Senior Validation Engineer / Lead

Novartis•Durham, NC

3d•Onsite

About The Position

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.

Requirements

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.

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