills to manage time and prioritize tasks.
Strong verbal and written communication skills along with the ability to establish and maintain effective working relationships.
Other Job Requirements:
Adhere to OHS policies and procedures to ensure a safe and healthy workplace environment.
Perform other duties as assigned.
Key Skills
- Lean Manufacturing
- Six Sigma
- Distributed Control Systems
- Continuous Improvement
- Process Improvement
- Minitab
- Root cause Analysis
- Process Engineering
- cGMP
- Kaizen
- Programmable Logic Controllers
- Manufacturing
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
