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Sr. Engineer
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We are seeking a Sr. Engineer to develop and implement the overall Commissioning & Qualification strategy aligned with project and regulatory requirements. 1. Commissioning & Qualification Strategy and Planning: (e.g., ISPE Baseline, ASTM E2500) to determine qualification scope. 2. Commissioning Activities: FAT, SAT, and field commissioning. 3. Qualification Execution (IQ/OQ/PQ) Author, review, and approve qualification protocols (IQ, OQ, PQ). Ensure traceability from User Requirements Specifications (URS) through testing. 4. Documentation & Compliance: Ensure all C&Q documentation complies with GMP, FDA, EMA, and internal standards. Support data integrity and ALCOA+ principles throughout qualification activities. 5. Risk Management & Change Control Preventive actions (CAPA). 6. Cross-functional Coordination 7. Characterization Process

Requisitos:
 Requirements:
 Doctorate or, Masters + 2 years engineering experience or, Bachelor’s in engineering + 4 years of Engineering experience. Packaging Process experience. Bilingual (English and Spanish, written and spoken).



Requiere Mucha Experiencia Requires Expert

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Empleos en Puerto RicoJobs in Puerto Rico
QRC GROUP LLC

Empleos en Puerto RicoJobs in Puerto Rico Ingenieros
Juncos PR 00600 Juncos
DescripciónDescription We are seeking a Sr. Engineer to develop and implement the overall Commissioning & Qualification strategy aligned with project and regulatory requirements. 1. Commissioning & Qualification Strategy and Planning: (e.g., ISPE Baseline, ASTM E2500) to determine qualification scope. 2. Commissioning Activities: FAT, SAT, and field commissioning. 3. Qualification Execution (IQ/OQ/PQ) Author, review, and approve qualification protocols (IQ, OQ, PQ). Ensure traceability from User Requirements Specifications (URS) through testing. 4. Documentation & Compliance: Ensure all C&Q documentation complies with GMP, FDA, EMA, and internal standards. Support data integrity and ALCOA+ principles throughout qualification activities. 5. Risk Management & Change Control Preventive actions (CAPA). 6. Cross-functional Coordination 7. Characterization Process Requisitos Requirements Doctorate or, Masters + 2 years engineering experience or, Bachelor’s in engineering + 4 years of Engineering experience. Packaging Process experience. Bilingual (English and Spanish, written and spoken).

Requiere Mucha Experiencia Requires Expert
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Director de Ingeniería
Ingenieros (Ingenieros - Otros) Engineering (Engineers - Others)
Galeria


AVISO de ClasificadosOnline
Los patronos NO le piden dinero ni un depósito para trabajar, si lo piden es un negocio, inversión o Fraude.
NO envíe dinero para trabajar, tampoco ofrezca información personal, por teléfono o email. Evite el Fraude ClasificadosOnline Warning
Employers DON'T ask for money or deposits for work, if they do is a bussiness, invertion or Fraud.
DON'T send money for work, neither offer personal information, by phone or email. Avoid the Fraud

Empleos en Puerto RicoJobs in Puerto Rico
QRC GROUP LLC

Empleos en Puerto RicoJobs in Puerto Rico Ingenieros
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