Job positions availables
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1. Validations Engineer/ Validations Specialist
Description:
Provide Technical expertise in the Qualification/ Validation of Equipment in a Regulated Manufacturing Environment. Writes/ creates validation protocols (IQ, OQ, PQ), and reports. Develop Validation studies on Equipment and processes. Understand and follow company procedures and regulatory requirements. Experience with process changes and investigations.
Requirements:
Bachelor degree in Engineering, Sciences or related field with proven 5+ years of experience in process Validation of solid products. Validation/ qualification of equipment developing IQ,OQ,PQ protocols/ reports in a regulated manufacturing environment. Excellent technical writing and interpersonal skills. Problem solving, troubleshooting. GMP/ GDP. Bilingual.
2. Quality Engineer
Description:
Quality Engineering duties in a FDA regulated Industries preferably in Medical Devices under GMP, GDP environment. Experience with documentation review, process changes, product release, CAPA, Quality Audits, annual product review, project implementation, and related activities. Develops and implements methods and procedures.
Requirements:
Bachelor degree in Engineering with proven 3+ years of experience in this field with similar responsibilities as in the description mention above. Previous experience in Medical Devices or Pharmaceutical Industries. Excellent Interpersonal Skills. Fully Bilingual Spanish and English. GMP/GDP environment, responsible, self-starter.
3. CSV Engineer
Description:
Commissioning, IQ, OQ. Support Leadership and compliance activities that include but are not limited to: SOP revisions, documentation review and approval (including change control, assessment plans, user requirements system, traceability matrix, user acceptance testing protocol, summary reports, design specification, and related activities. Responsible for ensuring that regulated computerized and automation systems are in full compliance w/ company procedures.
Requirements:
Bachelor degree in Engineering with 3+ years of proven experience in CSV development life cycle Validation and experience with description above. Troubleshooting, problem solving. Responsible and self-starter.
4. Validation Specialist (LCMS-Lab equip qualification)
Description:
Responsible for the Validation of new equipment “Liquid Chromatogram Mass Spectrometer (LCMS)” transferred from US to start all Qualification (IQ, OQ, PQ) and documentation in an Analytical laboratory in a Regulated manufacturing industry under GMP, GDP.
Requirements:
Bachelor degree in Chemistry or related Sciences with proven 2+ years of experience in laboratory equipment qualification in a regulated manufacturing industry, specifically with experience in the validation of a LCMS. Validation/ qualification of equipment developing IQ,OQ,PQ protocols/ reports. Excellent technical writing and interpersonal skills. Problem solving, troubleshooting. GMP/ GDP. Bilingual.
5. Metrology Technician
Description:
Work with calibrations, fixtures, tools, instrumentation. Work with measurements to compare with drawings.
Requirements:
Certified technician with experience working with general fixtures used in the regulated manufacturing industries (metrology). Experience with similar responsibilities as described above, specifically with experience in the calibrations department working with a variety of fixtures, tools, drawings, measurements, instrumentation. GMP, GDP. Excellent interpersonal skills, responsible, self-starter. Bilingual.
6. Validation Engineer (Product Transfer)
Description:
Work with validations of manufacturing equipment and product/process transfer in a Medical Devices Industry. Writes/ creates validation protocols (IQ, OQ, PQ), write reports. Understand and follow company procedures and regulatory requirements. Prepare validation protocols, work with process changes and product transfer.
Requirements:
Bachelor degree in Engineering with 3+ years of experience working with similar responsibilities as description above in a FDA regulated industry under a GMP, GDP environment. Experience in equipment qualification activities (IQ, OQ, PQ) and product/process transfer. Excellent technical writing and interpersonal skills. Problem solving, troubleshooting. Bilingual.
7. Process Validation Engineer
Description:
Provide Technical expertise in the Qualification/ Validation of Equipment in the Medical Devices industry. Writes/ creates validation protocols (IQ, OQ, PQ), and reports. Knowledge on machine automation. Work with verification of documentation generated from validations, documentation review, process changes, product release, Change controls, CAPA, project implementation, and related activities. Understand and follow company procedures and regulatory requirements.
Requirements:
Bachelor degree in Engineering with proven 2+ years of experience working with similar responsibilities as description above in a FDA regulated industry under a GMP, GDP environment. Experience in equipment qualification (IQ, OQ, PQ) and quality activities. Excellent technical writing and interpersonal skills. Problem solving, troubleshooting. Bilingual.
8. Cleaning Validation Specialist
Description:
Work with Cleaning Validation activities (Manufacturing) in the FDA regulated industries.
Requirements:
Bachelor degree in Sciences or related field. Experience working in the regulated manufacturing industries with all activities regarding Cleaning Validation, reports, documentation. Responsible.
