Staff Validation Engineer: GMP, DOE & Lean Six Sigma Lead

BEPC Inc. - Business Excellence Professional Consulting; Ciudad Juárez; On-site; MXN 540,000 - 900,000; Full time

Job summary

BEPC Inc. seeks a Staff Validation Engineer in Mexico to lead end-to-end validation strategies for process, equipment, computer systems and maintenance.

You will drive DOE development, Lean Six Sigma initiatives and project-level execution while collaborating with Operations, Design and Engineering teams to ensure products meet GMP, regulatory and design requirements. Responsibilities include IQ/OQ/PQ/CSV/TMV validation protocols, SAT testing, pre-validation experiments, and maintaining

Qualifications

• Solid skills in developing Factorial Experiments (DOE).
• Strong knowledge in Lean Six Sigma, DMAIC and Kaizen.
• Good presentation skills before groups/clients.

Responsibilities

• Provide validation support, write and execute IQ protocols and contribute data for completion reports.
• Provide validation support, write and execute OQ protocols and contribute data for completion reports.
• Provide validation support, write and execute PQ protocols and contribute data for completion reports.
• Provide validation support for CSV protocols.
• Provide validation support for TMV protocols.
• Provide validation support for SAT validation protocols and contribute data for completion reports.
• Run experiments during the pre-validation phase and as needed.
• Ensure validation activities comply with GMP and documentation practices (GDP).
• Create forms for calibration and preventive maintenance records.
• Support development of production of new products.
• Analyze and help develop manufacturing functions, capabilities and facilities.
• Collaborate with Operations and Design teams to verify and validate regulatory and design requirements.

Skills

Factorial Experiments (DOE)

Lean Six Sigma

Presentation skills

Education

Engineering degree

Job description

BEPC Inc. seeks a Staff Validation Engineer in Mexico to lead end-to-end validation strategies for process, equipment, computer systems and maintenance.

You will drive DOE development, Lean Six Sigma initiatives and project-level execution while collaborating with Operations, Design and Engineering teams to ensure products meet GMP, regulatory and design requirements. Responsibilities include IQ/OQ/PQ/CSV/TMV validation protocols, SAT testing, pre-validation experiments, and maintaining