Responsibilities: We are seeking a skilled Validation Engineer with experience in GxP compliance and expertise in 21.... Requirements: Proven experience as a Validation Engineer in the life sciences industry. Strong understanding of GxP compliance...
processes, process validation, computer and equipment validation, and GMPs. Ability to develop clear, concise, and timely oral...: This position has responsibility and authority for:Development and approval of Validation Plans, IQ, OQ Protocols, Trace Matrices...
Experience with Test Method Validation and/or Measurement System Analysis is preferred. Knowledge of computer software for the... qualification (IQ/OQ/PQ). Development of test methods for Design V&V, Process Validation, and Production Validation of test...
analysis of any discrepancy reports generated during validation execution and proposing CAPA's. Requirements: Bachelor...'s degree in life sciences or engineering. 5+ years of validation experience in a cell and gene therapy GMP environment...
validation team and be responsible for the validation of automated equipment and control systems Create and modify validation... Revew Retirement Summary review Deliverables: Requirement document Validation/Test Plan Requirement Traceability Matrix...
, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies. Coordinate with multi-disciplinary validation team... and be responsible for the validation of automated equipment and control systems. Create and modify validation documentation including...
for CSV and Process Validations · Support the development of the qualification and validation programs at Just including the... transition from paper based to digital validation software to configure globally scalable end to end paperless solutions...
Effects Analysis (FMEA)) is preferred. Certification by ASQ (Certified Quality Auditor, Certified Quality Engineer...
Job Summary The IDCS Systems Engineer will be a highly skilled and motivated Linux System Engineer and Administrator..., and run testing for validation. This position is required to report to the SHI Piscataway NJ office location as determined...
manufacturing process. Reviews and approves batch records, validation protocols, data, and reports. Requirements: Demonstrated.... Engineer or Scientist, MSc or equivalent in a technical field (Chemistry, Pharmaceutics, Biological Sciences, Chemical...
, qualification, verification and validation of new and existing equipment and processes. Coordinate with vendors and suppliers...
and other relevant agencies. Support the facility team in maintaining equipment. Assist the validation team in conducting facility...
and other relevant agencies. Support the facility team in maintaining equipment. Assist the validation team in conducting facility...
and other relevant agencies. Support the facility team in maintaining equipment. Assist the validation team in conducting facility...
standards. Lead the creation and validation of test vehicles and methodologies for material characterization in targeted...
with process and equipment validation. AutoCAD and SolidWorks experience preferred....
. Oversee the calibration management program and coordinate with vendors to ensure timely execution. Validation Management...: Plan, track, and schedule validation activities. Approve and oversee validation protocols and coordinate scheduling...
that values its culture and people as its biggest strengths. Come join us as a Computer Systems Validation Consultant! Together..., business process knowledge, and consulting excellence. As a Computer Systems Validation (CSV) Consultant...
or consumer packaging. Knowledge and understanding of packaging design validation standards (ISO, ASTM, etc.), drafting...
QUALITY ANALYST: • A minimum of 4-6 years of related experience. Must have Process Validation experience. Good... of GMP/ISO regulations and validation regulations The ability to perform 'hands on' troubleshooting and problem solving...