Join growing pharmaceutical company and enjoy growth and top benefits. Company is offering relocation!
Be responsible for supporting coating/extrusion/packaging processes and equipment including planning, designing, and managing projects relating to the development, maintenance and improvement of manufacturing/process operations. Perform job functions in accordance with the Occupational Safety and Health Administration (OSHA) guidelines. Ensure compliance with the Standard Operating Procedures (SOP), the Food and Drug Administration (FDA) Regulations, Standard Test Methods (STM) and Current Good Manufacturing Practices (cGMP).
Report to the Sr. Director, Engineering and Maintenance
1. Responsible for engineering projects from conception to completion. Track costs and schedule.
2. Prepare or assist in the preparation of project validations including specifications, drawings, schedules, budgets, and Standard Operating Procedures.
3. Ensure that projects are designed and executed in accordance with Federal, State, and Local regulations and Good Manufacturing Practices.
4. Obtain competitive bids on projects, analyzes them, and develops recommendations.
5. Direct Maintenance personnel, contractors, and consultants as required to complete work.
6. Inspect work for conformance to specifications, drawings, and standards.
7. Ensure that projects are properly documented and information including as-builts are recorded and filed.
8. Identify and implement changes and improvements to coating/extrusion/packaging equipment and processes to improve safety and efficiency.
9. Tracks manufacturing/packaging process equipment uptime, yields and cost drivers including organizing and analyzing the information to identify and implement improvement opportunities.
10. Act as a resource to assist and/or mentor engineers and operations personnel.
The qualified candidate must have a minimum of 5 years of experience with BS (preferably in Engineering) or a minimum of 2-5 years of experience with MS (preferably in Engineering) some of which has been gained in the pharmaceutical or medical devices industry. The ideal candidate will have experience in pharmaceutical, coating manufacturing/packaging equipment and processes as well as exposure to statistical process control, Six Sigma, TPM, Lean and OEE programs. In addition to possessing solid knowledge of Engineering theory and the ability to apply it in a practical manner, the candidate must also have demonstrated the ability to solve technical problems involving many variables, meeting challenging deadlines and communicate effectively with contractors and fellow employees.
Must possess knowledge of computers, printers, plotters and various test equipment as well as word processing software, and project tracking software. Must possess solid knowledge of Engineering theory and the ability to apply it in a practical manner. Ability to solve multiple problems and deal with many variables and deadlines. Ability to deal effectively with contractors and fellow employees.
Must possess the ability to write concise reports. Ability to supervise and work well with other people.
Minimum of a Bachelor's degree (or equivalent) and 2-5 years of experience. However, a combination of experience and/or education will be taken into consideration.
Salary is between $60-90K + DOE