Senior Validation Engineer​/Lead

Summary

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.

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.

• Automation.
• Business Continuity.
• Change Control.
• General Hse Knowledge.
• Including Gdp.
• Knowledge Of Capa.
• Knowledge Of Gmp.
• Managing Performance Improvement.
• Manufacturing (Production).
• Project Commissioning.
• Project Engineering.
• Project Execution.
• Risk Management.
• Root Cause Analysis (Rca).