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Senior Validation Engineer
hace 3 semanas
BEPC Inc. provides specialized engineering solutions and IT project management services to Fortune 500 companies within the life sciences and technology industries. BEPC Mexico, a division of BEPC Incorporated, delivers and manages consulting services for automotive and medical device companies throughout Mexico and worldwide.
BEPC has an
open position in the Ciudad Juárez area
for a
Senior Validation Engineer
to join our fast-growing team of consultants.
Key Responsibilities
- Provide technical engineering support for validation activities, including writing and executing Installation Qualification (IQ) protocols, and supplying data for validation completion reports.
- Write and execute Operational Qualification (OQ) protocols and provide supporting data for completion reports.
- Write and execute Performance Qualification (PQ) protocols and provide supporting data for completion reports.
- Develop and execute Computer System Validation (CSV) protocols.
- Develop and execute Total Maintenance Validation (TMV) protocols.
- Write and execute SAT (Site/Factory Acceptance Testing) validation protocols and provide data for completion reports.
- Conduct experiments during the pre-validation phase and perform additional experiments as required.
- Ensure all assigned validation activities are completed on time and in compliance with current requirements and Good Manufacturing Practices (GMP).
- Demonstrate strong knowledge of validation processes, GMP, and Good Documentation Practices (GDP).
- Execute validation activities, including the creation of calibration and preventive maintenance documentation and records.
Required Qualifications
- Bachelor's degree in Engineering (Master of Science preferred).
- 4–6 years of experience in the manufacturing industry and/or 5–6 years of experience in the medical device industry.
- Strong presentation skills when working with teams and clients.
- Solid experience developing factorial experiments (Design of Experiments – DOE).
- Extensive knowledge of Lean methodologies.
- Intermediate knowledge of Six Sigma, DMAIC, and Kaizen.
- Intermediate knowledge of Project Management principles.
- Strong background in statistics.
