Nature and Scope
The Process Engineer I is responsible for supporting manufacturing processes at all Ohio facilities in an FDA-regulated environment. This role serves as a Subject Matter Expert (SME) for process systems, manages capital projects, and ensures all process equipment and associated processes adhere to cGMP, company, local, state, and federal health, and safety requirements. Working as part of a multi-disciplinary team, the Process Engineer I manages multiple tasks simultaneously, drives projects from procurement through closure, and leads operational improvement initiatives. This hands-on position focuses on supporting equipment and processes for pharmaceutical manufacturing and packaging operations, serving both commercial and Research & Development needs. The ideal candidate possesses the ability to quickly grasp new concepts, chair meetings, present to leadership, and communicate professionally across all organizational levels.
Essential Duties and Responsibilities
Lead Process Utility Capital Projects
- Develop scope, budget, User Requirement Specifications (URS) and manage all phases of projects to completion including project close-out.
- Coordinate process utility support activities including equipment reconfiguration, changeover, and replacement planning Support factory acceptance testing of equipment.
- Maintain up-to-date drawings of new and existing equipment, systems and processes.
- Support preparation and maintenance of operating and preventive maintenance procedures for the process equipment to adhere to cGMPâs, company, local and state requirements.
Coordinate Handover of Process Utility Equipment from Engineering to Maintenance and Operations
- Work with engineering team to review specifications and provide input.
- Accept turnover packages and establish maintenance programs.
- Support qualification activities including protocol generation/review/execution.
- Support shutdown activities and scheduling process improvement work.
- Develop, review, revise, and maintain SOPs, operational, maintenance for all current process/packaging equipment and maintenance processes.
- Identify, generate and manage implementation of appropriate change controls to improve processes and address root causes identified in investigations in a cGMP environment.
Optimize Process Utilities/PM/Repair Program
- Prepare and maintain operating and preventive maintenance procedures for the appropriate utilities and systems.
- Develop and technically review maintenance procedures.
- Develop and review metrics on Process Utility systems.
- Support shutdown activities and scheduling of PM/repair work.
- Evaluate breakdown statistics and adjust maintenance plans to suit.
- Increase utility equipment availability through reduction of breakdowns.
- Monitor equipment operation and implement corrective actions for out of specification operation and alarms.
- Support Quality Assurance investigations of process utility issues.
- Facilitate completion of change control documentation.
- Develop training modules; provide coaching/feedback to develop/enhance technical personnel capabilities.
- Provide technical troubleshooting support to mechanics responding to breakdowns.
Education Requirements and Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
- Required
- Bachelorâs degree in engineering or equivalent work experience of at least 4 years.
- Minimum 2 yearsâ experience in a field related to manufacturing or industrial engineering, required. Pharmaceutical manufacturing, preferred.
- Ability to understand mechanical layouts and electrical/pneumatic schematics (P&IDâs).
- Must be proficient in the use of Microsoft Office Applications, including Microsoft Project, Word and Excel as well as AutoCAD.
- Hands-on ability to isolate problems and identify root cause of issues.
- Ability to clearly and concisely express thoughts in written procedures, protocols, and reports. Ability to write maintenance procedures that clearly define required tasks. Ability to proofread otherâs work for accuracy.
- Comfortable working in production environment with multiple priorities. Works effectively as a team member or as a team leader.
- Must be a creative thinker with good interpersonal relationship skills, strong project management and process improvement skills, as well as strong cross functional teamwork skills.
- Job assignments are complex in nature and require excellent planning, project leadership, technical skills, and communication to be successful in meeting project objectives. The Engineer must be able to coordinate and resolve both interpersonal and technical problems and work independently.
- Effective oral and written communication skills, acute attention to detail, excellent time and project management skills, and the drive to complete projects thoroughly. The ability to handle multiple priorities in a fast-changing work environment.
- Preferred
- 3 yearsâ maintenance experience is preferred.
- Experience with Clean Utility systems and equipment such as filters, ion exchange, Reverse Osmosis, multi-effect stills, clean steam generators, etc. Experience with Plant Utility systems and equipment such as vacuum pumps, compressors, chillers, boilers, etc.
- Understanding engineering principles as they apply to facility and production equipment.
- Understanding maintenance strategies and techniques. Understanding Continuous Improvement Principles.
- Knowledge of OSHA requirements and understanding of cGMP, GDP, and FDA requirements as applicable. Experience with regulatory interaction/auditing. Experience with Validation and Investigation Reporting.
- Knowledge of Sanitary piping principles including pipe specification, valve configuration, pump setup, etc.
- Working knowledge of Process Control and Instrumentation Systems. Working knowledge of typical office automation software suite.
- Working knowledge of statistical methods used to develop maintenance metrics.
- Role Models âcan-doâ attitude. Reinforces positive approach in daily group activities. Readily adapts to changing job duties. Establishes culture that emphasizes responsiveness.
Physical Environment and Requirements
- Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees.Â
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