Senior Technical Operations Validation Specialist

The Senior Technical Operations Validation Specialist is the subject matter expert for various types of technical responsibilities within the scope of the pharmaceutical quality unit. They establish that all computerized systems are functioning as intended and designed, and ensure that all written procedures and practices are in place for computerized systems.

Requirements

• Create validation protocols for processes, equipment, cleaning procedures, facilities, and computerized systems.
• Serve as system administrator and technical SME responsible for ensuring systems are qualified and functioning as intended.
• Provide primary technical support for QC laboratories for analytical method development, problem-solving, and validation.
• Configure and test software such as Quality Control Laboratory Information Management System (LIMS), Chromatography Data System (CDS) and other QC computerized systems.
• Prepare and compile data to analyze test information to determine process or equipment operating efficiency or to diagnose malfunctions.
• Study chemical compounds and use research to support the development of products or processes.
• Subject Matter Expert (SME) for supporting risk assessments for any product quality inquiries, calculations of formulation content, and/or supports the assessment of any potentially applicable emerging risks as may be identified within the pharmaceutical industry.

Benefits

• 401k Matching
• Retirement Plan
• Visa Sponsorship
• Four Day Work Week
• Generous Parental Leave
• Tuition Reimbursement
• Relocation Assistance