Computer System Validation Engineer

Local candidates to Bothell WA ONLY

MUST have Manufacturing Execution Systems (MES)

83861

TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence.

Our client, a leading pharmaceutical company is hiring a Computer System Validation Engineer for a 6+ months hybrid contracting assignment.

Must have skills:

Strong Computer Systems Validation (CSV) experience, Manufacturing Execution Systems (MES), Protocol drafting and execution

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 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:

$74-75/hour W2

Location:

Bothell WA Hybrid (3 days a week onsite) and required to be onsite throughout UAT execution

Responsibilities:

Works cross-functionally to lead and execute validation activities for GxP electronic systems and applications

Primary responsibility to ensure that the tasks supporting validation of Manufacturing Execution Systems (MES) are documented in accordance with 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

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)

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)