Senior Process Engineer | The Photonics Group

Date Posted: 
Thursday, September 11, 2014
Position Location: 
West Virginia
Job Description: 

Reference Number: 9514KL3
Location: WV
Direct scientific support of process team, oversee process performance based on parameter monitoring in production, continuously improving quality and efficiency. All work performed in compliance to cGMPs, SOPs and applicable guidelines and policies.

Ensure yield efforts are adequately resourced and provide leadership to yield group ensuring investigations are conducted using recognized methods. Utilize LEAN tools and techniques to identify root causes of problems. Optimize manufacturing processes.

Ensure compliance with regulatory/corporate requirements. Continuously improve metrics in this regard for staff and areas of responsibility. Provide subject matter expertise to support inspections and audits. Create process/cGMP risk analysis. Responsible for real time monitoring of CPPs and CQAs. Provide quarterly summary updates to management of CPP/CQA trending.

Identification of future budgetary requirements, preparation of department annual budget and ensuring the department operates within budge. Manage department within targeted budget, projections, attendance, turnover and other goals as established. Identify productivity and efficiency targets and deliver cost savings annually.

Support and execute continuous improvement actions and projects, e.g. to improve process capability, Throughput time (TPT), minimize wastes of materials and reworks. Champion operational excellence initiatives in the plant.

Lead the process expert team to support immediate issues that occur on the shop floor during manufacturing. Provide subject matter expertise and fundamental knowledge for the manufacturing process.

Minimum requirements
Bachelors degree in Engineering/ Science/Technology or related discipline. Masters degree in Engineering/ Science/Technology or related discipline, preferred.
Minimum: 5 years industrial experience in a regulated Medical Device/Pharmaceutical environment, including 5 years in a Supervisory/Management role. Would prefer 10 years industrial experience and 5 years middle/senior management experience. Lean Qualification.