Job Description

Job Description: Senior Validation Engineer

Work Location: East Windsor, NJ(Onsite)

Position Summary:

Validation Engineer Ill ensures compliance by validating systems, equipment, and processes while managing the lifecycle of Computer System Validation and cross-departmental projects. This role drives technical transfers, leads continuous improvement initiatives, and supports audits to enhance efficiency and maintain regulatory standards.

Key Responsibilities:

• Ensures compliance by validating facilities, equipment, systems, and processes while authoring and approving commissioning and validation documents for sterile and non-sterile manufacturing.
• Manages the lifecycle of Computer System Validation, executes multiple protocols, and analyzes data to create reports, including deviations.
• Coordinates cross-departmental validation activities, tracks timelines and budgets, and drives technical transfers across Empower sites.
• Leads continuous improvement through quality investigations, Corrective and Preventive Actions, Risk Assessments, Change Control, and staff training.
• Provides expertise during audits, manages contractors for Commissioning, Qualification, and Validation (CQV), and develops cleaning, sterilization, and process cycles.
• While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel to access, input, and retrieve information from the computer and other office productivity devices.
• The employee is regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and stoop, kneel, crouch, or crawl.

Mandatory Qualifications:

• Bachelor of Science degree in a scientific or engineering discipline.
• 10 years of Validation experience in the pharmaceutical or biotechnology industries.
• Advanced knowledge in current good manufacturing practices, CQV, sterilization validation, Good Automated Manufacturing Practice, 21 Code of Federal Regulations Part 11, and experience with Computer System and Cleaning Validation.
• Strong project management, problem-solving, and analytical skills with attention to detail and proficiency in Microsoft Office and Quality Management Systems.
• Certified Quality Engineer Preferred.
• Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions.
• Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement.
• Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.
• Resourcefulness: Secures and deploys resources effectively and efficiently.
• Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems.
• Ensures Accountability: Holds self and others accountable to meet commitments and objectives.
• Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations.
• Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.

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