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Cgi Group Inc Jobs overseas

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CSV Specialist - Laboratory at QRC Group, Inc
Manatí, Puerto Rico, United States - Full Time
Skills Needed
Computer Systems Validation, Laboratory Systems, Gmp, Data Integrity, System Lifecycle Management, Cmms Systems, Calibration Documentation, Electronic Data Archival, Change Controls, Technical Documentation, Preventive Maintenance, User Access Evaluations, Sops, Audit Trail Reviews, Ehs Compliance, Technical Drawings
Specialization
Candidates must have a bachelor's degree in Science or a related field and a minimum of 3 years of experience in CSV, QA, or laboratory systems within a regulated environment. A strong understanding of GMP and data integrity principles is essential.
Experience Required
Minimum 2 year(s)
Software Application Configuration at QRC Group, Inc
Cayey, Puerto Rico, United States - Full Time
Skills Needed
Software Configuration, Implementation, Technical Support, Electronic Batch Records, Programming, Scripting, Medical Device Standards, Regulatory Compliance
Specialization
Candidates must have a bachelor's degree in Computer Science or a related field and 3-5 years of experience in software configuration or implementation. Familiarity with medical device software standards and regulatory compliance is also required.
Experience Required
Minimum 2 year(s)
CSV Specialist-Laboratory at QRC Group, Inc
Manatí, Puerto Rico, United States - Full Time
Skills Needed
Computer Systems Validation, Laboratory Systems, Gmp, Data Integrity, System Lifecycle Management, Change Control, Calibration Documentation, Electronic Data Archival, Maximo, Technical Documentation, Preventive Maintenance, Sops, Audit Trail Reviews, User Access Evaluations, Ehs Compliance, Technical Drawings
Specialization
Candidates must have a Bachelor’s degree in Science or a related field and a minimum of 3 years of experience in CSV, QA, or laboratory systems within a regulated environment. A strong understanding of GMP, data integrity principles, and experience with CMMS systems is also required.
Experience Required
Minimum 2 year(s)
Vehicle Technician at Sinclair Group
Hay, , United Kingdom - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
CI/Process Specialist at QRC Group, Inc
Cayey, Puerto Rico, United States - Full Time
Skills Needed
Project Management, Process Technology, Cross Functional Collaboration, Lean Six Sigma, Engineering Support, Manufacturing, Safety, Quality, Delivery, Cost
Specialization
A Bachelor of Science in Engineering, preferably in Industrial Engineering, is required along with experience in the Medical Devices Industry. Candidates should have project management experience and knowledge of Lean Six Sigma methodologies.
Experience Required
Minimum 2 year(s)
Process Operator I at AptarGroup Inc
Midland, MI 48642, USA - Full Time
Skills Needed
Instructions, Manufacturing, Communication Skills, Ged, English, Product Lines
Qualification
Diploma
Vehicle Technician at Sinclair Group
Cardiff CF23 8RS, , United Kingdom - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Validation Support Specialist at QRC Group, Inc
Aibonito, Puerto Rico, United States - Full Time
Skills Needed
Technical Support, Process Validation, Product Validation, Documentation Preparation, Risk Assessment, Change Control, Continuous Improvement, Problem Solving, Statistical Techniques, Bilingual, Manufacturing Engineering, Quality Assurance, Standard Operating Procedures, Customer Complaint Evaluation, Ncr Investigations, Ehs Practices
Specialization
Candidates must have a Bachelor Degree in Science or Engineering and 1-2 years of experience in a regulated industry. Bilingual proficiency in English and Spanish is also required.
Validation Support Specialist at QRC Group, Inc
Aibonito, Puerto Rico, United States - Full Time
Skills Needed
Technical Support, Process Validation, Product Validation, Documentation Review, Risk Assessment, Change Control, Continuous Improvement, Problem Solving, Statistical Techniques, Bilingual, Manufacturing Engineering, Quality Assurance, Standard Operating Procedures, Customer Complaints, Ncr Investigations, Ehs Practices
Specialization
Candidates must have a Bachelor Degree in Science or Engineering and 1-2 years of experience in a regulated industry. They should possess collaborative skills, knowledge of problem-solving techniques, and be bilingual in English and Spanish.
Process Development Scientist at QRC Group, Inc
Juncos, Puerto Rico, United States - Full Time
Skills Needed
Process Development, Technical Support, Troubleshooting, Root Cause Analysis, Process Optimization, Characterization Protocols, Risk Assessments, Project Management, Documentation, Vision System Technologies, Packaging Concepts, Serialization Solutions, Material Requests, Training Coordination, Interdisciplinary Collaboration, Self Driven
Specialization
Candidates should possess strong technical documentation skills and be proficient in various documentation software. A doctorate or a master's degree with relevant experience is required.
Experience Required
Minimum 2 year(s)
Sr. Engineer at QRC Group, Inc
Juncos, Puerto Rico, United States - Full Time
Skills Needed
Process Support, Data Analysis, Continuous Improvement, Technical Support, Troubleshooting, Deviation Investigations, Process Monitoring, Cross Functional Collaboration, Technical Documentation, Gmp Regulations, Statistical Analysis, Sap, Trackwise, Problem Solving, Independent Work, Teamwork
Specialization
Candidates must have a Doctorate in Engineering or a related field, or a Master's/Bachelor's degree with relevant experience. Strong understanding of Drug Substance manufacturing processes and proficiency in relevant systems are required.
Experience Required
Minimum 2 year(s)
Validation Engineer at QRC Group, Inc
Atlanta, Georgia, United States - Full Time
Skills Needed
Iq/Oq/Pq Protocol Development, Fat/Sat Testing, Validation Master Plan Creation, Mes/Scada System Qualification, Injection Molding Validation, Automated Assembly Validation, Metrology Equipment Calibration, Gage R&R, Traceability Matrix Development, Kneat Software, Regulatory Knowledge, Fda 21 Cfr Part 820, Eu Mdr 2017/745, Iso 13485, Iso 14971, Gmp Compliance
Specialization
A Bachelor's degree in Engineering (Mechanical, Biomedical, Chemical, or Industrial) is required. Candidates should have experience with IQ/OQ/PQ protocol development, FAT/SAT testing, and regulatory knowledge including FDA and ISO standards.
Experience Required
Minimum 2 year(s)
Senior Quality Inspector (m/w/d) at AptarGroup Inc
44319 Dortmund, , Germany - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Senior Programmer / Developer at CMC Group, Inc
Bowling Green, Ohio, United States - Full Time
Skills Needed
Iot Integration, Api Onboarding, Cloud Management, Sql, C#, Asp.Net, Javascript, Html, Css, Data Mapping, Data Validation, Project Management, Software Development, Security Compliance, Problem Solving, Team Collaboration, Technical Documentation
Specialization
Candidates should have a Master's degree or 5+ years of experience in Computer Science or Software Engineering, with knowledge of relational databases and cloud environments. Proficiency in programming languages and web application development is also preferred.
Experience Required
Minimum 5 year(s)
Commis d'entrepôt, Division Uniformes corporatifs at Groupe JSV Inc
Montréal, QC H1E 5Y8, Canada - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Director of Product Excellence at CMC Group, Inc
Bowling Green, Ohio, United States - Full Time
Skills Needed
Product Development, Product Management, Project Management, Market Research, Team Leadership, Communication Skills, Cross Functional Collaboration, Customer Needs Assessment, Sales Training, Product Launch, Product Improvement, Training Development, Problem Resolution, Competitive Analysis, Servant Leadership, Technical Support
Specialization
Candidates should have a Bachelor's degree and 5-10 years of experience in product development or management. Strong project management skills and the ability to influence cross-functional teams are essential.
Experience Required
Minimum 5 year(s)
Validation Engineer at QRC Group, Inc
Caguas, Puerto Rico, United States - Full Time
Skills Needed
Iq/Oq/Pq Protocol Development, Fat/Sat Testing, Validation Master Plan Creation, Mes/Scada System Qualification, Injection Molding Validation, Automated Assembly Validation, Metrology Equipment Calibration, Gage R&R, Traceability Matrix Development, Kneat Software, Fda 21 Cfr Part 820, Eu Mdr 2017/745, Iso 13485, Iso 14971, Gmp Compliance, Six Sigma
Specialization
Candidates must have a Bachelor's degree in Engineering, preferably in Mechanical, Biomedical, Chemical, or Industrial fields. Technical skills in IQ/OQ/PQ protocol development and regulatory knowledge are essential.
Experience Required
Minimum 2 year(s)
Process Development Scientist at QRC Group, Inc
Juncos, Puerto Rico, United States - Full Time
Skills Needed
Protein Science, Formulation, Filling Processes, Process Monitoring, Statistical Tools, Technology Transfer, Process Validation, Deviations Support, Product Impact Assessments, Floor Support, Microsoft Office, Jmp, Minitab, Communication Skills, Problem Solving Skills, Project Management Skills
Specialization
Candidates should have a Doctorate or Master's degree with 2 years of scientific experience, or a Bachelor's degree with 4 years of scientific experience in Life Sciences or Engineering. Bilingual proficiency in Spanish and English is required, along with strong communication and problem-solving skills.
Experience Required
Minimum 2 year(s)
Quality Analyst (m/w/d) at AptarGroup Inc
44319 Dortmund, , Germany - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Validation Specialist at QRC Group, Inc
Aibonito, Puerto Rico, United States - Full Time
Skills Needed
Validation, Process Validation, Equipment Validation, Technical Writing, Computer Literacy
Specialization
Candidates must have a bachelor's degree in sciences and five years of experience in a related field. Bilingual proficiency in Spanish and English is required, along with technical writing and computer literacy skills.
Experience Required
Minimum 5 year(s)
CSV Specialist - Laboratory at QRC Group, Inc
Manatí, Puerto Rico, United States -
Full Time

Start Date

Immediate

Expiry Date

15 Jan, 26

Salary

0.0

Posted On

18 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Computer Systems Validation, Laboratory Systems, GMP, Data Integrity, System Lifecycle Management, CMMS Systems, Calibration Documentation, Electronic Data Archival, Change Controls, Technical Documentation, Preventive Maintenance, User Access Evaluations, SOPs, Audit Trail Reviews, EHS Compliance, Technical Drawings

Industry

Staffing and Recruiting

Description
Company Description 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 http://www.qrcgroup.com/ to learn more about our services and solutions! Job Description The CSV Specialist - Laboratory to lead and execute computer systems validation activities associated with the decommissioning of laboratory equipment, instruments, and systems. This role ensures compliance with regulatory requirements and internal standards during retirement, archival, and documentation of assets and data within a GMP-regulated environment. Responsibilities Decommissioning Execution Generate and manage Change Controls related to laboratory decommissioning. Prepare and execute CSV Decommissioning Packages for equipment, instruments, and computerized systems. Coordinate final calibration and cleaning documentation for decommissioned assets. Manage CMMS retirement/inactivation documentation and update/deactivate assets in Maximo (equipment, instruments, computer systems). Review and archive preventive maintenance job plans, calibration records, and spare parts inventories. Collect and archive equipment/instrumentation manuals and technical documentation. Prepare and submit Finance Decommissioning documentation. Data Integrity & System Controls Perform system periodic assessment verification, audit trail reviews, and user access evaluations. Coordinate backup and archival of electronic data in compliance with data integrity standards. Review and update or retire SOPs, forms, and validation documents. Evaluate open records including Data Integrity Assessments, investigations, CAPAs, Infinity records, change controls, and change actions. Verify and remove hardware components as part of system retirement. Compliance & Documentation Coordinate closure of EHS-related change actions. Update and archive technical drawings associated with decommissioned assets. Compile and deliver turnover packages for final QA review. Ensure proper closure of change controls and documentation handoff. Qualifications Bachelor’s degree in Science or related field. Minimum 3 years of experience in CSV, QA, or laboratory systems within a regulated environment. Strong understanding of GMP, data integrity principles, and system lifecycle management. Experience with CMMS systems (e.g., Maximo), calibration documentation, and electronic data archival. Fluent in English and Spanish (spoken and written). Additional Information All your information will be kept confidential according to EEO guidelines.
Responsibilities
The CSV Specialist - Laboratory will lead and execute computer systems validation activities related to the decommissioning of laboratory equipment and systems. This role ensures compliance with regulatory requirements during the retirement and documentation of assets and data in a GMP-regulated environment.
CSV Specialist - Laboratory at QRC Group, Inc
Manatí, Puerto Rico, United States - Full Time
Skills Needed
Computer Systems Validation, Laboratory Systems, Gmp, Data Integrity, System Lifecycle Management, Cmms Systems, Calibration Documentation, Electronic Data Archival, Change Controls, Technical Documentation, Preventive Maintenance, User Access Evaluations, Sops, Audit Trail Reviews, Ehs Compliance, Technical Drawings
Specialization
Candidates must have a bachelor's degree in Science or a related field and a minimum of 3 years of experience in CSV, QA, or laboratory systems within a regulated environment. A strong understanding of GMP and data integrity principles is essential.
Experience Required
Minimum 2 year(s)
Software Application Configuration at QRC Group, Inc
Cayey, Puerto Rico, United States - Full Time
Skills Needed
Software Configuration, Implementation, Technical Support, Electronic Batch Records, Programming, Scripting, Medical Device Standards, Regulatory Compliance
Specialization
Candidates must have a bachelor's degree in Computer Science or a related field and 3-5 years of experience in software configuration or implementation. Familiarity with medical device software standards and regulatory compliance is also required.
Experience Required
Minimum 2 year(s)
CSV Specialist-Laboratory at QRC Group, Inc
Manatí, Puerto Rico, United States - Full Time
Skills Needed
Computer Systems Validation, Laboratory Systems, Gmp, Data Integrity, System Lifecycle Management, Change Control, Calibration Documentation, Electronic Data Archival, Maximo, Technical Documentation, Preventive Maintenance, Sops, Audit Trail Reviews, User Access Evaluations, Ehs Compliance, Technical Drawings
Specialization
Candidates must have a Bachelor’s degree in Science or a related field and a minimum of 3 years of experience in CSV, QA, or laboratory systems within a regulated environment. A strong understanding of GMP, data integrity principles, and experience with CMMS systems is also required.
Experience Required
Minimum 2 year(s)
Vehicle Technician at Sinclair Group
Hay, , United Kingdom - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
CI/Process Specialist at QRC Group, Inc
Cayey, Puerto Rico, United States - Full Time
Skills Needed
Project Management, Process Technology, Cross Functional Collaboration, Lean Six Sigma, Engineering Support, Manufacturing, Safety, Quality, Delivery, Cost
Specialization
A Bachelor of Science in Engineering, preferably in Industrial Engineering, is required along with experience in the Medical Devices Industry. Candidates should have project management experience and knowledge of Lean Six Sigma methodologies.
Experience Required
Minimum 2 year(s)
Process Operator I at AptarGroup Inc
Midland, MI 48642, USA - Full Time
Skills Needed
Instructions, Manufacturing, Communication Skills, Ged, English, Product Lines
Qualification
Diploma
Vehicle Technician at Sinclair Group
Cardiff CF23 8RS, , United Kingdom - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Validation Support Specialist at QRC Group, Inc
Aibonito, Puerto Rico, United States - Full Time
Skills Needed
Technical Support, Process Validation, Product Validation, Documentation Preparation, Risk Assessment, Change Control, Continuous Improvement, Problem Solving, Statistical Techniques, Bilingual, Manufacturing Engineering, Quality Assurance, Standard Operating Procedures, Customer Complaint Evaluation, Ncr Investigations, Ehs Practices
Specialization
Candidates must have a Bachelor Degree in Science or Engineering and 1-2 years of experience in a regulated industry. Bilingual proficiency in English and Spanish is also required.
Validation Support Specialist at QRC Group, Inc
Aibonito, Puerto Rico, United States - Full Time
Skills Needed
Technical Support, Process Validation, Product Validation, Documentation Review, Risk Assessment, Change Control, Continuous Improvement, Problem Solving, Statistical Techniques, Bilingual, Manufacturing Engineering, Quality Assurance, Standard Operating Procedures, Customer Complaints, Ncr Investigations, Ehs Practices
Specialization
Candidates must have a Bachelor Degree in Science or Engineering and 1-2 years of experience in a regulated industry. They should possess collaborative skills, knowledge of problem-solving techniques, and be bilingual in English and Spanish.
Process Development Scientist at QRC Group, Inc
Juncos, Puerto Rico, United States - Full Time
Skills Needed
Process Development, Technical Support, Troubleshooting, Root Cause Analysis, Process Optimization, Characterization Protocols, Risk Assessments, Project Management, Documentation, Vision System Technologies, Packaging Concepts, Serialization Solutions, Material Requests, Training Coordination, Interdisciplinary Collaboration, Self Driven
Specialization
Candidates should possess strong technical documentation skills and be proficient in various documentation software. A doctorate or a master's degree with relevant experience is required.
Experience Required
Minimum 2 year(s)
Sr. Engineer at QRC Group, Inc
Juncos, Puerto Rico, United States - Full Time
Skills Needed
Process Support, Data Analysis, Continuous Improvement, Technical Support, Troubleshooting, Deviation Investigations, Process Monitoring, Cross Functional Collaboration, Technical Documentation, Gmp Regulations, Statistical Analysis, Sap, Trackwise, Problem Solving, Independent Work, Teamwork
Specialization
Candidates must have a Doctorate in Engineering or a related field, or a Master's/Bachelor's degree with relevant experience. Strong understanding of Drug Substance manufacturing processes and proficiency in relevant systems are required.
Experience Required
Minimum 2 year(s)
Validation Engineer at QRC Group, Inc
Atlanta, Georgia, United States - Full Time
Skills Needed
Iq/Oq/Pq Protocol Development, Fat/Sat Testing, Validation Master Plan Creation, Mes/Scada System Qualification, Injection Molding Validation, Automated Assembly Validation, Metrology Equipment Calibration, Gage R&R, Traceability Matrix Development, Kneat Software, Regulatory Knowledge, Fda 21 Cfr Part 820, Eu Mdr 2017/745, Iso 13485, Iso 14971, Gmp Compliance
Specialization
A Bachelor's degree in Engineering (Mechanical, Biomedical, Chemical, or Industrial) is required. Candidates should have experience with IQ/OQ/PQ protocol development, FAT/SAT testing, and regulatory knowledge including FDA and ISO standards.
Experience Required
Minimum 2 year(s)
Senior Quality Inspector (m/w/d) at AptarGroup Inc
44319 Dortmund, , Germany - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Senior Programmer / Developer at CMC Group, Inc
Bowling Green, Ohio, United States - Full Time
Skills Needed
Iot Integration, Api Onboarding, Cloud Management, Sql, C#, Asp.Net, Javascript, Html, Css, Data Mapping, Data Validation, Project Management, Software Development, Security Compliance, Problem Solving, Team Collaboration, Technical Documentation
Specialization
Candidates should have a Master's degree or 5+ years of experience in Computer Science or Software Engineering, with knowledge of relational databases and cloud environments. Proficiency in programming languages and web application development is also preferred.
Experience Required
Minimum 5 year(s)
Commis d'entrepôt, Division Uniformes corporatifs at Groupe JSV Inc
Montréal, QC H1E 5Y8, Canada - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Director of Product Excellence at CMC Group, Inc
Bowling Green, Ohio, United States - Full Time
Skills Needed
Product Development, Product Management, Project Management, Market Research, Team Leadership, Communication Skills, Cross Functional Collaboration, Customer Needs Assessment, Sales Training, Product Launch, Product Improvement, Training Development, Problem Resolution, Competitive Analysis, Servant Leadership, Technical Support
Specialization
Candidates should have a Bachelor's degree and 5-10 years of experience in product development or management. Strong project management skills and the ability to influence cross-functional teams are essential.
Experience Required
Minimum 5 year(s)
Validation Engineer at QRC Group, Inc
Caguas, Puerto Rico, United States - Full Time
Skills Needed
Iq/Oq/Pq Protocol Development, Fat/Sat Testing, Validation Master Plan Creation, Mes/Scada System Qualification, Injection Molding Validation, Automated Assembly Validation, Metrology Equipment Calibration, Gage R&R, Traceability Matrix Development, Kneat Software, Fda 21 Cfr Part 820, Eu Mdr 2017/745, Iso 13485, Iso 14971, Gmp Compliance, Six Sigma
Specialization
Candidates must have a Bachelor's degree in Engineering, preferably in Mechanical, Biomedical, Chemical, or Industrial fields. Technical skills in IQ/OQ/PQ protocol development and regulatory knowledge are essential.
Experience Required
Minimum 2 year(s)
Process Development Scientist at QRC Group, Inc
Juncos, Puerto Rico, United States - Full Time
Skills Needed
Protein Science, Formulation, Filling Processes, Process Monitoring, Statistical Tools, Technology Transfer, Process Validation, Deviations Support, Product Impact Assessments, Floor Support, Microsoft Office, Jmp, Minitab, Communication Skills, Problem Solving Skills, Project Management Skills
Specialization
Candidates should have a Doctorate or Master's degree with 2 years of scientific experience, or a Bachelor's degree with 4 years of scientific experience in Life Sciences or Engineering. Bilingual proficiency in Spanish and English is required, along with strong communication and problem-solving skills.
Experience Required
Minimum 2 year(s)
Quality Analyst (m/w/d) at AptarGroup Inc
44319 Dortmund, , Germany - Full Time
Skills Needed
Good Communication Skills
Qualification
Graduate
Validation Specialist at QRC Group, Inc
Aibonito, Puerto Rico, United States - Full Time
Skills Needed
Validation, Process Validation, Equipment Validation, Technical Writing, Computer Literacy
Specialization
Candidates must have a bachelor's degree in sciences and five years of experience in a related field. Bilingual proficiency in Spanish and English is required, along with technical writing and computer literacy skills.
Experience Required
Minimum 5 year(s)