Sr. Validation Engineer - OQSIE

Scope of Role & Responsibilities: Work under the direction the Project and Validation Managers, the Senior Validation Engineer will:

• Draft, lead reviews and approval of Engineering Commissioning protocols (FAT, SAT etc.) and validation protocols (IOQ and PQ protocols) to support new manufacturing line installation.
• Support Execute the IOQ and PQ protocols.
• Have expertise in equipment validation and Computer System Validation
• Manage, track and lead closure of discrepancies and deviations of executed validation protocols
• Draft and lead reviews and approval of and validation summary reports
• Support vendor activities on Site during installation, commissioning, SAT and pre-IOQ protocols executions.
• Support updating project ESD (Engineering Specification Document) and related SOP's
• Develop and execute validation protocols to run new autoclave cycle for new machine parts.
• Participate in project team meetings.
• Provide periodic progress reports and status updates to Project and Validation Managers.
• Provide technical and compliance expertise to write SDLC documentation in accordance with local procedures, templates, regulatory requirements (21 CFR Part 11, 211, 820), and IT Security Standards. Track and execute computer system Periodic Reviews, User Account Reviews, and other computer system compliance processes as assigned.
• Validation Protocols, Associated SOPs, Part 11 Risk Assessments, Verification Plans, Test Scripts).Work with the data integrity team to ensure compliance in creation and execution of validation activities.
• Excellent knowledge in writing Validation Documents (e.g. Validation Master Plans,
• Working knowledge of statistical analysis – Six Sigma Green Belt or equivalent.

Qualifications:

(1) BS in Engineering or Life Sciences.

(2) Minimum 7 - 10 years of experience in pharma and medical devices commissioning and validation.

(3) Experience working in capital project environment – desired.

(4) Thorough knowledge in cGMP and FDA regulations.

(4) Strong technical skills.

(5) Hands-on-experience writing and executing IOPQ protocols.

(6) Strong communication skills (open, direct, timely, transparent and factual).

(7) Self-driven, self-managed, self-reliant and dependable.

(8) Works well in high-performance teams and schedule constraints.

(9) Six Sigma Certified (Greenbelt) or equivalent – desired.