Computer Systems Validation Engineer

Orion Innovation; Bothell (WA); On-site; USD 120,000 - 160,000; Full time

Job summary

Orion Innovation is seeking a CSV Contractor to lead validation activities for GxP electronic systems within the manufacturing and clinical environments. You will collaborate with Business Owners, Technical Owners, and Quality to document and manage CSV deliverables across the validation lifecycle, ensuring compliance with 21 CFR Part 11 and related regulations.

The role emphasizes independent work, strong problem-solving, and effective communication across technical and non-technical

Qualifications

• Experience with cGMP, GXP, GAMP and SDLC; 21 CFR part 11 familiarity.
• Strong CSV documentation development: plans, requirements, specs, tests.
• Knowledge of MES validation and relevant regulatory guidelines.
• Ability to work with cross-functional teams and documentation systems.

Responsibilities

• Author, review and/or approve CSV documentation.
• Assist during test execution, document failures, ensure alignment with procedures.
• Assist in developing requirements and specifications for computerized systems in GxP operations.
• Other related duties as assigned.

Skills

Communication

Teamwork

Regulatory knowledge

Pharma systems

ITSM (ServiceNow)

Veeva

Problem solving

CSV knowledge

MES/ERP knowledge

Education

Bachelor's degree in life sciences or engineering/IT

Job description

Orion Innovation is a premier, award-winning, global business and technology services firm. Orion delivers game-changing business transformation and product development rooted in digital strategy, experience design, and engineering, with a unique combination of agility, scale, and maturity. We work with a wide range of clients across many industries including financial services, professional services, telecommunications and media, consumer products, automotive, industrial automation, professional sports and entertainment, life sciences, ecommerce, and education.

Purpose And Scope Of Position

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 BMS procedures and regulations.

Duties And 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 COMPETENCIES: Knowledge, Skills, and Abilities:

• 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).

Education And Experience

• 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.)

Orion is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, citizenship status, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

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