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Validation Engineer
2 weeks ago
AbbVie North Chicago, United StatesCompany Description · AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic area ...
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Validation Engineer
3 weeks ago
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Validation Engineer
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Sterling Engineering North Chicago, United StatesJob Description · Job Description · Job Overview : · The Validation Engineer will be responsible for the commissioning, validation, and qualification of equipment, facilities, and utilities within a pharmaceutical manufacturing environment. This role will be Temperature Mapping ...
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Software Validation QA Engineer
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Planet Pharma Libertyville, United States(This is a hybrid 6-month contract, with potential to extend/convert, available for candidates local to the Libertyville,, Il area) · SUMMARY · The primary purpose of the Software Validation Engineer - Contingent Worker role is to support delivery of global software validation pr ...
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Computer System Validation Engineer
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TechDigital Corporation Libertyville, United StatesPURPOSE AND SCOPE OF POSITION: · The Manufacturing IT Systems Quality & Compliance Specialist Cell Therapy Manufacturing Systems supports the successful operation of manufacturing and business functions at Libertyville site through interaction with internal team members, peer an ...
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Computer System Validation Engineer
1 week ago
TechDigital Corporation Libertyville, United StatesPURPOSE AND SCOPE OF POSITION: · The Manufacturing IT Systems Quality & Compliance Specialist– Cell Therapy Manufacturing Systems supports the successful operation of manufacturing and business functions at Libertyville site through interaction with internal team members, peer an ...
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Validation Engineer
3 weeks ago
Triunity Software Round Lake, United StatesWhat are you top three to five technical skills requirements? · •Tech savvy person- hands on person, not afraid to learn or use computerized systems and equipment. Proficient in word, excel, and PowerPoint. · •Basic knowledge GMP and basic understanding of validation and pharma ...
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Validation Engineer
1 week ago
Triunity Software Round Lake, United StatesJob Description · Job DescriptionWhat are you top three to five technical skills requirements? · Tech savvy person- hands on person, not afraid to learn or use computerized systems and equipment. Proficient in word, excel, and PowerPoint. · Basic knowledge GMP and basic understan ...
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Validation Engineer
3 weeks ago
Automated Systems Round Lake, United StatesJob Description · Job Description · Validation Engineer · Contract: · 6+ months duration with possible extensions · Location : Round Lake, IL · ONSITE · Sponsorship is not available for this role now or in the future · Job Summary · Automated Systems, Inc. is looking for a Va ...
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Validation Engineer
3 weeks ago
Katalyst Healthcares and Life Sciences Round Lake, United StatesResponsibilities: Be involved in design of experiments, development of new methodologies and improving existing methodologies, data generation, report development and presentation. · Schedule, plan, communicate, and manage documents and follow-up on validation activities. Inter ...
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Validation Engineer
1 week ago
Katalyst HealthCares & Life Sciences Round Lake, United StatesResponsibilities: Be involved in design of experiments, development of new methodologies and improving existing methodologies, data generation, report development and presentation. · Schedule, plan, communicate, and manage documents and follow-up on validation activities. Inter ...
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Validation Engineer
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BWI Chassis Dynamics (NA) Inc. Moraine, United StatesBWI Group · is a global automotive Tier-1 supplier with a legacy spanning more than a century and with the vision of Empowering Smart Mobility. We deliver safe, comfortable, smart, and sustainable ride and drive solutions with our Brake and Suspension System products from our lo ...
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Validation Engineer IV
3 weeks ago
Katalyst Healthcares and Life Sciences North Chicago, United StatesResponsibilities: Maintaining the integrity of the client Quality System · ct as a single point-of-contact to interface with Client division customers · Develop and manage documentation for engineering studies ( "ES"). Execute ES activities. · Develop and manage documentation ...
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Validation Engineer
3 weeks ago
Sterling Engineering Westchester, United StatesJob Description · Job Overview: · The Validation Engineer will be responsible for the commissioning, validation, and qualification of equipment, facilities, and utilities within a pharmaceutical manufacturing environment. This role will be Temperature Mapping and updating old do ...
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Validation Engineer
1 week ago
Sterling Engineering Westchester, United StatesJob Overview: · The Validation Engineer will be responsible for the commissioning, validation, and qualification of equipment, facilities, and utilities within a pharmaceutical manufacturing environment. This role will be Temperature Mapping and updating old documentation to new ...
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Healthcare Businesswomen's Association Mundelein, United StatesJOB SUMMARY: · Under limited supervision, lead verification and validation activities related to medical device product packaging. Ensure regulatory compliance by inspecting, measuring, analyzing, auditing, calibrating and testing instrumentation, equipment, software/hardware, ma ...
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Medline Industries Mundelein, United StatesEDUCATIONBachelor%26rsquo;s Degree in Engineering or equivalent knowledge. · WORK EXPERIENCE At least 4 years with verification or validation testing. · KNOWLEDGE / SKILLS / ABILITIESExperience analyzing and reporting data in order to identify issues, trends, or exceptions. · Exp ...
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Sr validation engineer
5 days ago
Randstad Morton Grove, United Statesjob summary: · Randstad is the #HR Solutions company in the world and we are sourcing for a Sr Validation Engineer in the Suburbs of Chicago, IL. This position is responsible for managing the Sanitization Program for the site. Position requires knowledge of Cleaning, Sanitization ...
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sr validation engineer
1 day ago
Randstad Morton Grove, United Statessr validation engineer. · morton grove , illinois · posted 7 days ago · job details · summary · $80,000 - $100,000 per year · permanent · bachelor degree · category life, physical, and social science occupations architecture and engineering occupations · reference48177 · j ...
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Sr Validation Engineer
1 week ago
Randstad North America, Inc. Morton Grove, United States. Plans, implements a robust cleaning and sanitization program by authoring and leading the sanitization Validation Program for all products and product contact equipment. · . Leads the execution of the cleaning and sanitization vali Validation Engineer, Validation, Engineer, Cle ...
Software Validation Engineer - Libertyville, United States - Planet Pharma
Description
SUMMARY
The primary purpose of the Software Validation Engineer is to support delivery of global software validation projects in collaboration with IT and system owner cross functional teams. This role represents the quality (GQRA) function for the software project to ensure compliance with global software procedures, software standards, and regulations with regards to validation and documentation controls. The position has direct involvement with the introduction and maintenance of global software systems utilized to support GMP manufacturing.
Reporting to the Global Validation Manager, this role is responsible for being the quality representative for computer system validations, development and execution of validation plans, protocols, and testing documentation for compliant computerized operations in a GMP environment. The role will support the establishment of standard work practices and testing for the validation and ongoing maintenance of computerized systems and will support investigations, resolve potential data integrity issues, and implement process improvements to mitigate any risks to the validated state.
RESPONSIBILITIES
• Ensure all Computerized system applications are qualified in compliance with company policies and procedures, FDA, European cGMP, and GAMP standards
• Co-ordinate, provide guidance and actively participate as a project team member for software validation projects
• Generation/maintenance of software validation plans, protocols, and reports to cGMP standard
• Review / approval of software validation plans, requirements, protocols/ test scripts and final reports
• Management of software validation change control process.
• Serve as validation SME providing guidance and direction to lead validation activities for software projects
• Represent validation team at both internal and external audits and at Quality System Management Reviews when applicable
• Responsible for the overall administration of the document control program related to software validation
ESSENTIAL FUNCTIONS OF THE ROLE
• Strong communication skills both verbal and written
• A high level of attention to detail, to ensure accuracy and full compliance with procedures
• Strong work ethic and an ethos of Right-First-Time
• Total commitment to quality and maintaining a high standard of work at all times
• Strong interpersonal skills
• Strong leadership skills with the ability to influence change when needed
• Good project management skills including organization and planning
• Ability to work independently and remotely with minimum direct supervision
WORK EXPERIENCE REQUIREMENTS
• Number of Overall Years Necessary: 2-5
• Experience working with computer systems, software validation, or related field is essential
• Computer Systems Validation experience and understanding of applicable regulations (Annex 11, GAMP, 21 CFR Part 11)
• Regulated environment, medical devices experience is preferable
• Previous people management (direct or indirect) experience is preferable
EDUCATION REQUIREMENTS
• Bachelor's Degree in a scientific or engineering discipline required
SPECIALIZED SKILLS / TECHNICAL KNOWLEDGE
• Good knowledge and understanding of the medical device quality and/or regulatory requirements, including ISO13485, GAMP 5, IEC62304, 21CFRpart 820, part 11 as well as other Computer System Validation processes
• Demonstrated working knowledge in the principles and effective implementation of software validation methodology
• Experience in the review, evaluation and testing of systems to ensure compliance with FDA Electronic Records/Electronic Signatures regulations
• Good overall knowledge with IT infrastructure and applications
• Strong oral, written communication, and interpersonal skills
• Ability to work closely with people at all levels of the organization and with persons from different cultural, language and regional backgrounds to accomplish assigned project goals
• Must be results driven striving to meet all targets and prioritize/manage project deliverables
• Experience interacting with auditors preferred
