Sr. Engineer
Juncos, PR · On-site
$101K - $139K/yr
Participate in risk assessments (FMEA) and validation strategy development. Provide technical ... Basic Qualifications Bachelor's Degree in Mechanical, Electrical, Industrial, or Chemical ...
Sr. Engineer
Juncos, PR · On-site
$101K - $139K/yr
Participate in risk assessments (FMEA) and validation strategy development. Provide technical ... Basic Qualifications Bachelor's Degree in Mechanical, Electrical, Industrial, or Chemical ...
Perform risk assessments and identify critical quality attributes (CQAs) and critical process ... Bachelor's degree in Biochemical Engineering, Chemical Engineering, Biotechnology, or related field
Perform risk assessments and identify critical quality attributes (CQAs) and critical process ... Bachelor's degree in Biochemical Engineering, Chemical Engineering, Biotechnology, or related field
Support risk assessments and reliability improvement initiatives. Communication & Documentation ... Bachelor's Degree in Mechanical Engineering, Chemical Engineering, or related engineering ...
Support risk assessments and reliability improvement initiatives. Communication & Documentation ... Bachelor's Degree in Mechanical Engineering, Chemical Engineering, or related engineering ...
PR · On-site
... chemical management, spill response, and emergency preparedness activities. • Perform routine EHS inspections and risk assessments. EHS Documentation & Program Development (Start-Up Focus) • ...
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PR · On-site
... chemical management, spill response, and emergency preparedness activities. • Perform routine EHS inspections and risk assessments. EHS Documentation & Program Development (Start-Up Focus) • ...
... Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance ... risk assessments (not necessary lead the execution). * Coordinate verification for the Project ...
Quick apply
... Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance ... risk assessments (not necessary lead the execution). * Coordinate verification for the Project ...
... Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance ... risk assessments (not necessary lead the execution). * Coordinate verification for the Project ...
Quick apply
... Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance ... risk assessments (not necessary lead the execution). * Coordinate verification for the Project ...
PR · On-site
... Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance ... risk assessments (not necessary lead the execution). * Coordinate verification for the Project ...
Quick apply
PR · On-site
... Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance ... risk assessments (not necessary lead the execution). * Coordinate verification for the Project ...
PR · On-site
... Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance ... risk assessments (not necessary lead the execution). * Coordinate verification for the Project ...
Quick apply
PR · On-site
... Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance ... risk assessments (not necessary lead the execution). * Coordinate verification for the Project ...
PR · On-site
... Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance ... risk assessments (not necessary lead the execution). * Coordinate verification for the Project ...
Quick apply
PR · On-site
... Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance ... risk assessments (not necessary lead the execution). * Coordinate verification for the Project ...
PR · On-site
... Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance ... risk assessments (not necessary lead the execution). * Coordinate verification for the Project ...
Quick apply
PR · On-site
... Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance ... risk assessments (not necessary lead the execution). * Coordinate verification for the Project ...
PR · On-site
... Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance ... risk assessments (not necessary lead the execution). * Coordinate verification for the Project ...
Quick apply
PR · On-site
... Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance ... risk assessments (not necessary lead the execution). * Coordinate verification for the Project ...
PR · On-site
... Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance ... risk assessments (not necessary lead the execution). * Coordinate verification for the Project ...
Quick apply
PR · On-site
... Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance ... risk assessments (not necessary lead the execution). * Coordinate verification for the Project ...
PR · On-site
... Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance ... risk assessments (not necessary lead the execution). * Coordinate verification for the Project ...
Quick apply
PR · On-site
... Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance ... risk assessments (not necessary lead the execution). * Coordinate verification for the Project ...
Conduct risk assessments (FMEA) and support continuous improvement initiatives. * Develop ... Bachelor's Degree in Mechanical Engineering, Chemical Engineering, or related engineering ...
Conduct risk assessments (FMEA) and support continuous improvement initiatives. * Develop ... Bachelor's Degree in Mechanical Engineering, Chemical Engineering, or related engineering ...
PR · On-site
Author, review, and execute technical documents including protocols, reports, risk assessments ... Bachelor's degree in Chemical Engineering, Biochemistry, Biotechnology, Pharmaceutical Sciences, or ...
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PR · On-site
Author, review, and execute technical documents including protocols, reports, risk assessments ... Bachelor's degree in Chemical Engineering, Biochemistry, Biotechnology, Pharmaceutical Sciences, or ...
PR · On-site
$59K - $60K/yr
... Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance ... Apply basic risk-based thinking to assess system status and identify potential issues. * Ensure ...
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PR · On-site
$59K - $60K/yr
... Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance ... Apply basic risk-based thinking to assess system status and identify potential issues. * Ensure ...
PR · On-site
$57K - $58K/yr
... Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance ... Apply basic risk-based thinking to assess system status and identify potential issues. * Ensure ...
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PR · On-site
$57K - $58K/yr
... Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance ... Apply basic risk-based thinking to assess system status and identify potential issues. * Ensure ...
Staff Engineer, Quality Design & Reliability Assurance
Anasco, PR · On-site
$109K - $149K/yr
Leads and conducts SWAT assessments in risk management to support continuous improvement across ... Systems, Chemical) 8 years of experience of working within a medical device or other regulated ...
Staff Engineer, Quality Design & Reliability Assurance
Anasco, PR · On-site
$109K - $149K/yr
Leads and conducts SWAT assessments in risk management to support continuous improvement across ... Systems, Chemical) 8 years of experience of working within a medical device or other regulated ...
Packaging Project Manager
Gurabo, PR · On-site
Its services include the assessment and validation of automation systems, network infrastructures ... Develop and maintain detailed project plans, schedules, resource plans, and risk mitigation ...
Packaging Project Manager
Gurabo, PR · On-site
Its services include the assessment and validation of automation systems, network infrastructures ... Develop and maintain detailed project plans, schedules, resource plans, and risk mitigation ...
Its services include the assessment and validation of automation systems, network infrastructures ... Develop and maintain detailed project plans, schedules, resource plans, and risk mitigation ...
Quick apply
Its services include the assessment and validation of automation systems, network infrastructures ... Develop and maintain detailed project plans, schedules, resource plans, and risk mitigation ...
Chemical Risk Assessment information
What is chemical risk assessment?
Chemical risk assessment is the process of evaluating the potential adverse health and environmental effects caused by exposure to chemicals. This involves identifying hazards, assessing how and where people or the environment may be exposed, determining the level of risk, and recommending ways to manage or mitigate those risks. Chemical risk assessment is crucial in regulatory decision-making, workplace safety, and environmental protection. Professionals in this field use scientific data, exposure models, and toxicological information to inform policy and safeguard public health.
What are some typical challenges faced by professionals in Chemical Risk Assessment roles, and how can they be addressed?
Professionals in Chemical Risk Assessment often encounter challenges such as interpreting complex toxicological data, keeping up with evolving regulatory requirements, and effectively communicating risks to both technical and non-technical stakeholders. Addressing these challenges involves continuous learning, close collaboration with regulatory experts and scientists, and developing strong communication skills to present findings clearly. Working in multidisciplinary teams also helps ensure that assessments are comprehensive and aligned with organizational and legal standards.
What are the key skills and qualifications needed to thrive as a Chemical Risk Assessor, and why are they important?
To thrive as a Chemical Risk Assessor, you need a solid background in chemistry, toxicology, and environmental science, typically supported by a relevant degree. Familiarity with risk assessment models, regulatory databases, and statistical analysis software such as EPA’s EPI Suite or OECD tools is essential. Strong analytical thinking, attention to detail, and effective communication skills are vital for interpreting data and conveying complex findings to stakeholders. These skills are crucial to ensure the accurate evaluation of chemical hazards and compliance with safety regulations, ultimately protecting public health and the environment.
What is the difference between Chemical Risk Assessment vs Chemical Safety Specialist?
| Aspect | Chemical Risk Assessment | Chemical Safety Specialist |
|---|---|---|
| Primary Focus | Evaluating chemical hazards and risks to health and environment | Implementing safety protocols and ensuring compliance in chemical handling |
| Required Credentials | Degree in chemistry, toxicology, or related field; risk assessment certifications | Similar credentials; safety certifications like OSHA or HAZWOPER |
| Work Environment | Laboratories, risk assessment teams, regulatory agencies | Industrial sites, manufacturing plants, safety departments |
| Industry Usage | Regulatory compliance, environmental agencies, consulting | Industrial companies, chemical plants, safety consulting |
While both roles involve chemical safety, Chemical Risk Assessment focuses on analyzing hazards and determining risks, whereas Chemical Safety Specialist emphasizes implementing safety measures and ensuring compliance in workplaces.
What cities in Puerto Rico are hiring for Chemical Risk Assessment jobs? Cities in Puerto Rico with the most Chemical Risk Assessment job openings:
$101K - $139K/yr
Other
Posted 8 days ago
Job description
mirus Consulting Group is a Puerto Rico based technical services firm headquartered in Humacao. The company specializes inComputer System Validation (CSV)andInformation Technology consultingfor thepharmaceutical and life sciences industriesacross Puerto Rico and parts of the United States. Its services include theassessment and validation of automation systems, network infrastructures, and business processes, as well as comprehensiveproject management supportto ensure compliance, efficiency, and operational excellence.
Position Overview
The Senior Engineer will provide technical leadership and hands-on engineering support for process validation and packaging systems characterization, with a strong emphasis on packaging operations. This role is critical to ensuring that packaging processes, equipment (including cartoners), and systems are fully characterized, validated, and compliant with GMP and regulatory requirements. The engineer will play a key role in Drug Product packaging operations, supporting process validation, equipment qualification, packaging characterization, and product transfer activities, while collaborating with cross-functional teams including Manufacturing, Quality, Automation, and Supply Chain.
Key Responsibilities
Validation & Engineering Activities
Lead and execute Commissioning, Qualification, and Validation (IQ/OQ/PQ / PPQ) for packaging and manufacturing equipment.
Develop and execute validation protocols and reports, ensuring full lifecycle compliance.
Perform and lead packaging process characterization studies, defining process capability, critical parameters, and operational ranges.
Support equipment qualification activities, including cartoners, labeling systems, and automated packaging systems.
Ensure validation strategies align with site validation master plans and regulatory expectations.
Packaging & Process Characterization (Critical Focus)
Provide technical expertise in packaging operations, including cartoning equipment, labeling, serialization, and inspection systems.
Lead packaging equipment characterization, including performance evaluation, efficiency, and process robustness.
Support troubleshooting and technical investigations related to packaging processes and equipment.
Evaluate and optimize packaging systems using data-driven and risk-based approaches (DOE, FMEA).
Support New Product Introduction (NPI) and technology transfer activities with strong focus on packaging readiness.
Cross-Functional Collaboration
Partner with Manufacturing, Quality, Automation, and Supply Chain teams to support execution and validation readiness.
Participate in risk assessments (FMEA) and validation strategy development.
Provide technical support during audits, inspections, and regulatory interactions.
Support training and knowledge transfer for new processes, equipment, and validated systems.
Additional Responsibilities
Support continuous improvement initiatives focused on packaging efficiency, yield, and reliability.
Analyze process performance data and recommend improvements to enhance operational performance.
Lead or support capital projects, equipment upgrades, and system improvements.
Basic Qualifications
Bachelor's Degree in Mechanical, Electrical, Industrial, or Chemical Engineering
Minimum 5+ years of experience in packaging engineering within regulated industries (pharma/biotech/medical devices)
Strong hands-on experience in process validation and packaging systems characterization
Preferred Qualifications
Proven experience with packaging equipment, especially cartoners (cartoneras)
Strong expertise in validation lifecycle (IQ/OQ/PQ/PPQ) and process characterization
Experience supporting technology transfer, NPI, and packaging line implementation
Knowledge of GMP, FDA regulations, and validation frameworks
Experience with automation systems, serialization, and vision inspection technologies
Strong technical writing and documentation skills
Key Technical Skills
Packaging Process Characterization
Validation Lifecycle (IQ/OQ/PQ / PPQ)
Cartoning Equipment (Cartoneras) & Packaging Systems
GMP / FDA Compliance
Change Control & Deviation Management
Root Cause Analysis & CAPA
Risk Management (FMEA)
Technical Documentation & Protocol Authoring
This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.
Position Overview
The Senior Engineer will provide technical leadership and hands-on engineering support for process validation and packaging systems characterization, with a strong emphasis on packaging operations. This role is critical to ensuring that packaging processes, equipment (including cartoners), and systems are fully characterized, validated, and compliant with GMP and regulatory requirements. The engineer will play a key role in Drug Product packaging operations, supporting process validation, equipment qualification, packaging characterization, and product transfer activities, while collaborating with cross-functional teams including Manufacturing, Quality, Automation, and Supply Chain.
Key Responsibilities
Validation & Engineering Activities
Lead and execute Commissioning, Qualification, and Validation (IQ/OQ/PQ / PPQ) for packaging and manufacturing equipment.
Develop and execute validation protocols and reports, ensuring full lifecycle compliance.
Perform and lead packaging process characterization studies, defining process capability, critical parameters, and operational ranges.
Support equipment qualification activities, including cartoners, labeling systems, and automated packaging systems.
Ensure validation strategies align with site validation master plans and regulatory expectations.
Packaging & Process Characterization (Critical Focus)
Provide technical expertise in packaging operations, including cartoning equipment, labeling, serialization, and inspection systems.
Lead packaging equipment characterization, including performance evaluation, efficiency, and process robustness.
Support troubleshooting and technical investigations related to packaging processes and equipment.
Evaluate and optimize packaging systems using data-driven and risk-based approaches (DOE, FMEA).
Support New Product Introduction (NPI) and technology transfer activities with strong focus on packaging readiness.
Cross-Functional Collaboration
Partner with Manufacturing, Quality, Automation, and Supply Chain teams to support execution and validation readiness.
Participate in risk assessments (FMEA) and validation strategy development.
Provide technical support during audits, inspections, and regulatory interactions.
Support training and knowledge transfer for new processes, equipment, and validated systems.
Additional Responsibilities
Support continuous improvement initiatives focused on packaging efficiency, yield, and reliability.
Analyze process performance data and recommend improvements to enhance operational performance.
Lead or support capital projects, equipment upgrades, and system improvements.
Basic Qualifications
Bachelor's Degree in Mechanical, Electrical, Industrial, or Chemical Engineering
Minimum 5+ years of experience in packaging engineering within regulated industries (pharma/biotech/medical devices)
Strong hands-on experience in process validation and packaging systems characterization
Preferred Qualifications
Proven experience with packaging equipment, especially cartoners (cartoneras)
Strong expertise in validation lifecycle (IQ/OQ/PQ/PPQ) and process characterization
Experience supporting technology transfer, NPI, and packaging line implementation
Knowledge of GMP, FDA regulations, and validation frameworks
Experience with automation systems, serialization, and vision inspection technologies
Strong technical writing and documentation skills
Key Technical Skills
Packaging Process Characterization
Validation Lifecycle (IQ/OQ/PQ / PPQ)
Cartoning Equipment (Cartoneras) & Packaging Systems
GMP / FDA Compliance
Change Control & Deviation Management
Root Cause Analysis & CAPA
Risk Management (FMEA)
Technical Documentation & Protocol Authoring
This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.