Senior Validation Engineer
Katalyst Healthcares and Life Sciences
Roles & Responsibilities:
- Lead/Support aVeeva LIMS implementation and the validation activities throughout the system lifecycle, from requirements and design through testing, deployment, and validation closeout
- Develop and/or review validation deliverables, including URS, risk assessments, validation plans, test scripts, traceability matrices, validation summary reports, and SOPs
- Partner with Quality, Laboratory, IT, Business Process Owners, and system stakeholders to define requirements and ensure the LIMS meets business and regulatory needs
- Support Veeva LIMS configuration, functional testing, integration testing, user acceptance testing, and defect resolution
- Apply risk-based CSV/CSA principles and applicable GxP requirements to ensure the validated state of the system is maintained
- Support data migration, interfaces, integrations, and related systems as part of the LIMS implementation
- Participate in system change control, deviations, CAPAs, periodic reviews, and other lifecycle activities following implementation
- Provide technical and validation expertise during implementation meetings, workshops, testing activities, and issue resolution
- Ensure validation activities comply with applicable regulatory expectations, company procedures, and industry practices such as GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity principles
- Support inspection and audit readiness by ensuring complete, accurate, and traceable validation documentation.
- Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related technical discipline
- 5+ years of experience in computerized system validation, quality, or validation engineering within pharmaceutical, biotechnology, or other GxP-regulated environments
- Demonstrated experience with Veeva LIMS implementation, validation, or lifecycle management
- Strong understanding of CSV/CSA methodologies, GxP requirements, risk-based validation, and data integrity
- Experience developing and executing validation/testing documentation, including requirements, risk assessments, test protocols/scripts, traceability, and validation reports
- Strong understanding of 21 CFR Part 11, EU Annex 11, GAMP 5, and applicable data integrity principles
- Strong project management, organizational, communication, and problem-solving skills
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Senior Validation Engineer in Blacklick, OH vacancy
- ...quality compliance reviews under cGMP guidelines. The role involves auditing critical equipment, utilities, analytical data, and validation reports across laboratory and production environments, with minimal supervision. The incumbent will support QA project teams, manage...Senior
- 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, Compliance, Computer, Engineering...Suggested
- Validation & Engineering Group, Inc. is seeking a Junior Validation Specialist with 0-3 years of experience to support commissioning, qualification, and validation activities at a biotech manufacturing site. The role involves validation documentation and execution in a...Suggested
- Validation & Engineering Group, Inc. is seeking a junior validation specialist to support commissioning, qualification, and validation activities at a biotech manufacturing site in a regulated GMP environment. The role emphasizes documentation, testing, data collection...Suggested
- A leading engineering consultancy is seeking a Senior Building Physics Engineer in Ohio to support nationwide projects. Responsibilities include delivering building physics workstreams, developing energy strategies, advising on low-carbon design solutions, and collaborating...Senior
- ...Senior Automation Engineer HonorVet Technologies is a Service Disable Veteran-Owned IT staffing firm, ISO 9001 and ISO 27001 certified, working... ...role will lead the design, commissioning, qualification, validation, startup, and operation of automated cold storage and...Senior
HonorVet Technologies
New Albany, OH2 days ago - Reveleer is seeking a Senior Systems Engineer to own the reliability and security of a hybrid cloud environment, driving automation and AI-enabled workflows. You will design and implement intelligent infrastructure, integrate MCP-based tooling, and partner with DevOps,...Senior
- ...Job Description Job Description Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance,...
- ...Senior Accountant New Albany, OH 43054 Salary Range- $85,000-$100,000 Ready to take the next step in your accounting career? We're partnering with a respected organization in New Albany that is looking to add a Senior Accountant to their team. As a Senior...Senior
Creative Financial Staffing
New Albany, OH15 hours ago $87.63k - $109.54k
...Experience:Bachelor’s degree in construction management, Engineering, Business, Project Management, Computer Science,... ...PMP certification is preferred but not required.Valid state driver's license is required.Project Manager Senior SG8Education/ExperienceBachelor’s degree in...SeniorContract workFor contractorsWork from homeHome office$87.63k - $109.54k
## Transmission Right of Way Agent- Senior-Principal-StaffApplylocations: New Albany, OHtime... ...:* Associate’s degree in business, engineering, paralegal, real estate or related field... ...accommodate project schedules. Must have a valid driver’s license issued by the...SeniorFor contractorsWork at office- Amentum is seeking a General Maintenance Technician II in New Albany, Ohio to join our operations and maintenance team. This intermediate technician will respond to work orders, troubleshoot, and repair fixtures and systems in a critical infrastructure environment. Working...Senior
- AEP Service Corporation, based in New Albany, OH, seeks a leader to manage the Transmission Planning organization for the Appalachian Power region. You will oversee planning studies, define system needs, and develop cost-effective solutions to maintain reliability and balance...Senior
- Aquent is seeking a seasoned Merchant or Buyer for a six-month maternity leave coverage in its third-party wholesale Swim and Apparel business. You will own the assortment strategy, drive line plans, and partner with design, product development, and manufacturing to meet...Senior
- Victoria’s Secret in Reynoldsburg, OH, seeks a Senior Accountant who will be an individual contributor in the North America Stores Financial Reporting team. You will prepare journal entries, balance sheet reconciliation schedules, and analyze accruals to determine the...Senior
- The Avalon Of New Albany is seeking a hospitality-focused LPN to join our team. This role provides direct nursing care to residents and supervises the care provided by our Quality of Life Specialists/Resident Assistants. Key responsibilities include monitoring resident ...Senior
- Solomon Page is seeking a Demand & Deployment Analyst for a leading fashion retailer in Columbus. The Sr D&D Analyst will execute pre-season and current-season inventory deployment to support store inventory, drive sales and maximize margin through optimized assortments...Senior
- HRB is seeking a Sr. level Scrum Master to lead agile teams, ensure sprint goals are met, and uphold delivery commitments. You will facilitate ceremonies, drive collaboration across business and IT, and navigate ambiguity with confidence in a fast-paced ecommerce environment...Senior
- A leading energy company in New Albany, OH is seeking a Land Specialist to negotiate contracts, manage titles, and supervise lease brokers. The ideal candidate has a Bachelor's degree and over 10 years of experience in land and contracts, with strong negotiation and interpersonal...Senior
- Surge Staffing is seeking an experienced Senior Accountant to join a growing manufacturing organization. This role will support financial reporting, reconciliations, inventory accounting, internal controls, and operational financial analysis across multiple facilities....Senior
- The Avalon Of New Albany is actively recruiting a hospitality-focused LPN to join our team in New Albany, Ohio. This role provides direct nursing care to residents while supervising the care provided by Quality of Life Specialists and Resident Assistants. Responsibilities...Senior
- Victoria’s Secret & Co. is seeking a Sr. Assortment Planner to generate and analyze data for a multi-million-dollar category, focusing on assortment and space optimization. You will revise tier targets, develop financial views, and use space productivity metrics to guide...Senior
- Victoria's Secret in Reynoldsburg, OH is seeking a Financial Reporting Specialist to support Duty activities within Supply Chain. The role involves managing the general ledger, monthly closings, journal entries, reconciliations, and variance analysis to produce accurate...Senior
- Victoria's Secret in the United States is seeking a Sr. Assortment Planner to generate and analyze data for a multi-million-dollar category, focusing on assortment and space optimization. You will revise tier targets, develop a financial view of style and choice counts,...Senior
- Bechtel Global Corporation in New Albany, Ohio is looking for a Subcontract Administrator to oversee subcontract formation and administration. You will lead contract development, ensure compliance with project requirements, and manage communication with stakeholders. The...SeniorContract workWork experience placement
- Eightelevengroup is seeking an experienced Business Analyst to lead the integration of Global Trade, Supply Chain, IT, and vendor teams for complex enterprise system deployments. You will elicit and document requirements, map current and future processes, and translate ...Senior
- ...field activities, oversee inspections, and ensure design conformance to drawings, specs, and codes. You will collaborate with design engineers and fabricators, develop work packages, and manage field changes while supporting safety and quality programs on a #J-18808-...Senior
- ZSG is seeking a Supply Chain Manager to oversee production planning, material availability, inventory, supplier delivery, and logistics in a fast-paced automotive manufacturing environment. You will lead and develop the supply chain team while ensuring materials move efficiently...Senior
- Amgen in New Albany, OH, is seeking a Manufacturing Senior Associate to manage a device assembly & packaging line in a cgmp environment... ...writing SOPs, CAPA support, and collaborating with Quality, Engineering and Mfg to resolve issues while driving continuous improvement...Senior
- The Avalon Of New Albany is recruiting a hospitality-focused LPN to join our team in New Albany, Ohio. This role provides direct nursing care to residents and delegates and supervises the care provided by our Quality of Life Specialists and Resident Assistants. Daily duties...Senior
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Validation Engineer. Be the first to apply!
Related searches
- senior software engineer remote Blacklick, OH
- senior performance engineer Blacklick, OH
- senior performance tester Blacklick, OH
- senior ux designer remote Blacklick, OH
- senior vice president of operations Blacklick, OH
- srs Blacklick, OH
- senior manager legal Blacklick, OH
- remote senior salesforce administrator Blacklick, OH
- senior financial analyst fp&a Blacklick, OH
- senior network engineer remote Blacklick, OH