Computer Systems Validation Engineer

Socket.dev; Olympia (WA); On-site; USD 110,000 - 170,000; Full time

Job summary

Orion Innovation is seeking a CSV Contractor to lead validation activities for MES and other GxP systems within a regulated manufacturing environment. You will create and manage validation deliverables across the lifecycle, ensuring adherence to 21 CFR Part 11 and GAMP guidelines.

The role requires strong communication with technical and non-technical stakeholders, collaboration with Quality, and the ability to work independently in a fast-paced, global setting.

Qualifications

• 4+ years of CSV experience with GAMP/risk-based validation.
• Strong knowledge of CSV documentation (plans, requirements, specs, IQ/OQ/PQ).
• Experience validating MES and electronic records/signatures.

Responsibilities

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

Skills

MES experience

GxP knowledge

Regulatory compliance

IT service management

Education

Bachelor's degree in life sciences or engineering

Tools

ServiceNow

Veeva

SAP/Oracle

InfoBatch

Emerson Syncade

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

Skills

MES experience Required

unicorn

Syncade.

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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