Specialist, Validation

Job Description

The Validation Specialist serves on project teams in support of complex capital, compliance, and contract projects while demonstrating expert technical validation expertise. The Validation Specialist also leads and assists in the execution and documentation of validation work to ensure critical production equipment meets satisfactory performance standards.

Leads and executes equipment requalifications and performance qualifications on critical production equipment and other validation work as needed. Authors equipment requalification reports to provide documented evidence of equipment requalifications. Updates program and policy documents for requalification of new equipment. Authors SOPs for requalification of new equipment. Revise validation SOPs to ensure correct and up to date information and processes are followed.

Demonstrates a working and theoretical knowledge of the operation of various equipment and systems such as lyophilizers, terminal sterilizers, tanks, autoclaves, dry heat ovens, rinsers, CIP and SIP systems, HVAC, aseptic processing areas, etc. Initiates deviations within the EQMS system. Assist with RCA and authors impact assessments. Completes minor deviations. Authors and approves change controls and CAPAs. Authors validation protocols and reports, developing validation strategies for validation projects. Demonstrates knowledge of validation principles and regulatory and industry standards and ensures their application in strategy and approach.

Responsible for working interdepartmentally to ensure IQ/OQ/PQ of new equipment is complete.

Qualifications

• BS Degree (hard science) 3 years validation experience (1 years with MS Degree)
• Proficiency in standard business computer applications (i.e. Microsoft Outlook, Word, Excel, PowerPoint, etc.)
• Proficiency with EQMS, LMS, and EDMS
• Technical writing
• Mechanical aptitude

Benefits

• Hiring Wage: $84,300 – 134,900, with opportunities for growth, promotion, and annual raises.
• Starting on your first day, you receive: Medical, Dental & Vision coverage
• Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA)
• Life & AD&D Insurance
• Short-Term & Long-Term Disability Insurance
• Employee Assistance Program

Working Environment

• Ability to lift 50 lbs.
• Prolonged sitting, prolonged standing, exposure to allergens, working in confined spaces, working in aseptic areas, repetitive activity.
• Occasional evenings and weekends.

Location

Spokane, WA — On Site, Full-Time Shift: Weekday Days