- GNC (Greenville, SC)
- …Application Security, Data Security, Infrastructure Security, Software Security Practices, Compliance to FDA 's Computer Systems Validation Code (21 ... due diligence across GNC's entire Supplier base. This includes developing risk management systems to evaluate and assess each supplier so that appropriate levels of… more
- Capgemini (Nashville, TN)
- **Title: Computer System Validation (CSV) Specialist** **Location: Nashville TN** **Duration: Full Time** **Job description:** Responsible for all ... reliable over its lifecycle. + Create and manage the computer system validation strategy and...change control procedures for any changes made to validated systems , ensuring that the system is re-validated… more
- PCI Pharma Services (Bedford, NH)
- …and guidelines (eg FDA , MHRA Data integrity guidelines, etc.) around quality systems and computerized system validation in Biotech and/or Pharmaceutical ... with departments inside the organization to maintain and improve computer system validation processes to...skills. **EXPERIENCE** + At least 3+ years of relevant computer systems validation systems… more
- Robert Half Technology (New Haven, CT)
- …skills in GxP and GxP FDA . * Proficiency in handling Computer Systems and System Validation . * Experience in Compliance Risk management related to ... entire System Development Life Cycle (SDLC) of computer systems , ensuring validation is...IT systems . * Familiarity with FDA 21 CFR… more
- Boehringer Ingelheim (Athens, GA)
- …staff and other departments. + Leads and actively supports strategic direction of validation philosophies, improve overall validation system and process flow ... effort and is responsible for assuring compliance of validated systems , process, equipment to current cGMP, FDA ,...(VMP) and Corporate Policies and Procedures. + Maintains site validation database and document systems , supports feasibility… more
- Catalent Pharma Solutions (Harmans, MD)
- ** Computer Systems Validation Engineer**...to 21 CFR Part 11 compliance requirements and Global Computer System Validation and ISPE ... involved in processing steps related to equipment, facility/utility and computer systems validation . This role...Author and Review of Validation Deliverables - Validation Master Plan (VMP), System Impact Assessment,… more
- Medtronic (OR)
- …service, and repairs. + Experience implementing and adhering to FDA and computer systems validation requirements. + Demonstrated leadership in achieving ... + Conduct thorough IT due diligence to understand the technology infrastructure, systems , applications, and data of both acquiring company and acquisition target.… more
- Mentor Technical Group (Gurabo, PR)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... Belt). + Project management and/or project owner experience. + Process and CSV validation knowledge. Mentor Technical Group es un empleador que ofrece igualdad de… more
- Fujifilm (College Station, TX)
- …Life Sciences, Engineering, or similar discipline with 7+ years of experience in computer system validation activities in pharmaceutical, biotechnology, or ... Plans (VPPs), System Impact Assessment (SIAs) and drafting and executing validation protocols for Facilities, Utilities, Systems and Equipment (FUSE), as… more
- Bio-Techne (St. Paul, MN)
- …+ A background in pharmaceutical science or engineering, and equipment/computerized system validation is advantageous. Knowledge and understanding of ... key to our business. You have the opportunity to be part of this system . **Key Responsibilities:** + Responsible for the validation studies required for… more
- Kelly Services (Eagan, MN)
- …Process Performance Qualification and Process Validation requirements. + Knowledge of Computer System Validation and Cleaning Validation ... and Process Validations. + Execute Cleaning Validations. + Implement Computer System Validations. + Develop, update, and...expertise in developing, executing, and maintaining validation systems . + Strong understanding of cGMP, FDA … more
- Unither Pharmaceuticals (Rochester, NY)
- …the Validation Document Library, maintains test equipment and documentation system . ESSENTIAL FUNCTIONS / RESPONSIBILITIES: Assists in the execution of ... products and surface swabbing for testing as outlined by validation /qualification protocols. Maintains protocols and system documentation in… more
- Kelly Services (Minneapolis, MN)
- …Utility, Equipment, and Process Performance Qualifications, as well as Cleaning and Computer System Validation programs. + **Collaboration & Support** ... Expertise** : Proven track record in developing and executing robust validation systems across multiple domains, including equipment, processes, cleaning, and… more
- Curia (Burlington, MA)
- … validation and revalidation protocols for processes, equipment, utility, and computer software validation . Work with Engineering and Facilities personnel to ... ensure proper installation and operation of systems prior to and post- validation . Provide technical... Validation tools and processes, which include waterfall, validation life cycle, and V-Model; * FDA … more
- Philips (Cambridge, MA)
- …in validation of enterprise-wide quality IT systems using established Computer System Validation (CSV) methodology + strong knowledge of working ... As a Quality Management Systems Software Validation Engineer, you will...effective and compliant, while supporting the deployment of Non-product System Software validation process in the local… more
- Curia (Albuquerque, NM)
- …equipment and manufacturing process protocols and final report. + Review and approve validation protocols for computer related systems (as needed), ... validation protocols for processes, equipment, utilities, and test systems . The role also supports new product introductions, equipment...the review of changes made under the Change Control System from a validation perspective + Provide… more
- VTI Life Sciences (Los Angeles, CA)
- …quality systems and participates as subject matter expert of validation requirements. The scope includes validation for Facility, Equipment, Critical ... and support for the development (or modification phases) of manufacturing facility, systems , process and information and Computerized System ; address, include… more
- United Therapeutics (Silver Spring, MD)
- … Datalogger Software (preferably Amphenol / Ellab) + Ability to perform validation activities for equipment, process and/or computer -related validation ... by either overseeing or else providing hands-on assistance during testing to either System Owners or Validation management + Ability to interact and communicate… more
- Actalent (Irvine, CA)
- … protocols + Pharmaceutical + Validation testing + Equipment validation + Computer system validation + Technical writing + Process validation + ... and high level technical personnel regarding cGMP compliance, regulatory issues, validation strategy, and quality systems for projects and/or strategic… more
- Integra LifeSciences (Plainsboro, NJ)
- …: * Equipment Qualification * Process Validation * Cleaning validation * Computer System Validation * Test Method Validation * Temperature ... outcomes and set new standards of care. Qualified candidates for this **Senior Validation Engineer** must be experienced in one or more of the following areas… more
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