Works with respective functional group in developing and implementing project scope and cost estimates. Works with respective functional group(s), incorporating business data (sales, financial, etc.) where appropriate, to generate a compelling project justification and application for approval of funds. Works with all internal stakeholders to develop User Requirement Specifications (URS) for equipment. Assists Validation Department with developing, reviewing, approving and executing IQ, OQ, PQ, FAT, SAT, equivalency, change in kind documentation as required in the pharmaceutical environment while ensuring compliance to all applicable standards related to the technology including federal, state, and local regulatory codes, as well as customer, operations and corporate requirements. Execute change management process documentation. Manage the work of project contractors/vendors. Ensure proper end users training for all projects. Writes and executes Risk Analysis (i.e. FMEA and Fishbone Diagrams) and Engineering Change Orders. Utilizes continuous improvement methodology to improve internal processes. Writes/revises SOPs, User Requirement Specs, Functional Requirement Specs, Design Specs, Qualifications, etc. Provides engineering support to corrective actions and deviations by identifying root cause and offering solutions. When necessary, assist the Maintenance Department in resolving high-level technical processing issues related to equipment operation. When assigned act as Engineering Department representative on Site wide teams, e.g. safety. All other duties as assigned.Education:Bachelor's degree in engineering discipline preferred, or equivalent technical experience as determined by the hiring manager.Experience:Four (4) plus years engineering experience in pharmaceutical manufacturing environment or other regulated industry.Other Skills/Competencies:Familiarity with ISPE accepted Good Engineering Practices, and scientific terms, principles and concepts required.Ability to read & interpret AutoCAD electrical, mechanical schematics, P&ID drawings.Experience with FDA, NFPA and OSHA codes and regulations.Working knowledge of MS Word, Excel, PowerPoint, MS Project etc. Able to work both independently, within a team, and able to organize and lead a team.Strong organizational skills.Strong verbal and written communications skills and ability to communicate clearly and efficiently.Compensation Range: $75,988.00 – 103,580.00 + Bonus + Relocation Assistance + Benefits from day one + Generous 401K match.#J-18808-Ljbffr
