Job Description

Scope of Role & Responsibilities:

The Senior Validation Engineer, working under the direction of the Project and Validation Managers, will be responsible for the following:

• Draft, lead reviews, and approve Engineering Commissioning protocols (FAT, SAT, etc.) and validation protocols (IOQ and PQ) to support new manufacturing line installation.
• Support the execution of IOQ and PQ protocols.
• Expertise in equipment validation and Computer System Validation.
• Manage, track, and lead closure of discrepancies and deviations in executed validation protocols.
• Draft, lead reviews, and approve validation summary reports.
• Support vendor activities on-site during installation, commissioning, SAT, and pre-IOQ protocol executions.
• Develop and execute validation protocols.
• Participate in project team meetings.
• Provide periodic progress reports and status updates to Project and Validation Managers.
• Work with the data integrity team to ensure compliance in validation activities.
• Strong knowledge in writing Validation Documents (e.g., Validation Master Plans) and working knowledge of statistical analysis.

Qualifications:

• Education: Bachelor's degree in Engineering or Life Sciences.
• Experience: 7 - 10 years of experience in pharmaceutical API commissioning and validation.
• Preferred: Experience working in a capital project environment.
• Regulatory Knowledge: Thorough understanding of cGMP and FDA regulations.
• Technical Skills: Hands-on experience in writing and executing IOQ/PQ protocols.

Soft Skills:

• Strong communication skills (open, direct, timely, transparent, and factual).
• Self-driven, self-managed, self-reliant, and dependable.
• Ability to work effectively in high-performance teams and under schedule constraints.

Hands-On Validation Experience With:

• Cleanrooms: Classified Cleanrooms (Grade C and D)
• Equipment & Systems:
• ○ Autoclaves
• ○ Glassware Washers
• ○ Control Room Temperature (CRT) Chambers and Rooms
• ○ 2-8°C Refrigerators
• ○ -20°C Freezers
• ○ Ultra-Low Freezers
• ○ Blast Freezers
• ○ Reactors
• ○ Utility Skids
• ○ WFI (Water for Injection) Systems
• Software & Programs: Paperless Validation Programs

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