Process EngineerGermer International - Pharmaceutical Recruiting • Lexington, KY, US
Process Engineer
Germer International - Pharmaceutical Recruiting • Lexington, KY, US
[job_card.variable_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]Interfaces with Engineering, Maintenance, R&T, and other clients; participates in routine communication between each of these groups and the business driving continuous improvement projects while providing clear technology direction and operational production support. Collaborates with Production Leadership, Procurement and external vendors to implement / lead business improvement plans. Accountable for product quality, safety, non-conforming product disposition, process throughput, waste minimization, training / skill usage of hourly employees, yield improvement, investigation and reduction of production variances for identified products / processes. Accountable for tracking process reliability, developing corrective action reports and complaint responses, implement process improvements and corrective actions. Works in conjunction with all plant engineering disciplines, R&T and customers to support new products and new manufacturing technology platforms in operations. Directs contractors and hourly employees to monitor processes, collect data, install equipment and make process modifications. Develops and implements metrics to monitor and improve process safety, performance of equipment, processes, and / or overall product quality trends to reduce process variability. May develop, design and implement capital projects to support plant initiatives. Provides timely and effective data analysis, root cause analysis, corrective and preventative action execution in response to process trends or out of control data points, or any other issues as they arise with platinum-level customer products. Leads multi-functional process capability improvement, MOC and validation efforts. Performs other duties as assigned.
The Process Engineer reports directly to the VP, North America Manufacturing. He / she interfaces with both management and union personnel from various levels. They also work closely with manufacturing, understanding the processes and the cause-and-effect relationship of the manufacturing cycle.
What we're looking for :
- Education : Bachelor's Degree in Chemical Engineering or a related field required.
- Experience :
- Minimum of five (5) years of related experience preferred.
- Minimum of two (2) years of experience working in a chemical manufacturing environment preferred.
- Knowledge of basic problem-solving tools (DMAIC) and lean manufacturing concepts (kanbans, kaizen, 5S) desired.
- General knowledge of chemistry and high purity chemical processing / engineering, and microelectronic applications required.
- Certification(s) : Six Sigma Black Belt certification preferred; Lean certification preferred.
- Additional Qualifications :
- Knowledge of OSHA, NFPC, HazWoper, and other governmental regulatory requirements (e.g., 21 CFR Part 820, cGMP, ISO, FDA, etc.) desired.
- Strong competency in Microsoft Office, specifically PowerPoint, Excel and Word.
- Demonstrated complex problem solving expertise and application of SPC tools and implementation.
- Working knowledge and experience in distillation and separation purification technologies, chemical synthesis unit operations, process control, environmental control systems, and clean manufacturing.
- Working knowledge of financial / cost systems and standard operating procedures process.
- Knowledge of FDA, cGMP, ISO 9000 and applicable state and federal environmental regulations.
- Demonstrated organizational, technical leadership, presentation and communication skills.
- Ability to understand analytical procedures, quantify analytical results, and make adjustments and corrections as needed.
- Ability to partner effectively with all functions and levels of the organization.
- Detail oriented; strong analytical, prioritization and problem solving skills.
How you will thrive and create an impact :
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Engineer • Lexington, KY, US
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