E-Technologies Group Background

E-Technologies Group is a project-based engineering consulting firm. Our key disciplines are automation, controls, information technology, validation, and regulatory compliance. We have been providing high-value services for all project phases since 1993. Our focus is on creating valuable, high quality solutions for our clients to help them meet both their current and long-term business objectives. The commitment of our highly qualified and experienced staff to the needs of our clients is the foundation of our business, earning us a high degree of customer loyalty.

Our headquarters in West Chester, Ohio, is conveniently located about 15 miles north of Cincinnati and 35 miles south of Dayton. Our modern facilities include a training center and a fully equipped lab and staging area. E-Tech strives to be the best company to work for, offering competitive pay and an outstanding benefits package. Our recent achievements include being named a Top 100 consulting firm by Inc. magazine and one of Greater Cincinnati’s “Fast 55” companies, a ranking of the region’s fastest-growing companies.

Position Description

E-Technologies Group is seeking to fill a direct hire position for a Lead Validation Project Engineer. Essential job duties include leadership of teams in the development, review, approval, and execution of validation documentation including VP, Trace Matrices, IQ, OQ and Summary Reports to maintain processes, systems, and equipment in a validated state per URS and DDS information. This position also requires providing guidance and training to internal and external departments on the development and execution of validation protocols. Ideal candidates will have some combination of the following skill sets.

All candidates should meet the following minimum requirements:

• BS or MS in Engineering, computer sciences or physical/life sciences or equivalent experience

• Computer System Validation Project Management/Leadership experience

• Must have minimum 7 years experience in leading the validation of and/or validating automated/PLC controlled equipment and processes

• IQ and OQ documentation development and execution on Automated Systems

• Ability to read/interpret electrical schematics, P&ID’s, AF&ID’s, and related design material

• Understanding of Project Scope, Schedule and Budget development with Project Forecasting and Reporting for successful project implementation is desirable

• Knowledge of cGxP requirements

• Self starter with excellent written and oral communication skills

• Ability to manage personnel and projects while exercising excellent decision making and time management skills

Desirable attributes include:

• GAMP 5/SDLC expertise

• Working knowledge of 21 CFR Parts 210 and 211, and 21 CFR Part 11

• Integrated C&Q methodology experience

• PLC/HMI/Batch programming experience

• SOP development experience

• Experience with validating: CIP & SIP Processes, RSBatch recipes, Filling Lines and/or Packaging Lines