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Engineering Spec
Villaba, Puerto Rico · Biotech/PharmaceuticalJOB DESCRIPTION
We are seeking a Validation Specialist to support the evaluation, qualification, and documentation of computerized systems and manufacturing processes. This role is ideal for a detail-oriented professional with experience in FDA-regulated environments and strong bilingual communication skills.
Key Responsibilities
Evaluate the impact of validated computerized systems on existing work instructions and processes
Prepare and execute computer system validation protocols and generate comprehensive reports
Develop and maintain Installation Qualification (IQ) documentation
Collaborate with process owners to implement changes to work instructions and ensure compliance
Inspect machinery, equipment, and tools to verify performance and initiate corrective actions as needed
Ensure adherence to company procedures, quality system regulations, and industry standards
Apply technical expertise and knowledge of Client's engineering practices to optimize equipment and manufacturing techniques
Organize and track project progress, maintaining detailed documentation and status updates
Contribute to cross-functional projects and support milestone completion
Communicate effectively with internal stakeholders to share updates, gather input, and support decision-making
Candidate Profile
This role is suited for individual contributors with professional expertise. Candidates should be capable of working independently on moderately complex projects and mentoring junior team members when needed.
Top 3 Qualifications We’re Looking For
Hands-on experience in Process and Computerized Systems Validation
Background in FDA-regulated industries (e.g., medical devices, pharmaceuticals, biotech)
Excellent verbal and written communication skills in both English and Spanish
Education & Experience Requirements
Bachelor’s degree in Engineering.
Minimum of 3 years of relevant experience, or an advanced degree with 0 years of experience
Practical knowledge and demonstrated competence in validation and quality systems
**Weil Group is proud to be an Equal Employment Opportunity Employer.**
We are seeking a Validation Specialist to support the evaluation, qualification, and documentation of computerized systems and manufacturing processes. This role is ideal for a detail-oriented professional with experience in FDA-regulated environments and strong bilingual communication skills.
Key Responsibilities
Evaluate the impact of validated computerized systems on existing work instructions and processes
Prepare and execute computer system validation protocols and generate comprehensive reports
Develop and maintain Installation Qualification (IQ) documentation
Collaborate with process owners to implement changes to work instructions and ensure compliance
Inspect machinery, equipment, and tools to verify performance and initiate corrective actions as needed
Ensure adherence to company procedures, quality system regulations, and industry standards
Apply technical expertise and knowledge of Client's engineering practices to optimize equipment and manufacturing techniques
Organize and track project progress, maintaining detailed documentation and status updates
Contribute to cross-functional projects and support milestone completion
Communicate effectively with internal stakeholders to share updates, gather input, and support decision-making
Candidate Profile
This role is suited for individual contributors with professional expertise. Candidates should be capable of working independently on moderately complex projects and mentoring junior team members when needed.
Top 3 Qualifications We’re Looking For
Hands-on experience in Process and Computerized Systems Validation
Background in FDA-regulated industries (e.g., medical devices, pharmaceuticals, biotech)
Excellent verbal and written communication skills in both English and Spanish
Education & Experience Requirements
Bachelor’s degree in Engineering.
Minimum of 3 years of relevant experience, or an advanced degree with 0 years of experience
Practical knowledge and demonstrated competence in validation and quality systems
**Weil Group is proud to be an Equal Employment Opportunity Employer.**