- Insmed Incorporated (San Diego, CA)
- …Preferred Skills, Experience and Education): 7+ years' hands-on experience in a validation role with responsibility for computer systems specifically LIMS, ... strategic leadership and decision making on CSV strategy Develop risk-based validation strategies for system implementation and changes following CSV SOPs and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …level position with responsibilities for providing quality oversight over the validation and qualification activities for equipment, systems, computer systems, ... assessments, technical studies, and any associated documentation in support of computer systems validation , equipment, utilities, and facility qualification,… more
- ValSource, Inc. (Rahway, NJ)
- …cleaning validation is desirable. Working knowledge of process automation and computer system validation concepts, GAMP methodologies, 21 CFR Part 11 ... our regions in the US. The Commissioning, Qualification & Validation (CQV) Project Manager will interface with our clients...which includes vessel spray coverage testing. Working on a computer to draft protocols, analyze data and write reports.… more
- Endo International (St. Louis, MO)
- …and review. The position will also have responsibilities for the review/approval of validation activities for enterprise computer system software and other ... leads. + Interaction with colleagues at other sites involved with enterprise computer system software, Data Integrity, and equipment/process validation needs. +… more
- Curia (Albuquerque, NM)
- …and manufacturing process protocols and final report. + Review and approve validation protocols for computer related systems (as needed), environmental ... Senior Principal Validation Engineer in Albuquerque, NM Build your future...form and deal with several abstract and concrete variables. Computer Skills: The ideal candidate will possess a strong… more
- Curia (Albany, NY)
- …and team members to keep apprised of computerized system needs, impacts on computer validation , project validation status, and other relevant issues ... CSV Systems Engineer will be responsible for supporting Quality Management Systems and Computer System Validation efforts. This role will provide guidance and… more
- Caris Life Sciences (Irving, TX)
- …Supports the authoring and reviewing of pre-defined deliverables as identified in the Computer System Validation Process and applicable Software Validation ... lead auditor to ensure the supplier's software development and validation practices comply with Caris's Computer System...development and validation practices comply with Caris's Computer System Validation Process. + Leads process… more
- Insmed Incorporated (NJ)
- …an experienced leader to oversee cybersecurity operations, enterprise risk management, and Computer Systems Validation (CSV) program. This role will manage ... and protect sensitive patient and research data.Demonstrated experience leading a Computer Systems Validation team in a regulated (pharmaceutical, biotech,… more
- Formation Bio (New York, NY)
- …that ensure Formation Bio and its vendor network comply with GXP, and Computer validation standards. Provide leadership and direction to the quality assurance ... (GLP), Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GPV) and Computer Systems Validation (CSV).The primary responsibilities for the Vice… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …strongly preferred.Experience with Manufacturing Execution Systems (MES) design/development and validation is preferred.Experience with Computer System ... manufacturing and protocol-driven activities such as tech transfer and process validation .Assist in the development of process, operational, and quality improvements… more
- Parexel (Columbus, OH)
- …acquisition and installation, performance or coordination of routine maintenance, computer system validation , and regulated systems retirement **Qualifications ... with troubleshooting and/or perform maintenance or calibration activities + Participate in computer system validation activities associated with new or upgraded… more
- Cipla (Fall River, MA)
- …of qualification and validation documents. Preparation of qualification and validation documents of equipment and computer system. Preparation and ... Job Title : Mfg. Validation Engineer FLSA Classification : Professional, Exempt Work...with experience in generic pharmaceutical manufacturing. Technical Knowledge and Computer Systems Skills Excellent communication skills, drive, and sense… more
- Syner-G BioPharma Group (Boston, MA)
- …information, visit www.Synergbiopharma.com (Syner-G is seeking both Process and Validation Engineering Candidates) PROCESS ENGINEER POSITION OVERVIEW : Syner-G is ... specifications, design & development of process parameters, and the commissioning/ validation of manufacturing processes for compliance with quality and regulatory… more
- Cipla (Hauppauge, NY)
- …working outside of Cipla's US Subsidiaries or Affiliates. Job Title : QA Validation FLSA Classification : Professional, Exempt Work Location : Unit 1, Hauppauge, NY ... vary based on business needs) Reports To : QA Validation Manager Salary Range: $68,000 - $74,600 Purpose: The...pharmacy) or a related field. Must be proficient in computer skills and software applications such as Microsoft Office… more
- Usaa (Colorado Springs, CO)
- …We are seeking a skilled individual to execute comprehensive model risk validation oversight for the lifecycle management of models. This includes conducting ... thorough model validation activities and ensuring adherence to written risk and...as Economics, Mathematics, Statistics, Actuarial Science, Data Science, Engineering, Computer Science, or a Related Field with Core Quantitative… more
- International (Elmendorf, TX)
- …and solutions to our customers. We currently have a great opportunity for a Validation Project Engineer on our TRATON USA's R&D Team. This is an exciting opportunity ... to be hands-on with physical testing, validation , and development of commercial vehicle components-including cabs, doors, interiors, exteriors, hoods, steering… more
- International (Elmendorf, TX)
- Position Overview We are seeking an experienced Senior Engineer - HVAC, Testing and Validation to join the TRATON R&D US Team! With its brands Scania, MAN, ... our customers. The Senior Engineer - HVAC, Testing and Validation will lead and execute testing activities focused on...Requirements + Bachelor's degree in Engineering, Engineering Technology or Computer Science + At least 2 years of experience… more
- Micron Technology, Inc. (Boise, ID)
- …world uses information to enrich life for all. **Position Overview** As a Validation Engineering Intern, you will work closely with Micron's Module Development Teams ... and reports. + Develop tools in Jira to organize and compare validation results across component generations. **Minimum Qualifications** + Currently pursuing a… more
- Insmed Incorporated (NJ)
- …the GxP IT CAB process) Who You Are:5+ years' experience in a management validation role with responsibility for computer systems specifically eTMF, CTMS, EDC, ... periodic reviews, and audit trail reviews.What You'll Do: Develop risk-based validation strategies for system implementation and changes following CSV SOPs and… more
- Bank OZK (Little Rock, AR)
- …oversight for all aspects of model risk including model governance, model validation , and ongoing model monitoring. Provides technical leadership for a team of ... + Provides technical leadership to a team of model validation professionals to assess, validate, and review all aspects...with both customers and employees. + Skill in using computer and Microsoft Office, including Word, Excel, Outlook and… more
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