Validation Specialist

Hace 2 días

Juncos, Puerto Rico Novotech Engineering Corp. Jornada completa

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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:
* Flexible schedule

Shift availability:
* Day Shift (Preferred)

Work Location: Hybrid remote in Juncos, PR *

Validation Specialist

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