What are the responsibilities and job description for the Validation Engineer II position at Anika?
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 :
Desired Experience, Knowledge, and Skills :
