Business: Critical CareDepartment: ManufacturingLocation: Bethlehem
Job Overview
- Provides technical leadership, management and oversight to the assigned production process and product.
- Responsible to see that production, cost, yield, safety, quality, environmental goals are achieved on the assigned production process and product.
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.
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 Bethlehem operationsParticipate in the development of validation protocols.
- 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.
Job Info
- Job Identification 9154
- Job Category Manufacturing
- Posting Date 08/06/2025, 06:29 AM
- Job Schedule Full time
- Locations 3950 Schelden Circle, Bethlehem, PA, 18017, US
