Position Scope:

Performs start-up, commissioning, qualification, validation and revalidation for facility, equipment, critical utility, automation/computer system, cleaning, sterilization, medical device and drug product manufacturing processes.

Strategic Focus Areas:

Develops into a subject matter expert in cleaning and sterilization validation.

Specific Tactical Responsibilities:

• Authors, executes, and summarizes qualification and validation protocols.
• Conducts Risk / Impact Assessments and establishes system boundaries.
• Ensures protocols, records, and procedures are in compliance with current Good Manufacturing Practices (cGMP), industry standards and approved SOPs.
• Provides technical input in determining strategy for validation activities.
• Represents validation during site GMP activities and participates on cross-functional teams.
• Coordinates the investigation and impact assessment for all deviated equipment or processes discovered upon calibration or validation.
• Initiates, or provides validation input on quality systems such as CAPAs and change controls.
• Responsible for other duties and projects as assigned

Job Complexity:

The job requires the ability to act on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. The position exercises broad judgment within generally defined procedures and practices to determine appropriate action and exercises

Supervisory Responsibilities:

None

Required Qualifications:

• BS degree in engineering or scientific discipline.
• 3-5 years of validation experience in bio/pharmaceutical, medical device or FDA regulated environments.

Desired Experience, Knowledge, and Skills:

• Knowledge of the fundamentals of Steam Sterilization and Cleaning Validation.
• Knowledge of quality risk management and statistical tools within the context of validation.