Provide on-site process engineering support to a pharmaceutical plant’s Project Engineering group.
PHARMACEUTICAL MANUFACTURER ON-SITE PROCESS ENGINEERING ASSISTANCE
The client owns and operates a facility that manufactures Active Pharmaceutical Ingredients. The facility adheres to FDA cGMP regulations and OSHA Process Safety Management (PSM) requirements. Process Engineering Associates, LLC (PROCESS) was contracted to provide on-site technical support to assist Project Engineering with the execution of capital projects.
Specific project descriptions for which assistance was provided include the following:
- Installation of nitrogen feed system(s) for inerting several production scale reactors.
- Design and installation of small feed tank for a Pilot Plant spray dryer.
- Installation of a used jacketed reactor for production.
- Retrofit of critical chemical storage tanks with level sensors and safety interlocks (via Delta V DCS) to automated inlet valves to prevent tank overfilling.
Specific project tasks included:
- Worked with Facility Production Management to define the scope of work for capital projects.
- Generate Bid Specifications for mechanical/electrical contractors to solicit for project estimates.
- Generate specifications for project-related equipment including:
- Materials of construction for process piping for various corrosive chemicals
- Automated valves
- Level transmitters
- Pressure transmitters
- Generate cost estimates and schedules for capital projects.
- Work with facility Safety, Health and Environmental (SHE) department to adhere to all applicable SHE and cGMP regulations during the completion of projects.
- Generate Work Instructions for new processes.
- Review and revise Functional Requirement Specifications (FRS) for programmable logic controllers (PLC) upgrades associated with new instrumentation installations.
- Perform Pre-Startup Reviews (PSSRs) with production personnel including training on new equipment before the turnover of new systems.
- Generate recommended spare part lists and recommended preventive maintenance frequency to facility Maintenance Department after installation of new system/equipment.
- Pharmaceutical Manufacturing
- On-site project engineering support