Novartis · 21 hours ago
Senior Validation Engineer
Durham, NC
Full-time
Onsite
Mid, Senior Level
$108K/yr - $202K/yr
7+ years expNovartis is a global healthcare company that is seeking a Senior Validation Engineer who will serve as a subject matter expert in the Commissioning and Qualification program. The role involves leading and mentoring in the qualification of equipment, utilities, and processes, while ensuring compliance with regulatory standards.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Develops a tailored approach for each project they are assigned including assessing vendor validation packages, performing gap analysis to User Requirements, developing plans and protocols using a risk-based approach that comply with company policies and procedures, and completing trace matrices
Reports on progress and roadblocks to the project team(s)
Develops Commissioning and Qualification policies and procedures to enhance the company’s ability to conform to and maintain compliance with site, corporate and regulatory standards
Development, execution, and management of small to medium size projects
Manages CQV contractors to perform tasks as required
Authors and/or manages authoring of commissioning, qualification and validation plans, validation protocols, validation summary reports and requirement trace matrices
Validation using risk-based approach (FMEA, PHA, etc.). Performs risk assessments to confirm safe and compliant designs and recommend additional controls
Reviews project documentation (URS, FRS, Technical Specifications, Functional Specifications)
Participates in discussions with internal business partners on priorities, timelines and transparent sharing of information
Partners with Quality to ensure a quality and compliant manufacturing environment
Manages workload to ensure timely approval of validation testing and documentation
Supports the validation department during inspections or audits as a Subject Matter Expert
Other related duties as assigned
Qualification
Required
BS/MS degree in Chemical, Industrial, Mechanical, or other related engineering/science discipline with 7 years of relevant engineering experience supporting GMP operations
7 years of experience in the engineering design and support or qualification of commercial grade pharmaceutical or biotechnology process equipment and utilities
Ability to read/interpret engineering drawings and design documents
Excellent technical writing and verbal communication skills
People oriented and a team player
Proficient in Microsoft Word, Excel, PowerPoint, and Project
In-depth knowledge of FDA and EMEA regulations particularly 21 CFR part 11, 210, 211, Annex 1
Working knowledge of ICH Q8, Q9, Q10 and other international regulatory requirements
Familiarity with the following equipment: bioreactors, centrifuges, laboratory systems, TFF systems, chromatography skids, fillers, autoclaves, parts washers
Experience managing 3rd parties (both in-sourcing and outsourcing)
Ability to prepare contingency plans and logically work through complex issues in a high-pressure situation
Benefits
Health, life and disability benefits
A 401(k) with company contribution and match
A variety of other benefits
A generous time off package including vacation, personal days, holidays and other leaves
Company
Novartis
Novartis is a pharmaceutical company that researches and develops medicines for serious diseases to improve and extend people's lives.
10001+ employees
H1B Sponsorship
Novartis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (27)
2023 (23)
2022 (27)
2021 (31)
2020 (25)
Funding
Current Stage
Public CompanyTotal Funding
$2.49BKey Investors
Bill & Melinda Gates Foundation
2024-06-19Post Ipo Debt· $2.49B
2018-02-14Grant· $6.5M
2000-05-19IPO
Leadership Team
Daniel Grant
Vice President & Global Program Head
John von Brachel
VP, Head of Content Lab
Recent News
2026-01-08
2026-01-08
Company data provided by crunchbase