- 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 ... coordinating, working, and communicating with personnel across multiple departments. Performs validation activities related to the implementation of computer … more
- Catalent Pharma Solutions (Harmans, MD)
- **Senior Engineer, Computer Systems Validation ** **Position Summary:** Catalent, Inc. is a leading global contract development and manufacturing organization ... is hiring a Senior Engineer, CSV who is responsible for participating in validation projects related to manufacturing equipment, critical computer systems and… more
- PCI Pharma Services (Bedford, NH)
- …Collaborate with departments inside the organization to maintain and improve computer system validation processes to ensure robust, efficient, and ... electronic record and electronic signature assessments. + Generate and execute validation (IQ, OQ, and PQ) documentation for computer /computerized systems… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …providing validation documentation and explanations and communicates company's computer validation policies. + Generating, reviewing, editing, and approving ... You will be responsible for planning, executing, and documenting validation activities to meet FDA and potentially...role, you must have at least a** BS/BA in Computer Science, Engineering, Chemistry, or Life Sciences and 5+… more
- Lilly (Lebanon, IN)
- … computer systems. **How You'll Succeed:** + **Technical Leadership:** Provide computer system validation (CSV) technical leadership, ensuring compliance with ... : Provide CSV, mentoring, and training to peers on computer system validation topics, systems and processes,...years experience with strong understanding of regulatory requirements (eg, FDA , EMA) and industry standards (eg, GAMP, 21 CFR… more
- Boehringer Ingelheim (St. Joseph, MO)
- …of validation of biopharmaceutical processes, equipment, utilities, facilities, cleaning validation , and USDA and FDA /EU regulations. + * Excellence in ... comprehension/application of USDA and FDA /EU regulatory requirements for validation /qualification of equipment/process/cleaning...detail. + * This position requires ability to utilize computer programs such as Microsoft suite, SAP, IDEA for… more
- Novo Nordisk (Bloomington, IN)
- … department consists of four teams; Equipment/Facility, Process, Cleaning and Computer System Validation (CSV). The equipment/facility team initially qualifies ... and/or Engineers + Strong understanding of guidance documents from FDA , EMA, PDA, ISPE, ASME, ISO, and other industry...relevant to equipment validation + Understand other validation technical disciplines, such as cleaning, computer … more
- Novo Nordisk (Bloomington, IN)
- …and approve deviations relevant to validation + Understand all validation technical disciplines, including equipment, cleaning, computer system validation ... Join Team Novo Nordisk and help us make what matters. The Validation strategy is to manage projects relating to biopharmaceutical manufacturing equipment, critical… more
- Fujifilm (College Station, TX)
- …preferably in FDA -regulated environment. + Associate of Science Degree in Computer Science, Life Sciences, Engineering, or similar discipline with 7+ years of ... experience in pharmaceutical, biotechnology, or related industry, preferably in FDA -regulated environment, OR; + Bachelor's Degree and 5+ years...experience in computer system validation activities in pharmaceutical, biotechnology,… more
- Unither Pharmaceuticals (Rochester, NY)
- Validation Technician Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify ... Your role Reporting to the Quality Director, JOB SUMMARY: Assists validation efforts in many ways including the following: executes/supports equipment, cleaning,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders. **Summary** The Validation Lead will manage Global DX Computer System Validation ... regulatory expectations and business needs. + Oversee and/or execute the regulatory-compliant computer system validation or qualification of global GxP and… more
- Abbott (Casa Grande, AZ)
- …(GDP), and current Good Manufacturing Practices (cGMP). Familiarity with GAMP5 and FDA 's Computer Software Assurance initiatives are preferred. + Proficient with ... generic medicines. Our 114,000 colleagues serve people in more than 160 countries. ** Validation Engineer - Casa Grande, AZ Nutrition Plant** **Working at Abbott** At… more
- Bio-Techne (St. Paul, MN)
- …Bring your talent to our Bio-Techne! We are seeking an Advanced Quality Validation Engineer with experience in GMP qualification and validation . This position ... a dynamic team with diverse experiences/backgrounds. You will support with qualification / validation activities leading to new product launches. Quality is one thing… more
- Bristol Myers Squibb (Warren, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Title:** Validation Engineer (CSV) **Location:** Warren, NJ The ** Validation Engineer ... compliance with policies, guidelines, and procedures. Through this work, the validation engineer supports the successful operation of facility, laboratory and… more
- Curia (Albuquerque, NM)
- …and manufacturing process protocols and final report. + Review and approve validation protocols for computer related systems (as needed), environmental ... mapping and use of Kaye Validator + Experience with FDA and EU regulations for pharmaceuticals and validation...form and deal with several abstract and concrete variables. Computer Skills: The ideal candidate will possess a strong… more
- Integra LifeSciences (Plainsboro, NJ)
- …or more of the following areas of validation : * Equipment Qualification * Process Validation * Cleaning validation * Computer System Validation * ... a production setting. **Responsibilities** + Generation and execution of qualification/ validation protocols including the generation, routing and approval of summary… more
- United Therapeutics (Silver Spring, MD)
- … Datalogger Software (preferably Amphenol / Ellab) + Ability to perform validation activities for equipment, process and/or computer -related validation ... arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with...currently an option. **Who you are** Are you a validation professional looking to apply your expertise in a… more
- BD (Becton, Dickinson and Company) (El Paso, TX)
- **Job Description Summary** The Quality Software Validation Engineer will develop and execute validations to ensure regulatory compliance to established internal and ... released product or current production. The individual will support the writing of validation protocols and reports, along with the gathering and analysis of data.… more
- Endo International (Rochester, MI)
- …Summary** The co-op student will be responsible for assisting the Engineering and Validation department in various projects related to Computer Systems and ... student will be responsible for assisting the Engineering and Validation department in various projects related to Computer...+ Proficiency in AutoCAD. + Familiarity with cGMP and FDA regulations is preferred. + Availability to work full-time… more
- L'Oreal USA (Somerset, NJ)
- …Search (https://careers.loreal.com/en\_US/jobs/SearchJobs) / 198543 Mgr. Mfg. Safety Validation Somerset, NJ, New Jersey Apply now ... & Facilities Full - Time 10-Feb-2025 Job Title: Manager - Safety Validation Division: L'Oreal Dermatological Beauty Location: Somerset, NJ Reports To: Sr. Manager… more