- Merck & Co. (Rahway, NJ)
- …and mitigationManaging/ implementing commissioning, qualification, contract administration and project close-out.The Senior Specialist , Engineering will strive ... Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation .-Our Global Engineering Solutions executes a wide variety of capital… more
- Merck & Co. (Durham, NC)
- Job DescriptionWe are seeking a Growth and Improvement minded Specialist , Sterility Assurance that can help drive our Strategic Operating Priorities.Invent - Pursue ... and Standards will Continue to Guide Us as We Take on New ChallengesThe Specialist , Sterility Assurance will serve as a member of the Sterility Assurance team… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking CQV Specialist (Contractor) as part of the Technical Operations team based in Raritan, ... OverviewThis position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy… more
- Merck & Co. (Durham, NC)
- Job DescriptionSenior Specialist , Quality Systems and ComplianceOur company is expanding its global recombinant vaccine production network by investing and adding a ... comprised of fermentation, microfiltration/ultrafiltration, and chromatography steps.The Quality Senior Specialist provides expertise in the coordination of resources and… more
- Aequor (Swiftwater, MN)
- …of validation and development studies. The position will support the Validation Specialist /execution by obtaining and compiling data into a data pack ... coordinator is a critical role in the execution of validation and development studies. Failure to comply with the...The number of documents managed will vary according to project load and can range from 700 to 1,200… more
- Merck & Co. (Durham, NC)
- …product inspection, and quality control laboratories. - The Quality Assurance Specialist will support this expansion. Project activities requiring support ... Job DescriptionPosition Description: Specialist , Quality Assurance 1st Shift - Our Company...Reporting to the Quality Assurance Organization, will independently manage project assignments. Ensure individually assigned aspects of the … more
- Merck & Co. (Durham, NC)
- …product inspection, and quality control laboratories.The Senior Quality Assurance Specialist will support this expansion. Project activities requiring ... Job DescriptionPosition Description: Senior Specialist , Quality Assurance Our Company will construct a...Reporting to the Quality Assurance Organization, will independently manage project assignments. Ensure individually assigned aspects of the … more
- Kelly Services (Anasco, PR)
- … Validation Protocols, Drawings, Routers, etc identified as required as part of the project needs. * Validation Executions - Participate in the validation ... ensure compliance with ISO 11607 as part of the project deliverables. The incumbent will be working with cross...test, among others). * Must have knowledge in shelf-life validation (aging studies), sterile barrier sealing process validation… more
- Kelly Services (Anasco, PR)
- …above. Responsible for the delivery of tasks to ensure conformance to the project plan schedule. **Education and/or experience:** * BS in Science or Engineering, ... with EU MDR or MDD remediation projects, compliance projects and process validation required. * Experience with managing documents within electronic PLM system. *… more
- Boehringer Ingelheim (St. Joseph, MO)
- …specifications and requirements and are suitable for their intended purposes. The Principal Specialist , Validation will lead project management efforts for ... manages all phases of higher level, more complex validation project activities at the BIAH location...software (MS-Word, MS-Excel, MS-Outlook, PowerPoint). **Requirements for a Sr. Specialist Validation ** + A BS degree from… 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 ... are being maintained in a validated state. Generates applicable validation project plans and risk assessments. Responsibilities...If completed by an external company, the computer systems validation (CSV) specialist will be responsible for… more
- Boehringer Ingelheim (Athens, GA)
- …specifications and requirements and are suitable for their intended purposes. The Principal Specialist , Validation will lead project management efforts for ... Boehringer Ingelheim's high regard for our employees. The Principal Specialist , Validation manages all phases of higher... manages all phases of higher level, more complex validation project activities at the BIAH location… more
- Kedrion Biopharma (Melville, NY)
- …hematology, immunology, neurology, and transfusion medicine. **JOB SUMMARY** The Associate Validation Specialist at Kedrion provides technical input to Kedrion's ... aseptic process introduction into clinical and commercial facilities, the Associate Validation Specialist must integrate and successfully utilize knowledge and… more
- BioFire Diagnostics, LLC. (Lombard, IL)
- The Validation Specialist will develop, implement, and manage validation activities across multiple domains, including equipment, process, software, ... and internal procedures, minimizing risks while supporting operational excellence. The Validation Specialist will work closely with cross-functional teams,… more
- GE HealthCare (IL)
- **Job Description Summary** The Clinical Validation Specialist will play a crucial role in executing product development assessments and pre-clinical ... Identify, document, and report defects according to established procedures. + ** Project Oversight:** Oversee validation tasks and resources to ensure… more
- United Therapeutics (Silver Spring, MD)
- …an engineering degree will still be considered; however, the job title will be as a Validation Specialist ) + 8+ years of relevant validation experience in a ... currently an option. **Who you are** Are you a validation professional looking to apply your expertise in a...work practices, procedures, and guidance + Ability to anticipate project needs, potential gaps, and pitfalls through forecasting and… more
- University of Washington (Seattle, WA)
- …Medicine and Pathology** has an outstanding opportunity for a **Computer Systems GxP Validation Specialist ** **WORK SCHEDULE** + Temporary appointment + 100% FTE ... + Experience requirement, minimum: 4 years of direct experience in validation in a clinical contract research organization, pharmaceutical, biotechnology, or… more
- Danaher Corporation (Anaheim, CA)
- …System which makes everything possible. As a key contributor within Cytiva, the Sales Specialist , Validation Services USCAN West & LATAM plays a pivotal role in ... driving our Validation Services solutions' growth and strategic positioning within the...years of commercial experience (eg, sales, account management, or project management) in the Pharmaceutical, Biotech, or CDMO field… more
- ATS Automation (Warminster, PA)
- …Requisition ID: 13624 Location: Warminster, PA, US, 18974 Date: Feb 10, 2025 Validation & Documentation Specialist ATS Scientific Products is seeking a full‐time ... Validation and Documentation Specialist in Warminster, PA to create and maintain various...edit content, working closely with various departments to understand project requirements. + Gather information from subject‐matter experts and… more
- WuXi AppTec (Philadelphia, PA)
- …impact assessments, risk assessments, requirements traceability, URS, FDS, procedural mappings and Validation Project Plans. + Stay current with changes to GXP, ... for the development, execution, review, and approval of Computerized Systems Validation , System Life Cycle Documentation ( Validation Plans, Design… more
