Production Engineer

Job Description

General Responsibilities:

Monitoring: Closely monitor day-to-day plant operations. Monitor yield, costs, downtime, productivity, WIP and quality for the assigned production process. Monitor whatever is necessary to effectively manage and optimize the production process.

• Develop and track daily, weekly and monthly yields and production for each step versus standards.
• Develop a nearly real-time database of key operating data for each step for use in process optimization.
• Report daily production, yield, and downtime for each step in the assigned production process in order to better optimize production, costs and quality.
• Regularly attend pre-shift brief
• Monitor quality of all raw materials, WIP and production

Scheduling: Assure the production schedule is met through the scheduling of raw materials, trouble shooting production and process issues, timely maintenance of the production equipment and proper direction.

• Ensure the operators are given timely and clear instructions as to operating schedules, WIP blends, etc.
• Manage downtime, shutdowns and maintenance to maximize productivity.
• Integrate product forecast with equipment utilization.
• Ensure all necessary supplies are on-hand to achieve our production and cost goals
• Provide timely disposition and movements of raw materials, in process and finished product.
• Perform level-loading on unit operations to avoid swings in WIP build and ensure smooth operation between Manufacturing, Packaging, and sales demand

Cost Reduction: Aggressively work to reduce operating costs by reducing downtime, increasing productivity, increasing yields and reducing raw material costs in the assigned production process.

• Identify and support the implementation of process improvements.
• Optimization of batch reaction and distillation unit operations.
• Assess and optimize workflows and utilization (both personnel and equipment)

Process & Production Supervision: Plans, directs and coordinates to ensure that production meets output and quality goals while remaining in budget

• Trouble-shoot production and process issues
• Works with supervisors, operators and maintenance personnel to solve process problems and advise corrective actions as needed;
• Resolves operational, manufacturing, and maintenance problems to ensure minimum costs and prevent operational delays
• Provide direction and training as required.
• Issue daily notes as necessary to communicate in a clear and timely fashion, current operating conditions and materials usage instructions to the floor operating personnel.
• Work on increasing capacity of the assigned unit
• Maintain up-to-date process related documentation (development of standard work instructions; SOPs, validation protocols, technical instructions, etc.).
• Participating in the development of standard work instructions;

Safety: Ensure the process is operated in a safe fashion. Our goal is zero safety incidents or accidents.

• Implement, adhere to and insure proper change management procedures are followed.
• Evaluate, understand and communicate all pertinent safety issues and hazards associated with each assigned process step.
• Ensure all operating and maintenance personnel are following all safety guidelines and procedures.
• Initiate and implement safety related projects.
• Participate in PHA in assigned production process.
• Insure a safety review is completed for new project (minor or major) or process change in assigned production process.
• Initiate and complete projects to ensure redundant safety interlocks exist for all potential hazards
• Continuously improve current state by assessing need for interlocks, bypasses, etc., and resolve with automation and operations personnel

Health: Ensure company standards & regulatory requirements are met with respect to chemical exposures in your assigned production process

• Insure all personnel use PPE appropriate for task they are performing
• Working with EH&S, insure PEL compliance for all personnel and areas
• Initiate and complete projects to reduce operator contact with chemicals

Environment: Ensure company standards & regulatory requirements are met with respect to air, waste and water compliance in your assigned production process

• Working with EH&S, insure RCRA, waste water and air compliance
• Initiate and complete projects to reduce waste disposal costs
• Achieve a goal of zero environmental emissions or incidents in their assigned area

Quality: Monitor quality of all raw materials, WIP and production to insure

• Participate in quality investigations, including process deviations and customer complaints.
• Manage CAPAs related to quality investigations, especially long-term preventative actions
• Perform process-related discrepancy investigations as required.
• Work with the Quality Manager to insure proper scheduling of samples to meet production goals.
• Develop and execute validation protocols for changes that impact the filed manufacturing process

Projects: Initiates, manages and completes projects in their assigned areas as well as other assigned projects to support production and process improvements.

• Conceive, conceptualize, design, develop, manage and implement capital and other projects in their assigned areas to increase capacity, reduce costs and achieve other production, cost, yield, safety, quality, and environmental goals.
• Manage a variety of replacement-in-kind and other maintenance projects
• Manage a team of personnel for each project, ensuring timelines and budget are met

Other Duties

• Assist in annual budget preparation, the development of cost standards and other capital forecasts
• Support requests from Regulatory Affairs related to the operations
• Assist in the validation of equipment and process changes
• Help lead new process roll-outs in the department, such as tools, methodologies, corporate initiatives, etc.
• Support cultural initiatives for the site
• Conduct other tasks as required

Qualifications

Requirements:

• Minimum BS in Chemical Engineering.
• 3+ years experience working in a chemical or organic synthesis pharmaceutical manufacturing facility.
• Strong Process Engineering background.
• Practical experience with batch and continuous distillation desirable.
• Experience with HHCs such as chlorine and HF essential.
• Strong experience with organic chemical reactions desirable.
• Experience with PLCs and automation is highly preferred
• Experience with validation and batch records in an FDA-regulated environment desirable
• Ability to relate well with people
• Experience with training personnel is desirable
• Proficient with MS Word and Excel.
• Experience with Lean and Six Sigma, as well as analytical tools such as Minitab or Aspen, is desirable
• Able to work independently with little supervision.
• Broad and deep knowledge of many chemical engineering unit operations
• Thorough understanding of principles and practices of chemical & pharmaceutical manufacturing, cGMPs, utility systems
• Excellent written & verbal communication skills are needed.
• The ability to multi- task is essential