Validation Lead
Resource Logistics
- Validation Lead(Computer System Validation - GenAI, Agentic QMS)
Location - Raritan, NJ(Hybrid)
$50/hr on w2 Job Details:
• Experience in the Pharmaceutical, biotechnology, or medical device industry
• 2+ years' experience with System Development Lifecyle
• 3+ years' experience in Computer System Validation Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.
• Knowledge of FDA guidance's and industry standards (i.e., GAMP)
• Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports
• Experience in QA Methodologies, designing, reviewing and approving User Stories, Test Plans and Reports, System and UAT test scripts, Test procedures, Traceability Matrix, and Design Specs.
• Strong verbal and written communication skills.
• bility to lead a team. Ability to work with remote teams and support several changes/projects simultaneously.
• bility to provide Validation guidance, timely reviews, and escalations to TQ management.
• bility to work with global project teams during the initial project planning phases
• bility to provide guidance on validation strategy and be able to handle the highly fluid state of the project
Location - Raritan, NJ(Hybrid)
$50/hr on w2 Job Details:
• Experience in the Pharmaceutical, biotechnology, or medical device industry
• 2+ years' experience with System Development Lifecyle
• 3+ years' experience in Computer System Validation Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.
• Knowledge of FDA guidance's and industry standards (i.e., GAMP)
• Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports
• Experience in QA Methodologies, designing, reviewing and approving User Stories, Test Plans and Reports, System and UAT test scripts, Test procedures, Traceability Matrix, and Design Specs.
• Strong verbal and written communication skills.
• bility to lead a team. Ability to work with remote teams and support several changes/projects simultaneously.
• bility to provide Validation guidance, timely reviews, and escalations to TQ management.
• bility to work with global project teams during the initial project planning phases
• bility to provide guidance on validation strategy and be able to handle the highly fluid state of the project
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the Validation Lead in Raritan, NJ vacancy
- Validation Lead Raritan, NJ (Remote and Hybrid preferred) W2 Contract Must Have - Computer System Validation - Validation exp. Infrastructure and Tools - AWS/Azure etc. Key Responsibilities: Candidates need to have hands-on experience in validating and implementing infrastructure...SuggestedContract workRemote work
- Piper Companies is seeking a Sr CQV Specialist to support commissioning, qualification, and validation activities for a leading cell therapy manufacturing organization in Raritan, NJ. You will ensure compliant operations, support audits, and mentor junior engineers in a...Suggested
- ...make a meaningful impact on the business.Summary of the RoleThe Senior Director of Civil Engineering - Multi-Site, is responsible to lead and own the performance, growth, and delivery consistency of Core States Group's national multi-site Civil Engineering teams. This...SuggestedRemote work
- ...Description Position Description: Our project managers are technical leads first, with a strong background in CQV strategy, development,... ...800 people worldwide. We provide commissioning, qualification, validation, start-up, project management and other consulting services...SuggestedFull timeWorldwide
$160k - $200k
...hyperscale customersWe are seeking a Principal Optical Engineer to lead the innovation, design, and prototyping of our next-generation... ...of optical systems.Participate in hands-on prototyping and validation activities to ensure strong correlation between design models and...SuggestedFlexible hours- Purple Drive Computer System Validation (CSV) Consultant Share Raritan, NJ Overview: Role Descriptions: • Demonstratable experience in... ...support for 21 CFR Part 11 implementation in Pharma industries. • Leading the Tech Writer team for preparing the test cases. • Co-...
$96.27k - $126.35k
...performed within a team-based environment, on an assigned production shift schedule. Key Responsibilities This individual will lead and supervise multiple units within the CAR-T process operations (i.e. component preparation manufacturing, MFG support operations,...Permanent employmentFull timeTemporary workFor contractorsWork at officeLocal areaWorldwideFlexible hoursShift workDay shiftAfternoon shiftLegend Biotech US
Raritan, NJ16 hours ago- ...The Director of Operations will lead and optimize the operational backbone of a mid to large staffing and consulting organization. This role is responsible for driving operational consistency, margin performance, scalability, and service excellence across sales, finance...Full time
Red Global
Somerville, NJ16 hours ago - ...Operations & Service Management, will set the strategy and direction for PVH's global IT operations and service management organization, leading three direct reports who each own a critical pillar of service delivery: Application Managed Services, Infrastructure and Security...Full timeContract workSeasonal workLocal areaFlexible hours
$59.17k - $77.66k
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous ...Permanent employmentFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hoursShift workAfternoon shiftLegend Biotech US
Raritan, NJ16 hours ago$117k - $201.25k
...discovery data is trusted, connected, and AI-ready as the broader ecosystem evolves.Position SummaryAs a Principal Data Engineer, you will lead the design of discovery data products, scientific data models (schemas, entities, and relationships), and integration requirements...Full timeTemporary workWork at officeLocal areaRemote work$84k - $88k
...background, faith, identity, or circumstance. About the Role We seek a mission-driven, detail-oriented Director of Clinical Operations to lead and grow our operational infrastructure. This role holds key leadership responsibility for the operational strength of JFS programs,...Full timeContract workLocal areaJFS of Somerset, Hunterdon & Warren Counties NJ
Somerville, NJ2 hours ago$164.2k - $218.9k
...and embedded into how work gets done—resulting in faster readiness, stronger adoption, and sustained execution.Key Responsibilities· Lead the diagnosis of workforce readiness, capability gaps, and organizational effectiveness in partnership with HR leaders, aligned to...Full timeTemporary workWork at officeLocal areaRelocation package3 days per week$150k - $175k
...optimize utilization (people, contractors, equipment, materials). Lead preventive maintenance and reliability initiatives, including... ...emergencies and business needs outside normal working hours as necessary. Valid driver’s license. S3 Wastewater License required, S4 preferred...Full timeTemporary workFor contractorsWork at officeLocal areaMonday to Friday- Legend Biotech is seeking a Director, QA Operations as part of the Quality team based in Raritan, NJ. Role Overview The Director of Quality Operations, CAR-T is responsible for Quality oversight and support of cell therapy manufacturing operations, in full compliance with...Permanent employmentFull timeFor contractorsWork experience placementWork at officeLocal areaWorldwideFlexible hoursShift work
$89.2k - $122.6k
.... As such, he/she will: The Role (daily responsibilities) Lead the annual sales target-setting process working closely with the... ...providing key reporting, training, problem-solving, and data validation/review. Perform territory analytics using external market data...Local areaCatalent Inc
Bridgewater, NJ1 day ago- ...and forecast and tracking of study budgets and milestones .Provide periodic updates to the cross-functional team members.The CTM will lead the clinical trial team overseeing all trial activities ensuring timelines are met and budget is managed appropriatelySkills:Strong...Local areaImmediate start
$130k - $165k
Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions... ...accuracy and credibility through strong data governance, validation, continuous improvement, and incorporation of customer and...Temporary workWork at officeRemote workWork visa2 days per week3 days per week- ...in Oncology is mandatory.• CTOM needs to be able to review and validate patients and data.• Strong interpersonal and communication skills... ...systems), processes and SOPs • Experience in managing and leading international meetings (Clinical Trial Team, expert meeting, etc...Immediate startFlexible hours
- Company DescriptionArtech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets...Work at officeLocal areaImmediate start
$167.76k - $212.83k
...Impact:Sets the strategy and operating model for commercial operations, analytics, field enablement, and data-driven decision making.Leads the development, effectiveness and maintenance of field CRM systems, and leads their use in enabling field force efficiency.Advises...Remote workOverseas- ...Validation Specialist, Computerized SystemsThe Validation Specialist, Computerized Systems, is responsible for performing initial and routine validation activities for GxP computerized systems. Primary responsibilities include: qualification of laboratory instruments,...Work experience placement
Omni Inclusive
Warren, NJ2 days ago - ...of the vehicle reconditioning process and directs at least five leads and up to 70 front line associates in a lean manufacturing environment... ...understand English. ~ Must be at least 18 years of age. ~ Valid unrestricted driver's license with a clean driving record in the...Weekend workAfternoon shift
Carvana
Manville, NJ1 day ago $104k - $165k
Join to apply for the Civil Engineer - Project Manager role at Van Cleef Engineering Associates, LLC Van Cleef Engineering Associates, LLC (Van Cleef) is a dynamic, multi‑disciplined consulting civil engineering firm of Engineers, Certified Inspectors, Landscape Architects...Work at officeLocal areaVisa sponsorshipFlexible hours- ...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 responsibilities include project...Remote work
$117k - $201.25k
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise...Full timeTemporary workWork at officeLocal areaRemote work$130k - $160k
...and make an impact at Henkel. What youll doDefines and steers sales, sales structures, key customers and new business to drive growth Leads execution of global/regional sales plans based on market needs, trade structure, competitive situation aligned with SBU/SU...Minimum wageLocal areaFlexible hours- Everest Clinical Research in the USA is seeking a Senior Manager, Clinical Operations to lead the Clinical Operations team and ensure timely delivery of study milestones. This on-site role in Bridgewater, NJ also offers remote work options under our Work from Home policy...Remote jobWork from home
- Legend Biotech USA is looking for an experienced Operations Associate to join the Technical Operations team in Raritan, NJ. This exempt position supervises the daily production of personalized cell therapy in a sterile cGMP environment, ensuring compliance and efficient...Work at office
- Somerset Regal Bank is seeking an on-site Operations Assistant in Bound Brook, NJ. You will provide in-person, email and phone support for Operations, handle daily DDA rejects, and manage various adjustments and check processing tasks. You will generate analytics reports...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Validation Lead. Be the first to apply!
Related searches