Novotech Corporation has stand out for its great performance with the clients having a strong exposure providing support to operational areas such as: Utilities, Procurement, Quality and Construction in Mechanical and HVAC systems. We consist in having qualified engineers with more than ten (10) years of experience providing:
- Delivery in HVAC systems for the most comprehensive lines of top performing air movement, control, and conditioning equipment’s.
- Certification and/or qualification for inspections in volume, smoke, and fire dampers for heating, ventilation and/or air conditioning systems
- Engineering Services Management in Manufacturing and Federal Industries with highly regulated procedures.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
- Validation Specialist to support qualification and validation activities for manufacturing equipment, utilities, computerized systems, and processes. The successful candidate will play a key role in ensuring compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, and Amgen quality standards while supporting the reliable operation of manufacturing and laboratory systems.
Key Responsibilities
- Plan, execute, and document qualification and validation activities, including:
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Process Validation
- Cleaning Validation (as applicable)
- Prepare, review, and approve validation protocols, reports, risk assessments, and related documentation.
- Coordinate validation activities with Engineering, Manufacturing, Quality Assurance, Quality Control, Automation, and other cross-functional teams.
- Support commissioning and qualification of new equipment, facilities, and utilities.
- Ensure validation documentation complies with cGMP, FDA, EMA, and other applicable regulatory requirements.
- Identify opportunities to improve validation processes, documentation, and overall operational efficiency.
Basic Qualifications
- Bachelor's degree in Engineering, Life Sciences, Biotechnology, Chemistry, or a related technical discipline.
- Minimum of 3 years of validation experience in the pharmaceutical, biotechnology, or medical device industry.
- Working knowledge of cGMP regulations and validation lifecycle principles.
- Experience preparing and executing validation protocols and reports.
- Strong technical writing and documentation skills.
- Excellent organizational, communication, and problem-solving abilities.
- Ability to work independently while collaborating effectively within cross-functional teams.
Preferred Qualifications
- Experience in biotechnology manufacturing or sterile manufacturing environments.
- Experience with computerized system validation (CSV) and data integrity principles.
Job Type: Full-time
Benefits:
Shift availability:
Work Location: Hybrid remote in Juncos, PR 00777
