Empleos en 00681, pr, us
Última actualización: hace 16 horas
Validation Engineer
PharmEng Technology Americas00610, PR, US PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997.
Our specialists hold expertise in Commissioning and Qualificati...Mostrar másÚltima actualización: hace más de 30 días
Mantenimiento Hospital Bellavista
ABMMayaguez, PR,US The Cleaner provides the cleaning and upkeep of an assigned area.ABM offers a comprehensive benefits package.For information about ABM’s benefits, visit | (Programa de Beneficios de ABM).Must be 18...Mostrar másÚltima actualización: hace 15 días
Physical Therapist
CORA Physical TherapyRincon, PR, United States Physical Therapist - Full-Time.Get your career - and your patients - moving.Join the revolution of innovation and passion as a full-time Physical Therapist at CORA.
Our industry-leading programs and...Mostrar másÚltima actualización: hace más de 30 días
Sandwich Artist
Subway - 20703-000660, PR, US As part of the Subway® Team, you as a Sandwich Artist ® will focus on four main things : .Providing an excellent Guest experience.
Preparing and serving great food .Keeping restaurants cl...Mostrar másÚltima actualización: hace más de 30 días
Sandwich Artist
Subway - 29713-000660, PR, US As part of the Subway® Team, you as a Sandwich Artist ® will focus on four main things : .Providing an excellent Guest experience.
Preparing and serving great food .Keeping restaurants cl...Mostrar másÚltima actualización: hace más de 30 días
Store Associate - Northlake Village, Charlotte, NC
JD Group00636 Northlake Village At JD Finish Line, we’re not just selling products; we’re creating experiences.Our retail stores are a vibrant reflection of our brand’s passion for innovation and customer service.We’re on the loo...Mostrar másÚltima actualización: hace más de 30 días
Campus Ambassador
The Princeton ReviewMayaguez, PR, USA As The Princeton Review’s Campus Ambassador, you will be the vital link between your school campus and our local office.Campus Ambassadors are essential to our ability to forge new relationships an...Mostrar másÚltima actualización: hace 20 días
- Nueva oferta
EssilorLuxottica is hiring : Optometrist - Mayaguez, PR - LensCrafters in Mayague
EssilorLuxotticaMayaguez, PR, United States At LensCrafters, we love eyes and care about the people behind them.With over 900 locations, LensCrafters is the largest optical retailer in North America and our love of eyes and higher standard o...Mostrar másÚltima actualización: hace 16 horas
- Oferta promocionada
Online Survey Participant : Work Remote and Earn Up To $25 Per Survey
Earn HausMayaguez, PR, United States Looking for people to participate in taking online surveys for Fortune 500 brands.All you need to do is complete online surveys by sharing your opinion.
You will help influence brand decisions on se...Mostrar másÚltima actualización: hace más de 30 días
Tcnico de Procesos
Avanti MFG00680, PR, US Avanti est buscando tcnicos de procesospara unirse a nuestra empresa en crecimiento!.Nuestra empresa est localizada en Clarksville, Tennessee, USA.
No hay vacantes en Puerto Rico.Las vacantes estn u...Mostrar másÚltima actualización: hace más de 30 días
Retail Sales Associate (Part-Time)
AutoZoneMayaguez, Puerto Rico, United States AutoZone's Part-Time Retail Sales Associates drive sales through superior customer service by exceeding customer expectations and providing a WOW! Customer Service experience.While assisting custom...Mostrar másÚltima actualización: hace más de 30 días
Air Interdiction Agent
Customs and Border ProtectionHormigueros, Puerto Rico, US Pilot—CBP Air Interdiction Agent Air and Marine Operations (AMO), a component of U.Customs and Border Protection (CBP), offers skilled Pilots interested in law enforcement an opportunity to work wi...Mostrar másÚltima actualización: hace 4 días
Subway - 30591-0 is hiring : Sandwich Artist in 00677
Subway - 30591-000677, PR, United States As part of the Subway® Team, you as a Sandwich Artist ® will focus on four main things : .Providing an excellent Guest experience.
Preparing and serving great food .Keeping restaurants clean and beaut...Mostrar másÚltima actualización: hace 26 días
Esta oferta de trabajo no está disponible en tu país.
Validation Engineer
PharmEng Technology Americas00610, PR, USHace más de 30 días
Descripción del trabajoDevelop and execute equipment qualification protocols for all manufacturing, processing, and packaging equipment and facilities / utilities supporting these operations. Develop and execute process validation protocols for all manufacturing and packaging processes of commercial products (and R&D products as applicable). Develop and execute validation / verification protocols for all commercial and R&D manufacturing, processing, and packaging equipment. Analyze data, utilizing statistical methods, generated by validation studies performed by the Validation group to determine process capabilities. Gather photocopies and compile relevant documentation such as executed batch records, certificates of analysis, equipment logs, equipment qualifications, raw material certificates of analysis. Investigate and resolve deviations / exceptions from the predefined acceptance criteria. Draw conclusions from data, observations, deviation / exception, and investigation as to whether the process is considered valid. Write summary reports (closeout report when applicable) for validation / qualification protocols following criteria as outlined within the validation / qualification procedures and policies. Maintain protocols and system documentation in an orderly library so that information can be provided to regulatory bodies in a timely manner. Ensure protocols, verifications, validation plans, and summary reports generated during validation / qualification activities are stored according to the procedure. Maintain current knowledge in the areas of compliance and validation and other regulatory issues that may impact the Company. Work proactively to maintain the highest level of compliance in all areas. Gather current knowledge from QA / QC, regulatory, periodicals, and / or appropriate training programs. Interact and coordinate compliance efforts with other departments including, but not limited to, Operations, Engineering, QA, laboratories (QC and R&D), and R&D to provide a high degree of assurance that all qualification / validation activities, where appropriate, are completed. Adhere to all cGMPs, compliance / regulatory mandates and quality requirements. Perform other related duties as assigned to meet departmental and Company objectives.
Job Description
Job Description
PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning and Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products.
Job required Qualification :
- Bachelor of Science degree, Engineering, or Equivalent training and experience.
- More than 5 years of experience in a regulated environment.
- 3 years of experience authorizing procedural and commercial marketing documents.
- More than 3 years of experience with clean rooms, aseptic suites, single-use technology, bioreactors, and cell culture.
- Experience in mechanic and Industrial engineering
- Strong working knowledge of pharmaceutical industry regulations (GMP, GDP, ICH, etc.)
- Strong understanding and working knowledge of project lifecycle, entrepreneurial mindset, and excellent written and verbal communication skills.
- Strong relationship management, leadership, and organizational skills.
- Strong working knowledge in Microsoft suites, and Smartsheet.
Job responsibilities and Duties :