Pharma CSV Validation Specialist
Creative Solutions Services, LLC
Creative Solutions Services, LLC is seeking a qualified candidate for a role focusing on validation in the pharmaceutical industry. Candidates should have over 3 years of experience in Computer System Validation and a strong background in FDA regulations. The position requires strong communication skills, the ability to work as part of a team, and experience leading projects effectively. Familiarity with QA methodologies and the System Development Lifecycle is essential. #J-18808-Ljbffr Creative Solutions Services, LLC
- Katalyst CRO is looking for a CSV Consultant in Raritan, NJ to support system validation activities in a regulated environment. The consultant will ensure compliance with FDA guidelines, contribute to validation documentation, and work within the System Development Lifecycle...Suggested
- ...Job Description We are seeking a Senior Validation Engineer with solid hands-on validation experience... ...activities Knowledge of CSV methodology and required lifecycle document... ...Cellares enables academics, biotechs, and pharma companies to accelerate drug development...SuggestedContract workFor contractorsFlexible hours
- ...innovative and highly motivated Senior Quality Validation Specialist, who will contribute significantly to... ...limited to facility plans, validation, CSV and other technical protocols and... ...Cellares enables academics, biotechs, and pharma companies to accelerate drug...SuggestedFlexible hours
$120k
...to advance the promise of an immunotherapy in the treatment of multiple myeloma. Company Legend Biotech USA, Inc Job Title Validation Specialist Job Duties Execute site validation activities to the current regulatory and site requirements and address deviations associated...SuggestedPermanent employmentFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hours- ...candidate for a role focused on Technology Quality Manufacturing and MES Services. This position requires a strong CSV and Quality expertise for leading validation activities across the SDLC in GxP systems with a desire for 7-10 years of relevant experience. Key...SuggestedRemote work
- Piper Companies is seeking an experienced CQV Validation Engineer in Raritan, NJ, to assist with the IQ/OQ/PQ of new instruments/equipment. This role involves developing validation protocols, conducting testing, and providing technical support to ensure compliance with...
- A leading technology consulting firm is looking for an Experienced Validation Lead to support the end-to-end validation of a Unified Regulatory Platform built on Veeva and AWS cloud technology. The ideal candidate will have over 8 years of experience in Computer System...
- Initial Therapeutics, Inc. is looking for a Validation Specialist to execute site validation activities and ensure compliance with regulations. You will oversee equipment qualifications, manage manufacturing controls, and support process validation in a dynamic biopharma...
- ...obsessed with how it will be done. Key Responsibilities CQV Execution & Safety - Perform Commissioning, Qualification, and Validation (CQV) activities with a strong focus on safety - Deliver C&Q activities in alignment with project schedules - Track and...For contractorsWorldwide
- Job Description Job Description Are You Ready? CAI is a professional services company established in 1996 that has grown to nearly 800 people worldwide. For mission-critical and regulated industries needing to deliver essential solutions in high-stakes environments...Worldwide
- Piper Companies is currently looking for an experienced CQV Validation Engineer in Raritan, NJ to work for an innovative and growing pharmaceutical organization. The primary responsibility of this role is to assist with the IQ/OQ/PQ of new instruments/equipment in support...
$93.46k - $122.67k
Job Overview QA Validation Specialist III role at BioSpace, based in Raritan, NJ. Exempt level position responsible for quality oversight of validation and qualification activities for equipment, systems, computer systems, and processes within a cell therapy manufacturing...Work at officeFlexible hours- ...established industry player is seeking an IT Quality Compliance Specialist/Analyst to ensure regulatory compliance across the product... ...involves managing the GxP IT Quality Assurance program, reviewing validation deliverables, and supporting inspections. Ideal candidates...
- ...A leading technology organization in Raritan, New Jersey, seeks a skilled professional to document software and validate specifications for lab instrumentation. Key tasks include gathering requirements, creating infrastructure and data flow diagrams, and performing risk...
- Experienced Validation lead to support end to end validation ownership of a Unified Regulatory Platform (URP) built on Veeva and AWS based... ...Provide general guidance and support regarding SDLC and CSV processes, ensuring best practices are followed Providing audit...
- IT Quality Compliance Specialist/Analyst Hybrid role--Local Candidates Only Work Schedule: Mon - Fri, Business Hours Must have's: Ideal... ...Bonitasoft BPM) Quality assurance mindset for computer system validation for GMP, GDP, GLP space. Regulatory expertise to read and interpret...Local area
- ...designers/engineers and other project team members to plan, and complete tasks associated with commissioning, qualification and validation of new and modified equipment, facilities, utilities, product, processes etc.in line with project, operations and quality objectives...Contract workTemporary workLocal areaMonday to FridayNight shiftWeekend work
- ...This has helped us expand into new sectors and steadily grow. Job Description Responsibilities: Investigates and troubleshoots validation problems for equipment and/or performance processes and conducts equipment qualification activities. Conducts analyses of testing...
$80k - $90k
Description Process Engineer reports to the Manager of Technical Services and plans, executes and functionally directs Process/Cleaning Validation/Study assignments and projects, which require sound pharmaceutical/engineering skills and independent judgment. Works as a team...Flexible hours$80k - $90k
...seeking a Process Engineer to report to the Manager of Technical Services. The ideal candidate will execute and manage cleaning validation and post-approval projects, working collaboratively with various departments. The role requires a Bachelor's degree in Pharmaceutical...- ...preparing documentation for all aspects of the computer system validation life cycle. Design, deliver, support and maintain GxP computerized... ...is acceptable. Required Skills CAPA CGXP GAMP HP ALM CSV 21 CFR Audit Trial Agile GAP Analysis Service Now Work Location...
- A leading technology solutions provider in New Jersey is seeking a Testing Specialist with experience in the Lifesciences industry. The role involves managing testing processes, ensuring adherence to Agile methodologies, and collaborating with various stakeholders. Ideal...
- ...Job Description Job Description Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory...
- ...biotechnology manufacturing expansion project in Raritan, NJ. The role will involve supporting commissioning, qualification, and validation for aseptic processing isolators and GMP manufacturing equipment. The ideal candidate should have a Bachelor’s degree in Engineering...
$91.7k - $135k
JOB DESCRIPTION Work Schedule Standard (Mon-Fri) Environmental Conditions Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Job Description The Engineer...Remote jobFull timeTemporary workWork at office- ...who thrives in a fast-paced environment and is passionate about learning and problem-solving. This role is responsible for the validation of production powertrain control modules, including hardware, software, and calibrations—primarily in the battery electric vehicle...Full timeImmediate start
$90k - $100k
Merck & Co. in Piscataway Township is looking for an Automation Engineer to oversee automation systems aimed at enhancing production efficiency and reducing costs. The ideal candidate will design and implement advanced hardware and software solutions within pharmaceutical...- ...development at other sites or directly from customers Lead Master Validation Plan creation in order to support PPQ campaigns Lead and... ..., preferably within cell and gene therapy Experience in the Pharma/Biotech industry in technology transfer Must know and follow...Flexible hours
- ...are seeking an Automation Engineer to support the development, validation, and day-to-day operation of fully automated QC testing workflows... .... Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing...Flexible hours
$40 - $50 per hour
...communicating what is happening on the production floor. The ideal candidate has GMP manufacturing, process support, MSAT, biotech/pharma production, or equipment support experience, plus enough hands-on mechanical ability to troubleshoot basic equipment issues....Full timeMonday to Friday
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