SanClementeRecruiter Since 2001
the smart solution for San Clemente jobs

Senior Engineer, IT Software Validation

Company: CTI Education Group
Location: San Clemente
Posted on: February 24, 2021

Job Description:

Connect to a Career That Makes a Difference Job Description - Senior Engineer, IT Software Validation (21300124) Job Description Senior Engineer, IT Software Validation - ( 21300124 ) Description Senior Engineer, IT Software Validation - San Clemente, CA Responsibilities The senior quality validation engineer is responsible for CVS support for computerized systems, networks and software that have been newly installed, upgraded and/or modified to support CGMP functions in manufacturing, supply chain, and quality. As part of it quality and compliance organizations. Work closely with validation change owners to generate and execute validation documents (IG, OG, IOG, PQ etc.) that are compliant with plant and corporate policies and procedures. Ensure proper execution/documentation of test results, and compilation of validation packages. Responsible for reviewing, executing and approving validation documents, and if necessary manage contract resources to generate and/or execute validation documents and activities. Ensure validation packages contain all relevant information, rationales, references, and data to support the change and that all reports and protocols are reviewed and approved as appropriate. Initiates, leads and authors CGMP risk assessment, gap analysis, and deviation management associated with validation programs with precise document writing following good documentation practices (CDP) with clarity to meet the set forth expectations ensure validation plans and strategies are in alignment with validation policies, procedures and guidelines and external regulatory requirements, and European and international standards interact with GA, IT, engineering and business area users to understand functionality and use of automated control systems review and provide feedback to plant and corporate policy writers on CSV guidelines, specifications and policies coordinate tasks with validation technician(s) and validation consultants to provide project and technical direction, as needed must be able to manage complex projects, set/achieve timelines, direct/redirect resources and manage assigned funding. Plan and lead revalidation of computer systems own tasks related to periodic reviews, and remediation activities on validated systems. Plans and/or executes these validation protocols participate on investigation teams in the event of adverse validation trends/failures to identify root cause and corrective/preventative actions. Expected to bring validation expertise and strong analytical and systematic problem-solving skills. Write or assist with the writing of standard operating procedures, business/software requirements and validation master plans must maintain a thorough working knowledge of the ICU Medical systems and validation requirements must be able to work extended schedules as required to meet deadlines work on special projects as they arise. EDUCATION AND EXPERIENCE REQUIREMENTS: Master's degree (or foreign equivalent) in Computer Science, Management Information Systems, Information Technology, or a closely related field, plus three (3) years of experience in the job offered or a closely related field OR a Bachelor's degree (or foreign equivalent) in Computer Science, Management Information Systems, Information Technology, or a closely related field plus four (4) years of experience in the job offered or a closely related field. SPECIAL REQUIREMENTS:
Must possess expertise/knowledge sufficient to adequately perform the duties of the job being offered. Expertise/knowledge may be gained through employment experience or education. Such expertise/knowledge cannot be "quantified" by "time." Required expertise/knowledge includes: Experience and functional knowledge of good automated manufacturing practice (GAMP), CGMP, SDLC, Risk assessment, EU Annex11 and 21 CFR part 11 electronic records and electronic signatures; Oracle Agile PLM; Oracle EBS; Experience in one of the following: Manufacturing, Facilities/Utilities, Pharma/Solution Processes, Sterilization, IT Applications and/or Controls Systems/Software; Data Migration and Data Modelling Techniques; and at least three (3) years of validation engineering experience.-- ICU Medical, Inc. is an equal opportunity employer. To apply for ICU Medical's Senior Engineer, IT Software Validation position please send resume to:-- ICU Medical, Inc.
Attn: Ricci Chila, HR Business Partner
951 Calle Amanecer
San Clemente, CA 92673
Must reference JOB CODE: CA0420PP EOE M/F/D/V
It is the policy of ICU Medical, Inc. to afford full equal employment opportunity to qualified employees and applicants, regardless of their race, color, religion, sex, national origin, age, physical or mental handicaps, military or veteran status, sexual preference, or any other protected condition or characteristic in conformity with all applicable federal, state and local laws and regulations.
--

Keywords: CTI Education Group, San Clemente , Senior Engineer, IT Software Validation, IT / Software / Systems , San Clemente, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other IT / Software / Systems Jobs


CRM Technical Consultant
Description: OverviewAt Perficient you'll deliver mission-critical technology and business solutions to Fortune 500 companies and some of the most recognized brands on the planet. And you'll do it with cutting-edge (more...)
Company: Perficient
Location: National City
Posted on: 03/2/2021

Senior Software Engineer, iOS
Description: Tapcart makes mobile shopping app easy, fun and attainable for every brand. The world of shopping will one day be powered entirely by mobile, made possible by our products, team and vision. We are inspired (more...)
Company: Tapcart
Location: Santa Monica
Posted on: 03/2/2021

SAP FICA-CI / BRIM / Hybris Consultant
Description: Job Title: SAP FICA-CI / BRIM / Hybris consultantDuration: 12 Months Possibility of Long Term Extension Location: 100
Company: Collabera
Location: Burbank
Posted on: 03/2/2021


Product Tester (from home) - Part-Time, No Exp Req. $25-$45/hr
Description: American Consumer Panels reg , located at One World Trade Center, 285 Fulton St., Suite 8500 New York, NY, 10007, is looking to fill the position listed below nationwide : br br In-Home Usage Tester (more...)
Company: American Consumer Panels
Location: Newport Beach
Posted on: 03/2/2021

Senior Software Engineer, Multiplayer
Description: Who We AreAt Visual Concepts, we believe great games are made by diverse and empowered teams with a shared passion for play. As one of the world's top game development studios, we have shipped over 100 (more...)
Company: Visual Concepts
Location: Lake Forest
Posted on: 03/2/2021

Senior IT Audit Manager
Description: If you are a Senior IT Audit Manager with experience, please read on br br Based out of Orange County, we are a leader with 30 years of experience in providing, IT Audit, Compliance, Risk Management, (more...)
Company: CyberCoders
Location: Costa Mesa
Posted on: 03/2/2021

Saba Learning System Administrator
Description: Our Client is an active partner in the entertainment industry. Currently, they are looking for a talented Saba System Administrator. The need is for the administrator to work 20 hours a week remotely (more...)
Company: Careerbuilder-US
Location: Santa Monica
Posted on: 03/2/2021

Sr Principal Windows Systems Administrator
Description: Support our entire enterprise and build the networks, staff the teams, and develop the processes that will keep us defining what's possible. We have opportunities across our enterprise with 90,000 team (more...)
Company: Northrop Grumman
Location: Gardena
Posted on: 03/2/2021

Field Service Technician
Description: Field Service Technician Problem Solvers, Techies, and Challenge Seekers, this job is for you. When we say it works we have our Field Service Technicians to thank. If you're handy, enjoy variety, and (more...)
Company: CSC Service Works
Location: Inglewood
Posted on: 03/2/2021

Sr Principal Windows Systems Administrator
Description: Support our entire enterprise and build the networks, staff the teams, and develop the processes that will keep us defining what's possible. We have opportunities across our enterprise with 90,000 team (more...)
Company: Northrop Grumman
Location: Inglewood
Posted on: 03/2/2021

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

San Clemente RSS job feeds