Validation Engineers
Jornada completa
QRC Group
We are seeking Validation Engineer professionals to support validation activities for sterile manufacturing, plant operations, facilities, equipment, systems, room requalification, and project-based validation initiatives. Assignment may include one or more active site projects, depending on project need. The role includes authoring and executing protocols, supporting field execution, documenting results, resolving discrepancies, and owning validation deliverables through closeout.
Project Assignment Areas
- Grade D Manufacturing Environment project, including Central Dust Extraction, Grade D area/suite qualification, and equipment relocation validations.
- Bulk IPA Storage systems validation.
- Fillers Relocation room requalification.
- Pledget Dust Remediation dust-extraction equipment validation.
- Plant operations and quality project validation scope.
- Facilities-related validations for designated engineers, including HVAC, utilities, and cleanroom.
Key Responsibilities
- Author and execute commissioning and qualification protocols and reports, including IQ/OQ/PQ.
- Own validation deliverables through execution, discrepancy resolution, and closeout.
- Execute field activities and document results in accordance with applicable validation requirements.
- Support equipment, systems, facilities, utilities, cleanroom, room requalification, and project validation activities as assigned.
- Perform risk-based assessments and support FMEA activities where applicable.
- Coordinate validation deliverables with QA, Engineering, and Manufacturing.
- Support multiple concurrent projects, depending on assignment.
Requirements
Required Qualifications
- Bachelor’s degree in Engineering or a related technical field.
- Minimum 5 years of validation experience in a regulated environment.
- Hands-on IQ/OQ/PQ authoring and execution experience.
- Experience supporting equipment, systems, facilities, utilities, cleanroom, and/or regulated manufacturing validation.
- Working knowledge of cGMP and 21 CFR 210/211.
- Strong technical-writing skills.
- Ability to work on-site in El Paso, Texas .
- Bilingual English/Spanish preferred.
Preferred Qualifications
- Sterile / combination drug-device manufacturing background.
- Experience with Kneat.
- ISO 14971 / FMEA experience.
- Cleanroom / ISO 14644 experience.
- Validation leadership experience, where applicable.
Vacante publicada el Hace un mes
Empleos similares que podrían interesarleBasado en la vacante Validation Engineers en Caguas
$35 - $37 por hora
...Description Job Description We are seeking a Senior Manufacturing Engineer for a temp-to-hire opportunity in Caguas, PR within the... ...documentation, including work instructions, process specifications, validation documentation, engineering change records, and process...SugeridoPor horaTemporalCASRemoto- ...For Manufacturing services in the Engineering area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor’s Degree and minimum... ...Manufacturing Engineering & Technical Project Management Process Validation, Qualification & Statistical Data Analysis Root Cause...SugeridoContratoTrabajo por turnos
- ...For quality services in the engineering area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor’s Degree in Engineering field... ...Capital Projects Cost Improvement Projects IQ/OQ/PQ validations or Product Transfers is preferred but not required. Quality...SugeridoContratoTrabajo por turnos
- ...The Senior Manufacturing Engineer will apply scientific knowledge, engineering knowledge, mathematics and ingenuity to lead moderately... ...supervision. Tasks: Runs studies and qualification/validations on the line as needed. Writes protocols and reports with no...SugeridoContrato
- ...Quality Engineer Experience Required: 10+ Years Education: Bachelor's Degree in Engineering Industry: Medical Devices... ...with a strong background in data analysis, statistical analysis, validation, and sampling methodologies within the medical device manufacturing...SugeridoTiempo completo
- ...provide a highly effective service. The Supplier Quality Engineer will support activities in a Medical Devices manufacturing environment... ...inspection area. Experience evaluating, selecting, validating and qualifying equipment / tools/ technologies for accurate inspection...ContratistaTiempo completo
- ...We are seeking a Process Engineer with pharma-medical device experience as well as validations life-cycle experience (write/execute/analyze/close) to support the daily operations: Root cause analysis Investigation experience for QN/CAPAclosures Experience...ContratoTrabajo por turnos
- ...Job Summary: Reporting to the Supervisor/Manager this position is responsible for coordinating and executing engineering activities. The role requires high technical aptitude and problem-solving ability, and excellent teamwork skills to be successful. Influences project...ContratistaTiempo completoTurno de noche
- ...Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields. Log on now to our website qrcgroup... ...data and results. Collaborate with Manufacturing, Engineering, Quality, and Validation teams to ensure project objectives are...Contrato
- ...the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience... ...teams to develop and maintain serialization and aggregation validation procedures and documentation. Develop, review, execute, and...Tiempo completoTrabajar en la oficina
- ...For Validation services in the Engineering area. FITS is looking for a Senior Engineer to support a leading pharmaceutical manufacturer. You’ll be the technical lead behind packaging equipment projects: designing new equipment processes, guiding them through validation...Trabajo por turnos
$38 000 - $42 000 por año
...construcción. Sucursales: coordinar transferencias de inventario entre almacén central y sucursales. Transportistas: cotizaciones, validación de facturas de flete y evaluación de desempeño. ERP: registro de recibos, transferencias, despachos y pruebas de entrega (POD...Tiempo completo- ...external customer service. Duties: Biweekly collect resources’ payroll documents, invoices and timesheets received. Validate hours in TSheets (Time and Attendance platform) and transfer their information to QuickBooks. Process each employee timesheets...Tiempo parcialTrabajar en la oficina
- ...CSV Engineer - Computerized Systems Validation | Medical Device Industry Company: Scientific Safety Alliance (SSA) Location: Puerto Rico Industry: Medical Device Manufacturing About the Opportunity Scientific Safety Alliance (SSA) is identifying qualified...Tiempo completo
- ...Validation Specialist with experience in regulated industry validating/qualifying laboratory equipment, manufacturing equipment, processes... ...(manufacturing and laboratory) Requirements Bachelor in Engineering or Sciences At least five years or experience with...Contrato
- ...~ Experience recruiting for regulated industries, including Pharmaceutical, Biotechnology, Medical Devices, Manufacturing, or Engineering environments. ~ Hands-on experience with an Applicant Tracking System (ATS) such as Zoho Recruit or similar platforms. ~ Experience...Contrato
- ...between quotes received to identify potential gaps and discrepancies REQUIREMENTS: Degree in Construction Management, Civil Engineering, Architecture, Engineering, or related field. Technical or associate degrees with relevant construction estimating experience...SubcontratistaTiempo completo
- ...QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields. Log on now to our website qrcgroup.com / to learn more about our services and solutions! Job Description...Contrato
- ...We are seeking an Sr. Engineer with experience in Medical Device or Pharma. Knowledge in: Packaging equipment. Design of new equipment process. Engineering Project Validations Requirements Education: Master’s degree or Bachelor’s degree in Engineering...Contrato
- ...the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience... ...wide variety of mechanical machines and devices including pumps, engines, motors, conveyors, compressors, and laboratory equipment by...Tiempo completoCAS
- ...Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields. Log on now to our website qrcgroup.... ...and solutions! Job Description We are seeking an Engineer p rovides engineering support for the operation, troubleshooting...ContratoTrabajo por turnosFin de semana
- ...Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields. Log on now to our website qrcgroup.... ...Description We are seeking an experienced Principal Engineer to provide technical and organizational leadership for Process...Contrato
- ...We are looking for a qualified Jr. Validation Specialist with knowledge and experience with aseptic and regulated processes and developing and executing: Validation protocols. Validation reports. SOPs (Standard Operating Procedures). Statistical data analysis...Contrato
- ...general supervision will evaluate, select and apply standard engineering techniques, basic principles and procedures. Function as a... ...development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for...ContratoTrabajo por turnos
- ...provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and...Tiempo completoCAS
- ...provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and...PrácticaCASTrabajar en la oficinaRemotoHorario flexible
- ...Job Summary: Leads the full engineering lifecycle—from system planning and asset engineering... ...and O&M investment decisions rest on validated engineering criteria and technical justification... ...Required: Professional Engineer License issued by the Examining Board for...Tiempo completo
- ...Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields. Log on now to our website qrcgroup.... ...solutions! Job Description We are seeking an Sr. Engineer with experience in Medical Device or Pharma. Knowledge in:...Contrato
- ...or capital projects environment. Applies advanced and diverse engineering principles to the design and implementation of major system... ...Manufacturing, Process Engineering, Maintenance, Quality, Automation, Validation, and equipment suppliers. Managing multiple concurrent...Tiempo completoTrabajo por turnos
- ...or capital projects environment. Applies advanced and diverse engineering principles to the design and implementation of major system... ...new equipment process. Knowledge in Engineering Project and Validation Lifecycle. Experience in Medical Device or Pharma...Tiempo completoTrabajo por turnos
¿Desea recibir más vacantes?
Suscríbase y reciba vacantes similares a Validation Engineers. ¡Sea el primero en aplicar!
