Position Summary
Provide process engineering support for capital expenditures, equipment design, production equipment layouts, equipment purchases/installations, and validation/qualification for equipment and processes, plus maintenance and engineering support for the site.
Position Responsibilities
- Lead projects to develop/optimize production processes (plant design, process equipment/workflows, material handling, automation).
- Improve manufacturing processes for capacity, efficiency, and product quality.
- Support production non-conformances and attend quality review meetings.
- Investigate root cause of production issues impacting quality/yield; implement improvements and countermeasures.
- Identify sources of variation and design solutions.
- Own capital process: define user requirements, source/survey suppliers, submit RFQs, evaluate proposals, recommend purchases.
- Drive continuous improvement using engineering data/observations.
- Create validation/material qualification timelines with risk mitigations.
- Partner with support teams to improve site operations.
- Support quality control and safety standards; contribute to compliance and cost-saving objectives.
- Identify/develop/plan/implement automation opportunities and process improvement activities.
- Support site budgeting for Salisbury facility.
- Identify/write/execute/provide final summaries for validations/qualifications.
- Keep electrical/mechanical P&ID drawings updated.
- Coordinate with Regulatory & Technical groups on quality-centric improvements.
- Verify contractor-designed control schemes/interlocks/safety devices.
- Maintain DCS/PLCs in valid FDA-required state.
- Train production operators on new equipment.
- Communicate with other facilities to coordinate process developments.
- Monitor/control production output; update production/lot paperwork and quality items.
- Coordinate with Production, Quality, and Maintenance on strategies to improve potency, reduce costs, and improve process control.
Education and Experience
- BS/MS in Engineering (Chemistry, Chemical Engineering, Material Engineering and/or Biology preferred) with 5+ years manufacturing experience.
- FDA, USDA and/or Drug Product Formulation & Aseptic Manufacturing experience (required).
- Experience with dust control.
Technical Skills/Competencies Required
- Root-cause problem solving; preventative action.
- Cross-functional communication; flexibility to changing priorities.
- Proficient in Excel, Word, MS Visio, JMP, Minitab, SolidWorks (or similar).
- Ability to learn business systems (production schedule, quality deviations, ERP, change control).
- Strong attention to detail.
Physical Requirements
- Onsite work.
- Lift 50+ lbs; work near moving mechanical parts; moderate noise; eye protection required.
Compensation
- $100,000.00β$130,000.00.
Work Schedule
- MondayβFriday (standard work hours).