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This position is responsible for leading the activities and responsibilities associated with the day to day production of APIs, including production tracking and scheduling; shift instructions; troubleshooting; lock out tag out (LOTO) and safety oversight; and on call activities for manufacturing support. Incumbent will be the subject matter expert and provide leadership to the operators in the assigned area. This role will also include planning, developing, and recommending approaches to implement projects for optimizing production capacity, capability, and quality, while also ensuring optimal levels of energy conservation and environmental improvements.
- Plan, monitor, improve, and control Production output for each line to ensure that plant goals are achieved.
- Update all paperwork for the Production area, including daily output to lot specific batch sheets (when needed) and all Quality related items (e.g. SOP, ETS, QAR’s, etc.).
- Monitor production trends through statistical analysis; promptly address problems, trends and opportunities within the production process.
- Assist in troubleshooting of new equipment and process to eliminate problem area and decrease batch time/cycles.
- Work on start-up of new processes and equipment to de-bug and eliminate loss time.
- Oversee start-up validation and testing of units to comply with regulatory requirements
- Work with Regulatory Compliance group to create an effective Validation Plan
- Provide troubleshooting and production expertise for instrumentation, control technology, and/or production equipment.
- Document Maintenance procedures for plant equipment.
- Interface with Engineers, Production, Maintenance and Quality to coordinate capital project work.
- Write operating instructions for changes within the production process.
- Write standard work procedures for critical job tasks.
- Verify control schemes, interlocks, and safety devices designed by contractors.
- Select appropriate controlling and monitoring instrumentation when new equipment is installed.
- Train Production Operators in the proper operation of new equipment.
- Communicate with individuals within the Zoetis network to facilitate process developments.
- Provide technical assistance and piloting for process startups, process modifications, and process trouble shooting.
- Identify necessary training for maintenance for electrical and control equipment.
- Oversee LOTO and be act as the subject matter expert in the assigned area.
- Prepares engineering estimates for new or modified equipment processes.
- Drafts capital requests to obtain financial approval for equipment.
- Responsible for preliminary engineering and feasibility studies to ensure equipment is safe, reliable and accomplishes the needed tasks.
- Responsible for the engineering required to compare the installation and fabrication of structures, equipment, and determine what equipment is best suited for the operation.
- Prepares purchase requisitions to purchase equipment or needed supplies to support the project for the new or modified equipment/processes.
- Holds pre-bid meetings with contractors to determine the best contractor for the capital job based on safety record, knowledge of the task to be performed, experience of past performance, availability of manpower, and price.
- Evaluate pre-bid meetings and awards the bid to the contractor who is most qualified for the required task.
- Works with outside contractors to establish a project schedule to ensure construction start and completion time.
- Responsible for start-up verification and testing of projects to meet customer needs.
- Works with compliance to create an effective validation plan.
- Creates and communicates project plans, identifies milestones and critical tasks, and monitors performance against plan.
- Responsible for capital project drawings, modifications and alterations of any equipment installed to be added to any existing drawings or correct as built.
- Provides Purchasing Department with the appropriate requisitions for the purchase of labor and materials for the project.
- Responsible for maintaining and updating of P&ID systems at the site using CAD
EDUCATION AND EXPERIENCE:
- Bachelor's Degree in Engineering or equivalent is required.
- 3-5 years of production engineering experience is necessary, including responsibility for process development, operational excellence and capital projects.
TECHNICAL SKILLS REQUIREMENTS:
- Ability to independently plan and execute projects
- Ability to manage multiple tasks
- Strong interpersonal, oral and written communication skills
- Advanced mathematical, analytical and problem-solving skills
- PC literate with proficiency in Microsoft Office applications & Project software
- Excellent attention to detail
- Proven leadership skills and the ability to foster teamwork and cooperation
- Ability to lead joint vendor projects effectively
- A Green Belt in Six Sigma is desired
- Experience working in a dusty environment with explosion hazards.
- Experience in an FDA regulated facility is desired.
- Ability to read, analyze, and interpret common scientific and technical journals, financial reports, legal documents.
- Ability to write documents such as Standard Operating Procedures and PM’s, routine reports, and correspondences in a concise and clear manner.
- Advanced material and problem-solving ability
- Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
- Ability to speak effectively before groups of contractors, designers, consultants, employees, and/or senior leadership.
- Expertise in Minitab/Six Sigma is preferred.
- Must be able to access all areas of manufacturing plant.