-
Software Validation Engineer
2 weeks ago
Planet Pharma Libertyville, United StatesSUMMARY · 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 co ...
-
Validation Engineer
1 week ago
AbbVie North Chicago, United States· Company 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 a ...
-
Validation Engineer
6 days 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 ...
-
Software Validation QA Engineer
2 weeks ago
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 ...
-
Computer System Validation Engineer
10 hours 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 ...
-
Validation Engineer
1 week 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 ...
-
Validation Engineer
1 week 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 ...
-
Validation Engineer
1 week 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 ...
-
Validation Engineer
14 hours 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 ...
-
Validation Engineer
6 hours 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 ...
-
Validation Engineer IV
1 week 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 ...
-
Validation Engineer
1 week ago
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 ...
-
Validation Engineer
1 week 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 ...
-
Validation Engineer
10 hours 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 ...
-
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 ...
-
sr validation engineer
1 week ago
Fresenius Kabi Melrose Park, United StatesJob Summary · Responsible for providing technical support to operations in terms of initial · equipment/facility/utility · qualifications and · equipment/facility/utility · requalifications. Will participate in process and equipment improvement teams charged with enhancing t ...
-
sr validation engineer
1 week ago
Fresenius Kabi AG Melrose Park, United StatesJob Summary · Responsible for providing technical support to operations in terms of initial equipment/facility/utility qualifications and equipment/facility/utility requalifications. Will participate in process and equipment improvement teams charged with enhancing the complianc ...
-
sr validation engineer
1 week ago
Fresenius Kabi USA, LLC Melrose Park, United StatesJob Summary Responsible for providing technical support to operations in terms of initial equipment/facility/utility qualifications and equipment/facility/utility requalifications. Will participate in process and equipment improvement teams charged with enhancing the compliance a ...
-
Sr. Validation Engineer
1 week ago
Fareva Morton Grove Morton Grove, United StatesThis job was posted by : For more information, please see: · Page 1 · POSITION DESCRIPTION · POSITION TITLE: · Senior Validation Engineer · POSITION GRADE · JOB CODE Exempt · REPORTS TO POSITION TITLE: Sr. Quality Manager · DATE LAST UPDATED August 2023 · PEOPLE MANAGER (YES) ( ...
-
Senior Quality Validation Engineer
1 week ago
FAREVA Morton Grove, United StatesSenior Quality Validation Engineer · Fareva is currently seeking an experienced Senior Quality Validation Engineer to join our team in Morton Grove, IL. · Overview · This position is responsible for managing the Sanitization Program for the site. Position requires knowledge of Cl ...
Computer System Validation Engineer - Libertyville, United States - TechDigital Corporation
Description
PURPOSE 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 and higher-level customers as well as external service providers.
Reporting into the site Digital Plant organization the candidate will be primarily responsible for managing IT deviations, CAPAs, Investigations, Change Management, computer system validation in support of the vector manufacturing site.
The candidate should have at least 5+ years of experience in pharma/biotech with specific expertise in Supply Chain, Manufacturing, and Quality System disciplines.
The candidate needs to understand shop floor activities, Good Manufacturing Practices (GMPs), electronic change management, and process automation in addition to prior manufacturing systems development and support.
DUTIES AND RESPONSIBILITIES:
Support the IT Quality & Compliance for the Cell Therapy Vector manufacturing site.
Take ownership of deviations, CAPAs and investigations involving the Manufacturing IT Systems.
Open and lead investigations, triage deviations, and ensure CAPAs are addressed and implemented per requirements.
Engage technical experts as needed to author and present change requests and author investigations write-ups.
Support Health Authority and internal audits.
Collaborate and support the other Site IT groups (Manufacturing IT Systems & MES, Operational Technology Systems & Automation, Enterprise Systems and Integration, IT Site Shared Services) to ensure we can correctly support the manufacturing site.
Provide support for operationalizing the manufacturing and peripheral systems.
Responsible for Computer System Validation of local/site-based systems
Accountable for the continued compliance of IT systems, procedures and training for vector manufacturing and lab systems.
REQUIRED COMPETENCIES:
Knowledge, Skills, and Abilities:
Ability to effectively communicate with both technical and non-technical team members.
Strong interpersonal skills, especially regarding team work, client focus, verbal and written communication
Knowledge of industry standard Quality and Compliance methodology to ensure our IT systems deliver the intended performance and ensure they meet regulatory requirements.
Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Biologics and clinical manufacturing.
Knowledge of IT service management platforms to support incident, problem and change IT operational events (i.e. ServiceNow).
Knowledge and exposure to Business Quality Management Systems (i.e. Veeva).
Strong technical and problem-solving skills and the ability to work independently.
Demonstrated success working in a high-performing, business results-driven environment.
Understanding of computer system validation.
Familiarity with MES systems (i.e. Emerson Syncade), DCS systems (i.e. Emerson DeltaV, ERP systems (i.e. SAP or Oracle), EBRs (i.e. InfoBatch) and Historians (i.e. OSIsoft PI).
Understanding of computer system validation (CSV).
Education and Experience:
Bachelor's degree in an engineering or MIS discipline.
Must have experience with IT Quality & Compliance applications and systems in a bio-tech manufacturing environment.
Must have 5+ years of hands-on experience in a biotech manufacturing and supply chain environment.
Understanding of supply chain, manufacturing domains and supporting technology including manufacturing and supply chain ERP systems (e.g. Oracle, SAP).
Working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP.
Sound understanding of Electronic Batch Records (EBR) and Review by Exception (RBE).
#J-18808-Ljbffr