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Última actualización: hace 7 días
Validation Specialist

Validation Specialist

HR WorksJayuya, Puerto Rico
The Cleaning Validation Specialist will be responsible for developing, executing, and managing cleaning validation activities to ensure compliance with regulatory requirements and internal quality ...Mostrar másÚltima actualización: hace más de 30 días
Housekeeper Wanted - Experienced Housekeeper Needed In Jayuya, Puerto Rico $50 / Hr

Housekeeper Wanted - Experienced Housekeeper Needed In Jayuya, Puerto Rico $50 / Hr

Housekeeper.comJayuya, Puerto Rico, USA
Looking for a reliable housekeeper in Jayuya, Puerto Rico.I need someone to help me with bathroom cleaning, shampooing the carpet, doing dishes, and tidying up the general rooms.It's essential ...Mostrar másÚltima actualización: hace más de 30 días
Border Patrol Agent - Experienced (GS11)

Border Patrol Agent - Experienced (GS11)

United States Customs and Border ProtectionAltos De Jayuya, PR, US
Border Patrol Agent - Experienced (GS11) Check out this higher-salaried federal law enforcement opportunity with U.Your current or prior law enforcement experience may qualify you for this career o...Mostrar másÚltima actualización: hace 8 días
Customs and Border Protection Officer

Customs and Border Protection Officer

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Customs and Border Protection (CBP) offers those interested in a career in law enforcement an exceptional opportunity to work with an elite team of highly trained professionals whose camaraderie, p...Mostrar másÚltima actualización: hace 21 días
Project Leader

Project Leader

RCM Technologies, Inc.Jayuya, PR
Jayuya, Puerto Rico, % on-site.Our client specializes in the manufacturing of medical serums and bags and is currently performing several process manufacturing improvements through the area.The Pro...Mostrar másÚltima actualización: hace 19 días
JT786 - ASSEMBLER I

JT786 - ASSEMBLER I

Quality Consulting GroupJayuya, PR
Quick Apply
QUALITY CONSULTING GROUP, es una compañía líder en la industria farmacéutica, biotecnológica, de dispositivos médicos y fabricación.Con una experiencia combi...Mostrar másÚltima actualización: hace 27 días
Associate Director Engineering

Associate Director Engineering

BaxterJayuya, Jayuya
This is where you save and sustain lives.At Baxter, we are deeply connected by our mission.No matter your role at Baxter, your work makes a positive impact on people around the world.You’ll feel a ...Mostrar másÚltima actualización: hace 7 días
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Validation Specialist

Validation Specialist

HR WorksJayuya, Puerto Rico
Hace más de 30 días
Descripción del trabajo

Job Summary :

The Cleaning Validation Specialist will be responsible for developing, executing, and managing cleaning validation activities to ensure compliance with regulatory requirements and internal quality standards. The role focuses on ensuring the effectiveness and consistency of cleaning processes, particularly for manufacturing equipment and related systems, including utilities and compressed air systems. The ideal candidate will bring expertise in cleaning validation, utilities qualification, and a strong understanding of GMP regulations.

Responsibilities :

  • Develop and implement cleaning validation protocols and reports, ensuring compliance with GMP, FDA, and other regulatory standards.
  • Plan and execute cleaning validation activities for manufacturing equipment and utilities, including compressed air systems.
  • Conduct risk assessments and identify critical control points for cleaning validation.
  • Perform sampling and testing of cleaned equipment and utilities to ensure compliance with predetermined acceptance criteria.
  • Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering, to define cleaning validation requirements and processes.
  • Develop and implement protocols for utilities qualification and monitoring, with a focus on compressed air systems.
  • Analyze data to identify trends and recommend process improvements to enhance cleaning and utilities validation performance.
  • Manage deviations and non-conformances related to cleaning validation activities, ensuring timely investigation and resolution.
  • Maintain detailed and accurate documentation of cleaning validation and utilities qualification activities.
  • Ensure the consistent implementation of cleaning validation processes across manufacturing operations.
  • Support audits and inspections by regulatory authorities, providing expertise in cleaning validation and utilities processes.
  • Stay current with industry trends and regulatory updates, ensuring continuous compliance and the adoption of best practices.

Qualifications :

  • Bachelor's Degree in Engineering, Chemistry, Microbiology, or a related field.
  • 2+ years of experience in cleaning validation within a regulated manufacturing environment.
  • Experience in utilities qualification, particularly compressed air systems.
  • Strong knowledge of regulatory requirements, including GMP, FDA, and ICH guidelines.
  • Proficiency in developing and executing cleaning validation protocols and reports.
  • Demonstrated experience in risk assessment and data analysis for cleaning validation.
  • Excellent problem-solving and analytical skills.
  • Strong communication and interpersonal skills to collaborate with cross-functional teams and external auditors.
  • Proficiency in software tools such as MS Excel, Word, PowerPoint, and project management tools.
  • Physical / Mental Requirements :

  • Ability to work in a manufacturing environment, including cleanrooms and production areas.
  • Able to stand for extended periods and climb ladders / steps as needed.
  • Ability to lift and move items up to 25 lbs.
  • About the Company :

    We consider all applicants for all positions regardless of race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or any other characteristic protected by law. We value diversity and promote an inclusive environment where all employees can thrive.