Validation Engineer
3 weeks ago
Not for C2C Candidates Please
Role: All Validation Engineer (V&V, CQV, CSV, Equipment, Process)
Location: Country Wide USA
Duration: 12+ months + extensions
Visa{ USC, GC, H4 OPT CPT
Job Description:
Process and equipment qualification (IQ/OQ/PQ).
Development of test methods for Design V&V, Process Validation, and Production
Validation of test methods
Execution of Engineering Builds, Gauge R&R Studies, Attribute Analysis Studies, and other validation work
Authoring/releasing of new test methods and editing/redlining of old test methods
The education/experience I am looking for is as follows:
This position requires a Bachelor of Science in Engineering or combination of relevant education and experience as well as 5 years relevant experience in medical device manufacturing.
Expertise in medical device manufacturing and with strong working knowledge of cGMPs.
Clean room environment experience
Manufacturing Engineering and automation experience.
Experience with Test Method Validation and/or Measurement System Analysis is preferred.
Knowledge of computer software for the analysis of data, specifically Microsoft Excel and statistical packages (Minitab preferred), is a plus.
Demonstrated understanding of FDA Quality System Regulation (21 CFR 820) and ISO 13485.
Strong organizational skills, detail oriented.
Ability to collaborate within an organization across all functional departments (e.g. Legal, Regulatory, Operations, Procurement, Clinical Affairs, Operations, Marketing, Quality, etc.)
Ability to work to a deadline and to handle multiple tasks simultaneously.
Experience with Microsoft Office including Microsoft Word, Excel, PowerPoint, and Project.
-
Validation Engineer
4 days ago
New York, United States Astrix Inc Full timeOur client is a global, research-driven pharmaceutical focusing on treatment options for diseases and conditions for which there is no satisfactory treatment option to date. The company is looking for a Validation Engineer to join the team. This is an amazing opportunity to work on cutting edge treatments and make a difference! Shift : M-F 1st shift Type : 7...
-
Validation Engineer
2 weeks ago
New York, United States Kelly Science, Engineering, Technology & Telecom Full timeValidation Engineer | Contract-To-Hire Clearwater, FL | On-Site The Validation Engineer is responsible for developing, documenting, and validating manufacturing processes, related to the manufacture, inspection, and packaging of lathed intraocular lenses. Specific tasks to include: new technology and process improvements for existing manufacturing processes,...
-
Validation Engineer
4 days ago
New York, United States PCI Pharma Services Full timeSummary of Objective: The Validation Engineer is responsible for the qualification/validation of pharmaceutical equipment, processes, and test methods for the assembly, inspection, testing, and packaging of medical devices. Core functions include management of validation projects, generation and execution of validation protocols, evaluation of statistical...
-
Senior Validation Engineer
4 weeks ago
New York, United States TalentBurst Full timeTitle: Validation Engineer III, Req#: ROCGJP00025890 Location: Oceanside, CA (100% onsite) Duration: 8+ months Contract Job Description: A Validation Engineer plans, implements, and monitors the validation strategy in highly regulated industries such as pharmaceutical or medical device manufacturing. Education and Experience: 5 -7 years of relevant...
-
Clean Validation Engineer
2 weeks ago
New York, United States Trinity Consultants Full timeADVENT's services include process engineering, automation engineering, project engineering, HVAC/facility system design, process development, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies. The successful candidate will work with a group of engineers...
-
Senior Validation Engineer
2 weeks ago
New York, United States SciPro Inc. Full timeSenior Validation Engineer (Contract) Location: Van Nuys Area Role Overview We're seeking a highly skilled Senior Validation Engineer for a temporary onsite role. Reporting to the Manager of Quality Engineering, you'll support our quality engineering team with documentation and validation tasks for automation projects. You'll also draft design...
-
Senior Validation Engineer
3 weeks ago
New York, United States Bolt Medical Full timeDIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES. RECRUITERS: DO NOT CONTACT. SUMMARY OF THE JOB As a Senior Validation Engineer, you will play a critical role in ensuring the quality and compliance of products by developing and implementing robust validation strategies. Your expertise will be essential in verifying and...
-
Validation Engineer
2 weeks ago
New York, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities: Review qualification requirements for any new instrument, equipment and process with system owner and cross-functional teams. Prepare protocols and reports related to equipment/system/utility qualification (IQ/OQ/PQ), calibrations, engineering, process, packaging, and cleaning validations. Preparation and review of associated procedures,...
-
Validation Engineer
1 week ago
New York, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities: Review qualification requirements for any new instrument, equipment and process with system owner and cross-functional teams. Prepare protocols and reports related to equipment/system/utility qualification (IQ/OQ/PQ), calibrations, engineering, process, packaging, and cleaning validations. Preparation and review of associated procedures,...
-
Senior Validation Engineer
3 weeks ago
New York, United States BioPhase Full time*US Citizens or Greencard Holders only* **No C2C** Work Schedule: Onsite - M-F Salary: $60-70/hr Duration: 4 months Primary Responsibilities: Support the Quality Engineering group with documentation and validation needs. Draft URS documents, design specifications, testing protocols, and final reports. Perform hands on validation execution for automation...
-
Validation Engineer
1 week ago
New York, United States Premier Life Sciences LLC Full timeNot For C2C Candidates Please do not apply even not enquire Job Title: CQV Validation Engineer Location: Countrywide USAContract Duration: 12+ monthsPay: Negotiable on w2 without any benefitsResponsibilities:Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and...
-
Senior Validation Engineer
4 days ago
New York, United States BioPhase Full time*US Citizens or Greencard Holders only* **No C2C** Work Schedule: Onsite - M-F Salary: $60-70/hr Duration: 4 months Primary Responsibilities: Support the Quality Engineering group with documentation and validation needs. Draft URS documents, design specifications, testing protocols, and final reports. Perform hands on validation execution for automation...
-
Validation Engineer
3 weeks ago
New York, United States Ascendum KPS Full timeJob description Improving manufacturing processes using engineering methods (e.g., LEAN methods, basic statistics) for continuous process improvement. Developing basic experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyzing results, making recommendations, and developing reports. Analyzing...
-
Senior Validation Engineer
3 weeks ago
New York, United States Rbw Consulting Full timeSenior Validation Engineer Are you a validation expert looking for a new, dynamic environment? I am partnering with a rapidly growing full service CDMO who are specialised within sterile product development, manufacturing and packaging, and am working with the leadership team to help appoint a number of new hires. For this specific hire, we are seeking and...
-
Quality Validation Engineering Consultant
3 days ago
New York, United States cyberThink Full timeJob Description: This position of Validation Specialist is to support manufacturing toward industrial excellence to guarantee the accuracy, conformity and competitiveness of the processes and techniques utilized for the production of the vaccines and biologics manufactured at the industrial sites. The mission is to deliver robust and efficient process &...
-
System Validation Engineer
3 weeks ago
New York, United States Amtex Systems Full timeModem System Validation Engineer Bridgewater, NJ - Onsite Position 12 Months Looking for Modem, 5G Protocol and log Analysis experience. Find the JD below for your quick reference. Conduct research and analysis to define features and functions for 5G advanced and 6G. A firm/expert working knowledge of 5G/LTE and VoLTE Platforms. Deep 4g/5g protocol...
-
Validation Engineer
1 month ago
New York, New York, United States LS Solutions Inc. Full timeKey Responsibilities Strong Experience in Computer Systems Validation (CSV) within the pharmaceutical industry. Required Bachelor's degree in pharmaceutical Science OR related field of study. Schedule and plan equipment and process qualification workload to meet approved schedules. Handle multiple projects and be able to work independently as required....
-
Senior Equipment Validation Engineer
1 week ago
New York, United States Rbw Consulting Full timeRBW Consulting are excited to present an opportunity for a Senior Validation Engineer with a CDMO partner of ours! With over 20 years experience in the industry, they are passionate about supporting companies from Development to Commercial launch of their Sterile products, with a particular focus on Injectables. Dedicated to quality and growth, our partner...
-
Network Test and Validation Engineer
2 weeks ago
New York, United States Mastech Digital Full timeTitle: Network Test and Validation Engineer Location: Fremont, CA Duration: 6+ months contract Network Test and Validation: Perform network audits to evaluate : Capacity usage (BW, space, power, etc.), Unused devices Analyze for network reports and review network trends and suggest improvements Deploy agents to monitor networks by using Prod tools and...
-
Validation Manager
1 week ago
New York, United States Anika Corporation Full timeSummary of Primary Responsibilities: This position is responsible for managing the Bedford Site’s Validation program that includes start-up, commissioning, qualification, validation and revalidation projects for facility, equipment, critical utility, automation/computer system, cleaning, sterilization, and medical device/drug product manufacturing...