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 5 hours 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) 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, Project Management...Suggested
Validation and Engineering Group, Inc
New Albany, OH1 day ago - 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. (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 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
- ...Sr Manufacturing Engineer At Bath & Body Works, we believe everybody deserves to feel... ...help create feel good moments every day. Senior level individual contributor position focused... ...development to production Assess and validate batching, filling, labeling and pack-out...SeniorFull timeHome officeShift work
Bath & Body Works
New Albany, OH2 days ago - ...place to work . The Position We are seeking a Senior Automation & Manufacturing Engineer to serve as the site leader for manufacturing technology... ...Tests (SAT), startup activities, and performance validation. Ensure capital projects achieve targeted business...SeniorFull timeContract workLocal areaFlexible hours
Alene Candles Midwest LLC
New Albany, OH9 days ago - 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
$99k - $129k
...assigned supervisor for performing advance engineering work activities and projects requiring... ...model-building process. Develop, validate and maintain dynamic models to support transient... ....What we’re looking for:Engineer Senior - (SG8)Has typically acquired 4 or more...SeniorFull time$96.11k - $124.94k
...Technology.This position would be supporting/engineering in the Operational Technology networks... ...we’re looking for: Telecom Consultant Senior SG8Education: Bachelor's degree in... ...mentioned above.Licenses/Certifications: Valid Driver's License Required. Telecom Consultant...SeniorFull timeWork experience placementWork at office- ...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, OH19 hours 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
- ...help create feel good moments every day.Senior level individual contributor position focused... ...development to production• Assess and validate batching, filling, labeling and pack-out... ...Initiate, research and implement value engineering principles to reduce costs, lead time...SeniorLocal areaHome office
- ...Defense Logistics Agency in Columbus, OH seeks an Attorney-Adviser (Contract) to serve as Senior Contracts Counsel and Team Leader for a contract team. You will advise on large-scale acquisitions, provide risk assessments, and support litigation before GAO and Federal...SeniorContract work
Defense Logistics Agency
Whitehall, OH3 days ago $145k - $155k
...department collaborates with Operations, Sales, Engineering, Information Technology and Management... ...an ambitious, detail-oriented, hands-on Senior Automation Systems Engineer to leadSCADA... ...troubleshooting, commissioning, and validation activities in live, mission-critical...SeniorTemporary workFor contractorsWork at officeLocal areaRemote workFlexible hoursVantage Data Centers
New Albany, OH3 days ago- A global data center provider seeks a Chief Engineer for their facility in New Albany, Ohio. The role entails site management, maintenance, and ensuring compliance with safety regulations. Candidates should have over 10 years of experience in mission critical environments...Senior
$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- ...of experience in Java ~ Spring Boot framework experience ~ Docker/Kubernetes experience ~ Elastic Search for building search engines Required Skills : Java, Spring Boot, APIs, CI/CD, Docker/Kubernetes, Elastic Search. Ecommerce background, Elastic Search...SeniorLocal area
My3Tech Inc
New Albany, OH23 hours ago - EOG Resources in Ohio seeks an experienced cost accountant to develop a well‑rounded knowledge of the Company's operations, cost accounting processes, and COPAS guidelines, with emphasis on capital and operating expenditures, lease accounting, data analysis, and cost allocation...Senior
EOG Resources
New Albany, OH3 days ago - Zuckerman’s Pest Management is looking for a highly skilled Wildlife Trapper & Exclusion Expert to join their team in Reynoldsburg, Ohio. This full-time position offers competitive hourly pay plus sales commissions, paid time off, and opportunities for personal development...SeniorHourly payFull time
Dormont Manufacturing Company
Reynoldsburg, OH3 days ago - ...Senior AccountantReady 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 Accountant, you’ll work closely with finance leadership and help support...Senior
Creative Financial Staffing
New Albany, OH5 days ago - ...a multi-building mega-site, coordinating across construction, engineering, procurement, and commissioning. The role reports to the Site... ...planning, and safety. It involves interfacing with the client and senior leadership to ensure safe, on-time turnover. #J-18808-Ljbffr...Senior
Bechtel Global Corporation
New Albany, OH1 day ago - 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
- Odyssey Logistics seeks a Sr. Import Entry Writer in Reynoldsburg, Ohio. This role involves accurately preparing and managing U.S. Customs import entries with an emphasis on compliance. Candidates should have 7-10 years of experience and a deep understanding of Customs ...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
- Everest Technologies, Inc. in New Albany, OH is seeking a senior Scrum Master with a proven track record to lead agile teams, facilitate ceremonies, and ensure delivery of sprint commitments. The role emphasizes strong communication across business and IT stakeholders...Senior
- A leading technology firm in Ohio seeks a Field Technician to manage installations and maintenance. The role involves troubleshooting various systems and ensuring compliance with safety protocols. Ideal candidates have significant experience in electronics and solid communication...Senior
- Spectraforce Technologies in New Albany, Ohio is seeking a Network Engineer V to lead program‑level networking initiatives for a 12‑month engagement. The role focuses on deployment oversight, reporting, and driving escalations to meet deadlines while shaping deployment...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
- 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
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Validation Engineer. Be the first to apply!
Related searches
- senior operations technician Blacklick, OH
- process validation engineer
- analog mixed signal ams verification engineer
- hil validation engineer
- pharmaceutical validation engineer
- senior design verification engineer
- validation officer
- cleaning validation specialist
- software verification engineer
- senior validation engineer