VALIDATION SPECIALIST

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

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 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.Qualifications:

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

Investigation and root cause analysis skills

Technical writing knowledge

Organization and Communication skills

Process Validation and Computer software validation knowledge

Experience in SDLC

Experience in medical devices or other highly regulated industry (e.g., medical devices, pharmaceuticals, biotech)

Excellent verbal and written communication skills in both English and Spanish

Availability to work 1st shift