LinkedIn Following | |||||
"Know anyone for this job? Computer System Validation Consultant-276 in Fort Washington, PA Computer System Validation Consultant-Fort Washington,PA Contract position18 Months Send resumes to: bciociola@covexllc.com Work with the site engineering, CSV assessors, and auditors to identify, assess, and remediate legacy automation systems. • Develop standard template to ensure effective and efficient CSV program • Work with QSE-9 (Facilities, utilities and Equipment) team to develop common documents that can be used for equipment qualifications that include CSV • Assist in maintaining manufacturing systems in a validated state as they relate to CSV automation systems. • Assist with execution of validation protocols • Travel to other manufacturing sites may be required Drive completion of activities and assist the team in issues resolution Develop, maintain and report relevant metrics pertaining to performance of CSV team activities according to plan, highlight risk and assist and identifying and implementing risk mitigation activities. Perform and lead gap assessment for a variety of GxP systems Assist in developing test scenarios and aprtnering with business and QA resources for execution and approval. Education: BS in Technology related field Experience/ Technical Competencies: 3 to 5 years in pharmaceutical engineering, focusing on Computer System Validation. 3 to 5 years with pharmaceutical validation experience Strong background and experience in the Computer System Validation procedures, strategy and document development (i.e: manufacturing support systems, lab systems, PLC automation) Understand and background of enterprise wide systems and validation in GMP environment 1-3 yrs Project management experience Process Excellence Experience and certification Preferred Project management certification preferred Job Knowledge/Skillsets: • Technical writing of computer system and manufacturing equipment validations. Working with GxP systems in compliance to 21 CFR Part 210, 211, 11 (Electronic Records) and 820. • Knowledge in the following regulations and guidelines: > FDA Regulations (CFR Parts 210, 211, 11, 820 (Quality System Regulation)) > ISO Standards as applicable to Computer System Validation (ISO 9000-3) and Network Infrastructure (ISO 17799 – Security Standard) > PIC/S Guides as applicable to CGMP and Computer System Validation (Good Practices for Computerized Systems in Regulated GxP Environments) > GAMP 4 and recently revised GAMP 5, Guidelines and Testing of GxP Systems based on GAMP V-Model Framework > FDA Guidance on Software Validation (General Principles of Software Validation) > EU-GMP Annex 11 “Computerized Systems”, regulation Must have at least 3 to 5 years experience with Pharmaceutical Engineering, specializing in Computer System Validation. Independent worker. Strong organizational/facilitation/communication skills. Strong verbal, written and presentation skills. Strong sills in Interdependent partnering and influencing. Fluent in Microsoft Office suite Including ... http://bull.hn/l/11HM8/5" | |||||
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Friday, March 1, 2013
New job
New job
LinkedIn Following | |||||
"Are you a good fit for this job? Design Engineer in Clarion, IA Design Engineer 3- Location Clarion IA Our client is seeking a qualified candidate to be part of our on-site engineering team in Clarion, IA. Join a leader in the agricultural industry in providing crop protection solutions to customers. As a member of our team, you will work to design components and/or complex systems on existing products and new products. The position will require evaluation of products, parts, and processes for cost efficiency and reliability. You will work with other members of the engineering staff in a team environment to ensure that production is completed in a timely manner. This position reports to a lead product engineer, and may direct some work to others. Job Description Design: Conceive, design, analyze, and test solutions to improve cost, quality and performance of agricultural off road equipment Content may include heavy steel structures, linkages, drive systems, solution systems, and plastic components Use advanced modeling using surfacing and sheet metal applications Fluid in using mechanical engineering principals to develop robust and cost effective solutions Uses FEA analysis to understand design constraints during conceptual stage Ensures designs are effective and meet the scope of the project Ensures proper documentation of designs as required for building prototypes and for production Works with test engineer to develop test programs needed to validate designs, aids in executing tests and analysis for product verification Project Management: Create engineering specifications using sales, customer, and manufacturing inputs Ensures projects are within cost targets and delivered on time Ensures cross functional team interaction on all projects Communicates clearly and professionally to wide variety of audiences (sales, manufacturing, business leaders, customers) Experience and Skills: 4 year BS degree in Mechanical, Agricultural, or other related engineering field preferred 3 - 5 years previous experience in a machine design related position Candidate must demonstrate a proven mechanical aptitude through education, employment, or personal experience Solid understanding of hydraulic fundamentals required Experience using Solid Works is a plus Experience using simulation programs for FEA analysis is required Candidate must be able to multitask and run with several design projects simultaneously Send a word resume to jthompson@tescareers.com http://bull.hn/l/11HD9/6" | |||||
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New job Voice Systems Engineer: VoIP/SIP/Asterisk experience preferred (CT)
LinkedIn Following | |||||
Justin Sindelman posted a job: Voice Systems Engineer: VoIP/SIP/Asterisk experience preferred (CT) "Now hiring: Voice Systems Engineer: VoIP/SIP/Asterisk experience preferred | Silicon Valley style company in Connecticut http://www.ziprecruiter.com/job/Voice-Systems-Engineer-VoIP-SIP-Asterisk-experience-preferred-CT/a7d1f9f3/?source=social-linkedin-group-jobs" | |||||
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