- Aequor (Athens, GA)
- …Normal 9 am - 5 pm, no shift work Duties: Write analytical method validation protocol in compliance with all applicable FDA/EU/USDA regulations as well as corporate ... procedures Provide oversight of validation project and coordinate with laboratory experimental test execution...the area manager(s) for project management, project timelines, regulatory documentation and final reports for submission to the USDA… more
- Aequor (Davie, FL)
- …Review and analysis of the analytical and statistical data to support the pre- validation work. Analysis of data to ascertain the data meets protocol and product ... criteria: writes deviation reports and technical assessments as required. Supports pre- validation commercial scale report that includes detailed summary of the… more
- Merck & Co. (Durham, NC)
- … Validation , and New Product Technical Transfer Departments.The Associate Specialist - Process Engineer will support one of these Technical Departments. ... Projects, Maintenance, Safety, Process Development, Technical Services, Utilities, and Validation . Position Description: Durham-Technology consists of the Automation/MES, Deviation… more
- vaco (Lexington, KY)
- … validation project. We are seeking a detail-oriented and highly organized Data Validation Specialist to assist with a critical data scrub and validation ... information with discretion.Follow detailed procedures and contribute to process documentation as needed.Qualifications:Strong proficiency in Microsoft Excel (required).Experience working… more
- Merck & Co. (Durham, NC)
- …Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation . Position Description: The Senior Specialist , is a ... processesProviding direct support for regulatory inspections and audits and other validation activities by serving as the subject matter expertUnderstands and… more
- ATS Automation (Warminster, PA)
- …Industries Requisition ID: 15756 Location: Warminster, PA, US, 18974 Date: Oct 3, 2025 Validation and Documentation Specialist SP Industries Inc.is seeking a ... documentation or equivalent years of relevant experience. (Technical writing/ validation experience for pharmaceutical or biotechnology products preferred.) + One… more
- Insight Global (Hopewell Township, NJ)
- Job Description Our top Pharmaceutical client is seeking a Documentation and Validation specialist to join their External Call Center team within their ... a resource with IVR and Contact Center knowledge to spearhead documentation and validation of processes. The ideal resource will have experience with Salesforce… more
- Unither Pharmaceuticals (Rochester, NY)
- Computer Systems Validation Specialist Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that ... Design Specifications. If completed by an external company, the computer systems validation (CSV) specialist will be responsible for obtaining these documents… more
- Catalent Pharma Solutions (Kansas City, MO)
- **Senior Validation Specialist I, BioAnalytics Computer System Validation (CSV) & Compliance** **Position Summary:** Catalent, Inc. is a leading global ... in Kansas City, MO (KCM) is hiring a Senior Validation Specialist I, BioAnalytics CSV & Compliance....audits. Follow cGMP requirements for legible, accurate and thorough documentation to meet regulatory compliance. Mentor junior colleagues in… more
- West Pharmaceutical Services (Exton, PA)
- …D&T and the laboratory for the preparation or providing input for computer system validation documentation such as FMEA, computer system profile, URS, 21 CFR gap ... Senior Specialist , Computer System Validation Requisition ID:...documentation for equipment that requires a computer system validation approach. You will collaborate with internal stakeholders (Quality… more
- Reckitt (Wilson, NC)
- Validation Specialist City: Wilson **We are Reckitt** Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why ... in our great organisation. **About the role** The QA Validation Specialist is responsible for executing and...transfers per site master plan. + Maintain SDLC and validation documentation (URS, risk assessments, traceability, reports)… more
- Curia (Rensselaer, NY)
- Senior QA Validation Specialist - CSV Systems Engineer Summary: The Senior Validation Specialist , assists with the validation activities throughout ... staff meetings, as well as applicable project teams + Track all validation documentation throughout the plant and follow-up as needed + Exhibit safety awareness… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- We are seeking a highly skilled, self-motivated **Senior Validation Specialist - CSV** to ensure compliance of computerized systems with regulatory requirements ... 11, GAMP 5, and Annex 11. **As a Senior Validation Specialist , a typical day might include:**...and other applicable acceptance criteria + Creating and maintaining validation documentation , including Validation Plans,… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …Fill Finish QA Validation team is hiring. As the Senior QA Validation Specialist , you will ensure equipment, systems, and processes meet regulatory standards ... edits and approves change controls, SOPs, reports and other documentation + Coordinates with other departments or outside contractors/vendors...the following years experience for each level: + QA Validation Specialist : 2+ years + Sr QA… more
- System One (Athens, GA)
- Job Title: Analytical Method Validation Specialist Location: Athens, GA Hours/Schedule: 9am- 5pm Type: Contract Overview Global pharma company looking to bring ... on an entry to mid level Analytical Method Validation Specialist to their growing team. Must...the area manager(s) for project management, project timelines, regulatory documentation and final reports for submission to the USDA… more
- Boehringer Ingelheim (Athens, GA)
- …programs reflect Boehringer Ingelheim's high regard for our employees. The Principal Specialist , Validation manages all phases of higher level, more complex ... and requirements and are suitable for their intended purposes. The Principal Specialist , Validation will lead project management efforts for validation… more
- SMBC (White Plains, NY)
- …continuous improvement of the model quality and governance. The Sr Model Validation Specialist applies numerical, statistical and qualitative knowledge to ... assessment, model changes, and ongoing monitoring results Develops and maintains documentation , work papers and professional reports of validation results.… more
- Astellas Pharma (Sanford, NC)
- ** Specialist , QA Validation (Onsite in Sanford, NC)** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every ... . **The Role** This is an **Onsite** role in **Sanford, NC** . The ** Specialist , QA Validation ** is responsible for providing quality assurance oversight and… more
- AbbVie (North Chicago, IL)
- …YouTube and LinkedIn. Job Description Purpose: The primary responsibility for the Quality Validation Specialist is the Quality oversight and overall approval of ... validation and engineering change management activities. The ...documentation is in accordance with cGMP and supports validation *May supervise contract validation resources in… more
- Bausch + Lomb (Tampa, FL)
- …and write final reports to summarize testing performed. Gather all pertinent documentation required for completing the validation activity. + Communicate the ... of the Job:** This position will perform and/or support the qualification/ validation of the following validation elements: manufacturing/ packaging equipment,… more
