JT727 - VALIDATION SPECIALIST presso Quality Consulting Group
Quality Consulting Group · Villalba, Stati Uniti d'America · Onsite
- Professional
- Ufficio in Villalba
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:
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.
- 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
