Project Engineer II
Job Summary:
The Project Engineer provides daily engineering support for the efficient and effective use of the Company’s manufacturing and facilities equipment. The Project Engineer will also be directly responsible for management of capital projects and all associated activity relating to the site engineering effort for new construction and manufacturing/facilities equipment installation and to support the manufacturing of quality pharmaceuticals in a timely, compliant, safe and cost effective manner.
Responsibilities:
- Support plans and programs for the department that will achieve the company’s yearly and long-term objectives
- Participate in site Master Planning efforts.
- Assist in financial planning relating to capital budgets
- Execute capital project work as prescribed by the capital budget
- Generate ROI and cost justifications for systems upgrades and replacements
- Support the department’s expense budget
- Maintain budgets for assigned capital project work up to $1MM
- Supervise outside contractors and vendor OEMs for equipment installation, start-up, repair, troubleshooting and routine preventative maintenance
- Assist with implementation and management of engineering, safety, and compliance systems; creation and execution of design and validation plans
- Understanding and interpretation of PLC, automation and instrumentation issues
- Function as SME in one or more functional areas and proactively address equipment issues with emphasis on minimizing downtime and maximizing operational efficiency
- Update and maintain site equipment and facility drawings; read and understand PID, architectural and MEP drawings
- Development of equipment qualification protocols, SOP’s, and training modules; maintain and create detailed specifications (DDS, URS, SDS)
- Manage and document changes to equipment, project activities, and address CAPAs and Deviations within the site Quality Management System
Education/Qualifications:
- Bachelor's Degree Required
- 3-5 years of engineering experience in the pharmaceutical manufacturing arena with specific knowledge of pharmaceutical mfg. equipment and facility systems desirable.
- A solid understanding of cGMP’s and other regulatory requirements.
- Excellent technical (engineering) working knowledge, including working knowledge of PC- and PLC-based control systems, staying current with the latest pharmaceutical industry trends.
- A strong working knowledge in reference to validation practices and project management.
- The ability to handle multiple projects and assignments with varying priorities in a manner that meets the Company’s goals
- Capable of optimizing processes in respect to financial efficiency, system performance, or both
- Working knowledge and proficiency with AutoCAD or other drawing development software required
- Experience with reading PLC ladder logic, automation system platforms, and CMMS data entry & report generation preferred
- Traditional office environment with frequent walking to other areas of the facility and exposure to outside elements; able to stand for long periods of time occasionally based on job demands
- Occasional business travel up to 3 weeks per year
