Production Engineer
Do you have experience working in a chemical or organic synthesis pharmaceutical manufacturing facility? Our client, a global pharmaceutical client, is looking for a Production Engineer to grow their joining team.
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 goalsProvide 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 demandCost 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 issuesWorks 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 delaysProvide 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 unitMaintain 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 hazardsContinuously improve current state by assessing need for interlocks, bypasses, etc., and resolve with automation and operations personnelHealth : 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 performingWorking with EH&S, insure PEL compliance for all personnel and areasInitiate and complete projects to reduce operator contact with chemicalsEnvironment : 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 complianceInitiate and complete projects to reduce waste disposal costsAchieve a goal of zero environmental emissions or incidents in their assigned areaQuality : 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 actionsPerform 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 processProjects : 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 projectsManage a team of personnel for each project, ensuring timelines and budget are metOther Duties
Assist in annual budget preparation, the development of cost standards and other capital forecastsSupport requests from Regulatory Affairs related to the operationsAssist in the validation of equipment and process changesHelp lead new process roll-outs in the department, such as tools, methodologies, corporate initiatives, etc.Support cultural initiatives for the siteConduct other tasks as requiredQualifications
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 preferredExperience with validation and batch records in an FDA-regulated environment desirableAbility to relate well with peopleExperience with training personnel is desirableProficient with MS Word and Excel.Experience with Lean and Six Sigma, as well as analytical tools such as Minitab or Aspen, is desirableAble to work independently with little supervision.Broad and deep knowledge of many chemical engineering unit operationsThorough understanding of principles and practices of chemical & pharmaceutical manufacturing, cGMPs, utility systemsExcellent written & verbal communication skills are needed.The ability to multi- task is essential
