Sr. Process Engineer
1851- Senior Process Engineer
This position within the Manufacturing Technology Team has the responsibility to design, install, and implement processes and equipment supporting GMP production of small molecule active pharmaceutical ingredients (APIs) in a safe, compliant, and efficient manner.
What The Job Entails
The Process Engineer must apply a broad range of safety, environmental, GMP, engineering, leadership and technical skills across a broad range of issues. Critical to the success of this position is adherence to cGMP and OSHA Process Safety Management regulations, development of robust, reliable production processes, and cost-effective installation of durable, multi-purpose (flexible) chemical and solids processing equipment.
The responsibilities of the Process Engineer include:
- Support technical transfer of new processes from concept through product delivery, including
- Define scale and equipment fit of new processes within existing facility
- Design and install new equipment and/or existing equipment modifications to support new process requirements
- Manage process safety concerns with accountability for PSM implementation using existing procedures (thermal hazards, relief design, PHA, etc.)
- Perform qualification and validation activities according to site master plan
- Generate project documentation and provide training to affected personnel
- Assist with project management activities, as required
- Use engineering expertise to assist in the execution of capital and expense projects for at the site.
- Provide technical support for other functional groups, including;
- Support during production activities to solve issues and help ensure safe and compliant execution of process procedures. On-call support will be required during new process start-ups.
- Generate and own change controls, quality events, CAPA, etc. within the quality system to support on-going production.
- Participate in team safety meetings and complete engineering related action items.
- Support administration of engineering document repository (AutoCAD Vault).
Our ideal candidate
Process Engineer requires Bachelor of Science Degree in Chemical Engineering or closely related field with 2+ years of experience. Sr. Process Engineer requires BS in Chemical Engineering with 7+ year of experience.
- Experience in manufacturing, engineering or project management work associated with pharmaceutical ingredients, specialty or fine chemicals.
- Batch manufacturing experience with a wide variety of unit operations and related equipment.
- cGMP manufacturing experience.
- Experience in both the project engineering and process engineering.
- Familiarity with cGMP's and FDA regulations.
- Familiarity with OSHA Process Safety Management Standard and other relevant codes and regulations