- Cytiva (Muskegon, MI)
- …Qualification (OQ), Performance Qualification (PQ), process validation (PV), cleaning validation (CV) and Computer Software Validation (CSV) protocols ... possible.The Quality Assurance Engineer will be the subject matter expert for the validation strategy and maintain ownership of the Muskegon site Validation … more
- Aldevron (Miami, FL)
- …and 4+ years of experience with automation, engineering, networking, or Computer System Validation required.Experience with either Allen Bradley, Siemens, ... or Emerson PLCs required.Experience with HMI design, SCADA, DCS, and/or site scale control strongly preferredBiologics GMP manufacturing and processing requirementsRegulatory requirements for biologics manufacturingJoin our winning team today. Together, we'll… more
- Raytheon (Tucson, AZ)
- …accelerated technical growth.Qualifications You Must HaveEducation: BS in Computer Science, Electrical Engineering, Aerospace Engineering, Mechanical Engineering, ... CAS requirements, CAS architecture, requirements risk, requirements verification and validation , system performance & function, safety and environmental compliance.Experience… more
- Kedrion Biopharma (Melville, NY)
- …requirements, internal company standards and current industry practices. The focus of the Computer Validation Specialist role is to identify or create industry's ... clinicians in hematology, immunology, neurology, and transfusion medicine. **JOB SUMMARY** The Computer System Validation Specialist at Kedrion serves as SME… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …providing validation documentation and explanations and communicates company's computer validation policies. + Generating, reviewing, editing, and approving ... We are seeking a highly skilled, self-motivated **Senior Validation Specialist- CSV** to ensure compliance of computerized...role, you must have at least a** BS/BA in Computer Science, Engineering, Chemistry, or Life Sciences and 5+… 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 ... 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
- Bristol Myers Squibb (Indianapolis, IN)
- …aims to be the global leader in radiopharmaceuticals. The Sr. Manager, IT - GxP Computer Systems Validation & IT Process Lead is an integral part of bringing ... commercialization goals. **Job Responsibilities** + Manage and Deliver applicable risk-based Computer Systems Validation across RayzeBio Digital and IT teams.… more
- Abeona (Cleveland, OH)
- Job Description JOB TITLE: Computer System Validation Engineer Department: Validation Reports to: Director of Validation As a Computer System ... through commercial production. Essential Duties and Responsibilities . Develop and execute validation deliverables for new and existing GxP systems in alignment with… more
- Cognizant (Muskegon, MI)
- …work. The CSV Lead will have 10 plus years of experience of automation systems computer systems validation in a GMP environment. The CSV Lead will be responsible ... to assist Client in designing the validation strategy for the overall project and to coordinate...as other DCS and OT systems. **Requirements** : The Validation Lead responsibilities include: Project master validation … more
- Catalent Pharma Solutions (Somerset, NJ)
- **INTERNET POSTING** ** ** **Job Title:** Manager Computer System Validation and Data Integrity **City:** Somerset **State** : NJ **JOB DESCRIPTION** : ... business; Provide quality and regulatory oversight of the design, development, validation , implementation and ongoing maintenance and use of computerized GxP systems… more
- Fujifilm (College Station, TX)
- …of Computer cGMP regulations and practices pertaining to computer validation principles, manufacturing processes, quality systems, engineering design ... in Pharmaceutical or other regulated Industry. + Experience with qualification/ computer validation experience. + Experience with qualification/ validation… more
- Novo Nordisk (Bloomington, IN)
- …and approve deviations relevant to equipment validation + Understand other validation technical disciplines, such as cleaning, computer system validation ... + Understand other validation technical disciplines, such as equipment validation , computer system validation , and process validation , and be able… more
- Takeda Pharmaceuticals (Libertyville, IL)
- …focus on disciplines related to equipment, cleaning, process, control system and computer system validation . **How you will contribute:** + Experience applying ... Plans, Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification, Computer System Validation , and Validation … more
- Regeneron Pharmaceuticals (Troy, NY)
- We are hiring a Principal QA Validation Specialist to support validation and qualification of computer systems within IOPS. The Principal QA Validation ... Specialist would also plan, coordinate and participate in compliant computer system validation (CSV) process for systems which require formal validation … more
- Catalent Pharma Solutions (Harmans, MD)
- …Global cGMPs relevant to 21 CFR Part 11 compliance requirements and Global Computer System Validation , USP Guidelines, ICH Guidelines, and ISPE GAMP guidelines. ... **Associate Director, Validation & Engineering** Catalent Pharma Solutions is looking...Pharma Solutions is looking to hire a **Associate Director, Validation & Engineering** to lead our Equipment Validation… more
- United Therapeutics (Silver Spring, MD)
- … Datalogger Software (preferably Amphenol / Ellab) + Ability to perform validation activities for equipment, process and/or computer -related validation ... currently an option. **Who you are** Are you a validation professional looking to apply your expertise in a...a dynamic biotech and pharmaceutical environment? As a Lead Validation Engineer, Equipment, you'll be a subject matter expert… more
- Astellas Pharma (Sanford, NC)
- …coverage and flexibility may be required. **Preferred Qualifications** + Experience with computer verification/ validation . + Experience working in a clinical and ... **Specialist, QA Validation ** Do you want to be part of...visit our website: www.astellasgenetherapies.com. **The Role** The Specialist, QA Validation will be primarily responsible for the implementation, execution… more
- Kelly Services (West Point, PA)
- …communicate with the vendor/service engineer to identify resolutions. + Participate in computer system validation activities associated with new or upgraded ... **Job Title:** **Instrument Validation Specialist** **Responsibilities:** + Manage equipment assets at multiple locations. + Gain a working knowledge of laboratory… more
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