Position Summary

This position will be responsible for providing process engineering support of all Capital Expenditures, Equipment design, Production equipment layouts, Equipment purchases and Installations, Validation/Qualifications for Equipment and Processes, as well as Maintenance and Engineering for the site. The ideal candidate will use industry best practices to measure, analyze and specify requirements that lead to best in class quality products and design for manufacturability. We are looking for a highly motivated candidate, who can work cross-functionally.

Position Responsibilities

• Lead projects relating to the development and optimization of production processes, including plant design, process equipment/workflows, material handling and automation.
• Evaluate existing manufacturing processes for improvements in capacity, efficiency and product quality in alignment with business needs.
• Support production non-conformances and attend the Quality review meetings for technical expertise and disposition of product.
• Investigates root cause of production issues impacting product quality or yield, support implementation of improvement and countermeasures.
• Identify sources of variation within the manufacturing process and design solutions.
• Develop user requirements for new capital equipment, survey potential equipment suppliers, submit RFQs, evaluate proposals from suppliers and provide recommendations for purchase. Responsible for the entire capital process and all capital expenditures.
• Recognizes need for and embraces concept of continuous improvement. Creates new ideas and recommendations based on engineering data, facts, and observations. May lead improvement tasks depending on their scale.
• Create project timelines for validations/material qualifications that include risk mitigations to achieve required timelines.
• Effectively partners with and motivates enabling support teams to improve operations for the advancement of the whole site and company.
• Support quality control and safety standards.
• Actively contribute to meeting business objectives around compliance, cost savings, and potentially capital spend requirements.
• Identify, develop, plan, and implement Automation Opportunities for the site
• Identify, develop, plan, and implement Process Improvement activities across the site.
• Learn, and Understand the site Budgetting process for the Salisbury facility
• Identify, Write, Execute, and provide Final Summary for all Validation and Qualifications for the Salisbury facility.
• Have all Electrical and Mechanical P&ID drawings updated to our current state.
• Work closely with the Regulatory & Technical groups to develop Quality centric process Improvements for the site.
• Verify control schemes, interlocks, and safety devices designed by contractors
• Maintain Distributive Control Systems and Programmable Logic Controllers in a valid state as required by the FDA
• Train Production Operators in the proper operation of new equipment
• Communicate with individuals at other facilities to coordinate process developments
• Monitor, improve, and control Production output for each line to ensure that plant goals are achieved.
• Responsible for updating all paperwork for the Production area, from daily output to lot specific batch sheets (when needed) as well as all Quality related items.
• Coordinate with Production, Quality, and Maintenance Departments to develop strategies to increase production, such as: improvement of potencies, reduction of costs, and process control.
• Other duties may be identified and assigned as necessary

Education and Experience

• BS/MS in Engineering (Chemistry, Chemical Engineering, Material Engineering and/or Biology preferred) with 5+ years of experience in a manufacturing environment.
• Food and Drug Administration, USDA and/or Drug Product Formulation & Aseptic Manufacturing experience is required.
• Experience with Dust Control

Technical Skills and Competencies Required

• Strong ability to do root-cause problem solving, and implementation of effective preventative action.
• Able to interact effectively with all levels of colleagues and management across organizational boundaries.
• Possess flexibility and agility to respond to constantly changing conditions and priorities.
• Proficient computer skills such as Excel, Word, MS Visio, JMP, Minitab, Solid Works, or similar software.
• Must be willing to quickly learn and become proficient in common systems used to manage the business – to include production schedule, quality deviations, ERP system, and change control.
• Strong attention to detail

Physical Requirements:

• Colleague must work onsite.
• Able to lift at least 50 pounds, and work near moving mechanical parts with moderate noise level where the use of hearing protection is optional and eye protection is required.
• Standard work hours based on the needs of the facility.