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Commissioning Engineer (Waco Texas) Ad id: 207137776039824 |  Views: 165

Price: Contact Us
Date listed: 6 years ago
Commissioning Engineer (Waco, Texas) Are you looking for a meaningful career that makes a difference in the world? Then consider joining the Hyde Engineering + Consulting team where you will do just that. Hyde E+C contributes to helping people live longer, healthier lives by ensuring pharmaceutical and biopharmaceutical manufacturers are able to effectively and safely produce their life enhancing and often life saving medicines. At Hyde E+C we want to attract the industry's best and brightest to help us achieve our vision to be the premier Biopharma Process Engineering, Validation and Regulatory Compliance Solution Provider in all Markets. To do so, we offer competitive compensation, excellent benefits and a strong commitment to work/life balance. At Hyde E+ C you will find these values reflected in our company:• Family Happiness• Integrity• Friendship• Wisdom• Adventure Since 1993, Hyde E+C has worked as an integral part of project teams for clients and equipment vendors resulting in the successful construction, commissioning and validation of facilities and equipment. At Hyde E+C we provide high value engineering, compliance, qualification and automation solutions to the Biopharmaceutical and Biocommodity industries. Our knowledge and experience of the industry, as well as our in-depth understanding of the regulatory FDA/EMEA risk based management approach, provides added value for our clients both within the US and globally. Our offices are located: Domestically--California, Colorado, North Carolina, Pennsylvania, and Massachusetts; Internationally--Ireland, India, and Singapore. Note: The following description describes typical duties and responsibilities and is not intended to limit management from assigning other work as desired. This document does not create an employment contract, implied or otherwise, other than an "at will" relationship. GENERAL PURPOSE/SUMMARY The Commissioning Engineer is a professional who understands lean manufacturing concepts, can implement continuous improvement and support production. Must be able to accomplish projects independently, exceed targets and timetables, remain on task and optimize results. Strong work ethic is essential. In this case, we are looking specifically for individuals with experience and expertise in Commissioning & Qualification. Responsibilities of such a role include generation of protocols and reports in addition to executing qualifications of equipment, facilities, and utilities. Other duties may include cycle development for cleaning and sterilization processes. Those candidates at the senior level will perform all of the above duties with ease while also being able to generate and maintain the C&Q plans, manage peers or a team, and approve or review of all documentation. ESSENTIAL DUTIES AND RESPONSIBILITIES• Performs the design and implementation of chemical processes, instrumentation and equipment. • Provides expertise in cell culture, engineering, design and process and/or scale-up. Assists the manufacturing operation in problem solving with regards to equipment and systems. • Develops and recommends new process formulas and technologies to achieve cost effectiveness and improved product quality.• Conducts research/literature searches of current synthetic chemicals.• Establishes operating equipment specifications and improves manufacturing techniques. • Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors.• Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. KNOWLEDGE, SKILLS, AND REQUIREMENTS Basic Requirements• Knowledge and experience working under GMPs.• Knowledge of ICH Q8, Q9, Q10 and other international regulatory guidelines• Proficiency in Microsoft Office products, AutoCAD or equivalent• Strong verbal and written communication skills Commissioning & Qualification:• Knowledge of utilities, facilities and systems• FATs, SATS and Turn Over Packages• Knowledge of Commissioning Lifecycle Approach• Risk based approach tools (FMEA, etc.) Engineering: • Client consultation regarding technical approaches to project• P&IDs and Functional and Detailed Design Specifications review and development• Clean water systems, CIP, SIP, and process equipment Controls: • The design, programming, testing and start-up of PLCs, SCADA and HMI interfaces, and integrated systems• DCS, Delta V and BAS QUALIFICATIONS• BS in Engineering (e.g., Chemical, Mechanical or Industrial preferred), Natural Sciences (e.g., Microbiology, Biology, or Chemistry); or (e.g., Business) may be acceptable when supplemented with technical work experience.• Minimum 3 -- 5 years of industry experience related to GMP drug manufacturing, process design, commissioning and qualification; 10+ years for Senior Level• Minimum 5 - 7 years of experience in equipment, process or clean utility systems Please reply directly to careers@hyde-ec.com Location: Waco Texas Compensation: CompetitivePrincipals only. Recruiters, please don't contact this job poster.Please do not contact job poster about other services, products or commercial interests.
 


 
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