Senior Validation Engineer

The Senior Validation Engineer will be responsible for activities related to the lifecycle of qualified equipment and systems, ensuring validation and calibration activities meet requirements to maintain regulatory compliance. The position will require hands-on equipment calibration and validation activities, and the supervision of validation/calibration contractors.

Responsibilities:

• Follow all validation and calibration Policies
• Ability to assess and evaluate various types of laboratory equipment for proper validation and calibration requirements
• Monitor and Trend validation and calibration data
• Supervise/escort contract service providers when necessary
• Work closely with Quality, Process Development, Facilities, and Production to investigate and resolve deviations associated with equipment calibration
• Assist in providing responses to audit observations and CAPA commitments related to validation and calibration activities
• Authors in-house validation protocols. Reviews validation and calibration protocols and certificates
• Author/Assist in the development, writing, and revising of calibration related Standard Operating Procedures (SOP), forms, specifications and other required documents
• Maintain validation and calibration standards
• Ability to work within cleanroom environments to perform validation/calibration activities

Qualification Requirements:

• 3 or more years of relevant experience in validation activities in a biopharmaceutical manufacturing environment
• Able to follow validation procedures in order to perform validation activities
• Able to communicate efficiently and effectively among VCM team members, other PaxVax department members, and any outside contract service providers/vendors
• Proven collaboration skills, learning agility, conceptual and strategic thinking, passion for results, and ability to navigate ambiguity

Technical Skills and Knowledge:

• GMP calibration experience associated with process equipment, utilities, and laboratory equipment
• Proven skill in performing validation checks for various types of equipment and instrumentation used in research and manufacturing
• Experience with deviations and investigations into validation/calibration failures and determination of product impact potential, root cause, and corrective actions
• Excellent technical writing and verbal communications skills
• Ability to read/interpret engineering drawings and design documents
• Ability to work as part of a high performing team and collaborate effectively with staff at all levels
• Demonstrates ability to execute multiple activities while maintaining a high level of organization
• Demonstrates initiative, ability to undertake additional responsibilities and respond to situations as they arise with little or no supervision.
• Ability to make independent sound decisions and independently manage priorities in alignment with department and company goals.