Senior Validation Engineer / Lead

Novartis-posted 10 days ago
Full-time • Mid Level
Onsite • Durham, NC
5,001-10,000 employees
Resume
Match Score
Upload and Match ResumeTrack Jobs with Teal

The Senior Validation Engineer is a subject matter expert in the Commissioning and Qualification program and provides leadership and mentorship in the qualification of equipment, utilities, and processes. Location: Durham, NC Please note this role is on-site 5 days a week and does not have the ability to work remotely. This role is based in Durham, NC. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

  • 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
  • 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.
  • US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits.
  • In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
Track Jobs with Teal

Job Search Resources

•
AI Resume Builder
•
Validation Engineer Resume Examples
•
Cover Letter Examples

Tools

Career Hubs

Guides

Company

© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service