Computer System Validation Engineer

Computer System Validation Engineer

Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for a Computer System Validation Engineer for our client in Bothell, WA. ECLARO's client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you're up to the challenge, then take a chance at this rewarding opportunity!

Position Overview:

• The Computer Systems Validation (CSV) Contractor works cross-functionally to lead and execute validation activities for GxP electronic systems and applications.
• This role is an individual contributor.
• The CSV Contractor 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) are documented in accordance with the relevant Client procedures and regulations.

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

Required Qualifications:

• Ability to effectively communicate with both technical and non-technical team members.
• Strong interpersonal skills, especially regarding team work, client focus, verbal and written communication
• Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices.
• Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Biologics and clinical manufacturing.
• Knowledge of IT service management platforms to support incident, problem and change IT operational events (i.e. ServiceNow).
• Knowledge and exposure to Business Quality Management Systems (i.e. Veeva).
• Strong technical and problem-solving skills and the ability to work independently.
• Demonstrated success working in a high-performing, business results-driven environment.
• Understanding of computer system validation.
• Familiarity with MES systems (i.e. Emerson Syncade), ERP systems (i.e. SAP or Oracle) and EBRs (i.e. InfoBatch).
• Understanding of computer system validation (CSV).
• Bachelor's degree in a life sciences or engineering / IT discipline or equivalent industry experience (a combination of industry-specific education and work experience may be used to substitute this degree requirement) 4+ years of direct experience with CSV activities, strong knowledge of GAMP / risk-based approaches to validation and good understanding of electronic records and signatures
• Strong knowledge on Manufacturing Execution System (MES) validation.
• Strong knowledge of regulations, current industry practices, and experience with application of guidelines and regulations related to control of computerized systems, electronic records / signatures
• 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.)

Pay Rate: $76.61-$81.25/Hour If hired, you will enjoy the following ECLARO Benefits:

• 401k Retirement Savings Plan administered by Merrill Lynch
• Commuter Check Pretax Commuter Benefits
• Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO

Equal Opportunity Employer: ECLARO values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status, in compliance with all applicable laws.