Computer System Validation Engineer

Job Title: Computer System Validation Engineer

Location: Bothell, WA

Pay Rate: $85-$90

Key Responsibilities

· Author, review and/or approve applicable CSV documentation

· Assist Business Owners and Technical Owners during test execution, document test failures and ensure testing aligns with internal procedures

· Assist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations

· Other related duties as assigned

Team Structure – how does this role fit with the team This role is an individual contributor and will cross-functionally to lead and execute validation activities for GxP electronic systems and application.

Role in Team This individual will partner with Business Owners, Technical Owners, and Quality to create and manage validation deliverables for electronic systems and applications throughout the validation lifecycle. The CSV Contractor has primary responsibility to ensure that the tasks supporting validation of Manufacturing Execution Systems (MES) and other computerized systems are documented in accordance with the relevant Client procedures and regulations.

Must-have Qualifications • GMP manufacturing experience

• Flexibility to work as per Shift Schedule
• Adheres to Good Manufacturing Practices and standard operating procedures.
• Completes work instructions and maintains clean room environment to comply with regulatory requirements.
• Primary focus on MES validation knowledge

Nice-to-have Qualifications Familiarity with MES systems (i.e.

Emerson

Syncade), ERP systems (i.e. SAP or Oracle) and EBRs (i.e. InfoBatch).

Technical Skills Computer system validation (document and protocol generation, execution)

Non-Technical Skills Good communication, self project management

Additional Standout Experience Strong knowledge on development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ or equivalent], Summary Reports, Trace Matrices, SOPs, etc.)

Experience

Field Details

Required Experience At least 3 years in CSV

Preferred Experience 4 years in CSV

Overqualified Indicators / Similar Titles Management of CSV engineers, performing only review and approval of validation documents

Target Companies Open to review profiles from companies with CSV exp.

Education & Certifications

Field Details

Education Required Bachelor's degree in a life sciences or engineering / IT discipline or equivalent industry experience (a combination of industry-specific education

Education Preferred N/A

Certifications Required N/A

Certifications Preferred N/A