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Validation Engineer III (Medical Industry)
Bepc Inc. - Business Excellence Professional Consulting
Validate medical devices and systems ensuring GMP compliance and documentation.
9d ago
Intermediate (4-7 years), Junior (1-3 years)
Full Time
Ciudad Juárez, Chihuahua, Mexico
Onsite
Company Size
290 Employees
Service Specialisms
Technical Engineering Consulting
IT Project Management
Process Validation
Product Validation
Equipment Validation
Software Validation
Process Transfers
Product Transfers
Sector Specialisms
Life Science
Technology
Information Technology
Engineering
Manufacturing
Cleanroom Automation
Packaging Engineering
Process Automation
Role
What you would be doing
validation support
protocol writing
experiment execution
calibration records
gmp compliance
data reporting
- Provide technical engineering support for validations, write and execute Operational Qualification (OQ) protocols, and provide data to write completion reports for assigned validations.
- Responsible for running experiments during the pre-validation phase, run other experiments as needed.
- Provide technical engineering support for validations, write and execute Computer Systems Validation (CSV) protocols.
- Ensure that assigned validation activities are performed in a timely manner and in accordance with current requirements and Good Manufacturing Practices (GMP).
- Responsible for the execution of validation, including the creation of forms to create calibration and preventive maintenance records.
- Provide technical engineering support for validations, write and execute Total Maintenance Validation (TMV) protocols.
- Provide technical engineering support for validations, write and execute Installation Qualification (IQ) protocols, and provide data to write completion reports for assigned validations.
What you bring
six sigma
gmp
statistics
engineering degree
medical experience
intermediate english
- Intermediate English level (reading and writing) with intermediate conversation skills.
- Good presentation skills before groups/clients.
- 3 – 4 years of experience in medical industry
- Intermediate knowledge in Six Sigma, DMAIC and Kaizen.
- Demonstrate sufficient knowledge in validation skills, GMP, Good Documentation Practices (GDP).
- Engineering Degree (master’s in science is a plus)
- Intermediate knowledge in statistics.
Information not given or found
Training + DevelopmentInformation not given or found
Interview process
Information not given or found
Visa SponsorshipInformation not given or found
Security clearanceInformation not given or found
Company
Overview
100th Rank
Industry Recognition
Recognized as one of the top 100 inner-city businesses by the ICIC.
Silver Rating
Sustainability Excellence
Achieved a Silver rating from EcoVadis for outstanding sustainability practices.
$20M Revenue
Annual Financial Performance
Generates an estimated $20 million in annual revenue through high-impact project delivery.
2005 Founded
Establishment Year
Founded in 2005 to help Fortune 500 clients navigate technical and operational complexity.
- Evolving from a technical consulting boutique, it expanded into IT project management and global talent services across borders.
- Typical engagements include cleanroom commissioning, software and equipment validation, SAP deployment, and process automation.
- Specializing in life sciences, high-tech manufacturing, automotive, IT systems, and construction sectors.
- Operates a Mexico division catering to automotive and medical device clients, delivering engineering, validation, and automation services worldwide.
- Known for seamless integration of Lean/Six Sigma methodologies with technical consulting to optimize client operations.
- Commitment to excellence in every project
- Fostering a collaborative work environment
- Embracing innovation and continuous improvement
- Focus on delivering sustainable results for clients
- Integrity and accountability in all business practices
- Customer-centric approach to solutions
Net Zero by 2030
Sustainability Target
Committed to reducing greenhouse gas emissions to achieve net-zero status by 2030.
- Implementing eco-friendly technologies and processes in service delivery
- Promoting sustainability through responsible business practices
- Engagement with clients to help them meet sustainability goals
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