Computer System Validation Engineer

• 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.

• 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

• 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 a good understanding of electronic records and signatures
• Strong knowledge of Manufacturing Execution System (MES) validation.
• Strong knowledge of regulations, current industry practices, and experience with the application of guidelines and regulations related to the control of computerized systems, electronic records/signatures
• Strong knowledge of the development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ or equivalent], Summary Reports, Trace Matrices, SOPs, etc.)

The hourly rate for this position is between $73 - $75 per hour.

Compensation:
Factors which may affect starting pay within this range may include [geography/market, skills, education, experience, and other qualifications of the successful candidate].

Benefits:
Sunrise offers ACA-compliant medical coverage/dental insurance/vision insurance to all employees. We also offer Sick time benefits as required per State regulations.

Contact:
Sunny Rajput | sunny.r@sunrisesys.com | URL: www.sunrisesys.com