Computer System Validation Engineer Pharma (Hybrid- Bothell, WA)
We are seeking a Computer System Validation Engineer Pharma for a global pharmaceutical client. You will work cross-functionally to lead and execute validation activities for GxP electronic systems and applications. 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 primary responsibility to ensure that the tasks supporting validation of Manufacturing Execution Systems (MES) are documented in accordance with the relevant procedures and regulations
This is a 40-hour per-week, 6-month contract (extensions possible), 3 days per week onsite role in Bothell, WA and required to be onsite throughout UAT execution.
This is a W2 role as a Stage 4 Solutions employee. Health benefits and a 401K are offered.
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
Requirements:
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. Familiarity with MES systems (i.e. Emerson Syncade), ERP systems (i.e. SAP or Oracle) and EBRs (i.e. InfoBatch).
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.)
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).
Bachelor's degree in a life sciences or engineering / IT discipline or equivalent industry experience.
Please submit your resume to our network at (please apply to the Computer System Validation Engineer Pharma (Hybrid- Bothell, WA) role).
Please feel free to forward this project opening to others who may be interested.
Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates' qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.
Compensation: $70/hr. - $76.61/hr.
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