Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering, to define cleaning validation requirements and processes. Develop and implement protocols for ...
Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering, to define cleaning validation requirements and processes. Develop and implement protocols for ...
PR · On-site
Perform risk assessments to support cleaning validation strategies ... Collaborate with Quality, Manufacturing, Engineering, Validation, and Microbiology teams. * Analyze ...
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PR · On-site
Perform risk assessments to support cleaning validation strategies ... Collaborate with Quality, Manufacturing, Engineering, Validation, and Microbiology teams. * Analyze ...
Bachelor's Degree in Engineering, Chemistry, Microbiology, or related Science field. * 3-7+ years of experience in cleaning validation within pharmaceutical or regulated manufacturing environments.
Bachelor's Degree in Engineering, Chemistry, Microbiology, or related Science field. * 3-7+ years of experience in cleaning validation within pharmaceutical or regulated manufacturing environments.
PR · On-site
Perform risk assessments to support cleaning validation strategies ... Collaborate with Quality, Manufacturing, Engineering, Validation, and Microbiology teams. * Analyze ...
Quick apply
PR · On-site
Perform risk assessments to support cleaning validation strategies ... Collaborate with Quality, Manufacturing, Engineering, Validation, and Microbiology teams. * Analyze ...
PR · On-site
Perform risk assessments to support cleaning validation strategies ... Collaborate with Quality, Manufacturing, Engineering, Validation, and Microbiology teams. * Analyze ...
Quick apply
PR · On-site
Perform risk assessments to support cleaning validation strategies ... Collaborate with Quality, Manufacturing, Engineering, Validation, and Microbiology teams. * Analyze ...
PR · On-site
Perform risk assessments to support cleaning validation strategies ... Collaborate with Quality, Manufacturing, Engineering, Validation, and Microbiology teams. * Analyze ...
Quick apply
PR · On-site
Perform risk assessments to support cleaning validation strategies ... Collaborate with Quality, Manufacturing, Engineering, Validation, and Microbiology teams. * Analyze ...
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... This role ensures that cleaning and sterilization systems are installed, tested, and qualified in ...
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... This role ensures that cleaning and sterilization systems are installed, tested, and qualified in ...
Validation Analyst
Anasco, PR · On-site
$30 - $31/hr
Education and/or experience: * BS in Engineering, preferably Computer, Mechanical, Industrial ... Experience in validations such as: manufacturing equipment, laboratory equipment, cleaning, test ...
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Validation Analyst
Anasco, PR · On-site
$30 - $31/hr
Education and/or experience: * BS in Engineering, preferably Computer, Mechanical, Industrial ... Experience in validations such as: manufacturing equipment, laboratory equipment, cleaning, test ...
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... The role spans the facility built-environment disciplines - facilities, utilities (clean + black ...
New
Quick apply
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... The role spans the facility built-environment disciplines - facilities, utilities (clean + black ...
New
PR · On-site
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... cleaning issues, validation issues, electrical issues and process maintenance issues. * Provide ...
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PR · On-site
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... cleaning issues, validation issues, electrical issues and process maintenance issues. * Provide ...
C&Q Specialist
Punta Santiago, PR · On-site
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... systems, clean utilities, facilities, cleanroom environments, process improvements, utilities ...
C&Q Specialist
Punta Santiago, PR · On-site
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... systems, clean utilities, facilities, cleanroom environments, process improvements, utilities ...
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... systems, clean utilities, facilities, cleanroom environments, process improvements, utilities ...
Quick apply
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... systems, clean utilities, facilities, cleanroom environments, process improvements, utilities ...
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... systems, clean utilities, facilities, cleanroom environments, process improvements, utilities ...
Quick apply
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... systems, clean utilities, facilities, cleanroom environments, process improvements, utilities ...
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... systems, clean utilities, facilities, cleanroom environments, process improvements, utilities ...
Quick apply
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... systems, clean utilities, facilities, cleanroom environments, process improvements, utilities ...
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... systems, clean utilities, facilities, cleanroom environments, process improvements, utilities ...
Quick apply
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... systems, clean utilities, facilities, cleanroom environments, process improvements, utilities ...
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... systems, clean utilities, facilities, cleanroom environments, process improvements, utilities ...
Quick apply
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... systems, clean utilities, facilities, cleanroom environments, process improvements, utilities ...
$20.25 - $28/hr
... engineering issues, regulatory issues, compliance issues, calibration issues, quality issues, microbial/environmental issues, technical cleaning issues, validation issues, electrical issues and ...
Quick apply
$20.25 - $28/hr
... engineering issues, regulatory issues, compliance issues, calibration issues, quality issues, microbial/environmental issues, technical cleaning issues, validation issues, electrical issues and ...
Sr. Quality Engineer
Juncos, PR · On-site
$86K - $117K/yr
For engineering services in the Manufacturing area. WHAT MAKES YOU A FIT: The Technical Part ... validation, cleaning validation, and cleanroom qualification activities in GMP-regulated ...
Sr. Quality Engineer
Juncos, PR · On-site
$86K - $117K/yr
For engineering services in the Manufacturing area. WHAT MAKES YOU A FIT: The Technical Part ... validation, cleaning validation, and cleanroom qualification activities in GMP-regulated ...
Sr. Manufacturing Engineer
Juncos, PR · On-site
$89K - $121K/yr
For Engineering services in the Manufacturing area. WHAT MAKES YOU A FIT: The Technical Part ... Strong experience with equipment qualification (IQ/CSV/OQ/PQ), process validation, cleaning ...
Sr. Manufacturing Engineer
Juncos, PR · On-site
$89K - $121K/yr
For Engineering services in the Manufacturing area. WHAT MAKES YOU A FIT: The Technical Part ... Strong experience with equipment qualification (IQ/CSV/OQ/PQ), process validation, cleaning ...
JT563 - SR QUALITY ENGINEER
Juncos, PR · On-site
$86K - $117K/yr
Collaborates with engineering and manufacturing functions to ensure quality standards are in place ... validation, cleaning validation, and cleanroom qualification activities in GMP-regulated ...
JT563 - SR QUALITY ENGINEER
Juncos, PR · On-site
$86K - $117K/yr
Collaborates with engineering and manufacturing functions to ensure quality standards are in place ... validation, cleaning validation, and cleanroom qualification activities in GMP-regulated ...
Cleaning Validation Engineer information
What is a cleaning validation engineer?
A Cleaning Validation Engineer ensures that manufacturing equipment and processes meet regulatory standards for cleanliness in industries like pharmaceuticals, biotech, and medical devices. They develop validation protocols, conduct tests, analyze data, and document results to confirm that cleaning procedures effectively remove contaminants. This role involves collaborating with quality assurance, production, and regulatory teams to maintain compliance with FDA, GMP, and other industry regulations.
What are the main challenges faced by cleaning validation engineers in the pharmaceutical industry?
Cleaning Validation Engineers in the pharmaceutical industry often face challenges such as staying up-to-date with evolving regulatory requirements, troubleshooting complex cleaning failures, and thoroughly documenting all validation activities. Balancing the needs for robust contamination control with operational efficiency requires analytical thinking and strong problem-solving abilities. Collaboration with manufacturing, quality assurance, and laboratory teams is frequent, as cleaning validation projects require input and support from multiple departments. Successfully managing these challenges ensures product safety, regulatory compliance, and continuous process improvement within manufacturing operations.
What are the key skills and qualifications needed to thrive as a cleaning validation engineer, and why are they important?
To thrive as a Cleaning Validation Engineer, you need a strong background in chemical engineering, microbiology, or a related field, often complemented by experience in GMP-regulated industries. Familiarity with validation protocols, analytical testing methods, and documentation tools (such as LIMS or QMS software) is essential, and certifications like Six Sigma or ASQ may be advantageous. Strong attention to detail, analytical thinking, and effective communication are key soft skills for success in the role. These capabilities are crucial to ensure regulatory compliance, product safety, and effective cross-functional collaboration in pharmaceutical or biotech manufacturing environments.
What are popular job titles related to Cleaning Validation Engineer jobs in Puerto Rico?
For Cleaning Validation Engineer jobs in Puerto Rico, the most frequently searched job titles are:
What job categories do people searching Cleaning Validation Engineer jobs in Puerto Rico look for?
The top searched job categories for Cleaning Validation Engineer jobs in Puerto Rico are:
Contractor
Re-posted 2 days ago
Job description
Job Summary:
The Cleaning Validation Specialist will be responsible for developing, executing, and managing cleaning validation activities to ensure compliance with regulatory requirements and internal quality standards. The role focuses on ensuring the effectiveness and consistency of cleaning processes, particularly for manufacturing equipment and related systems, including utilities and compressed air systems. The ideal candidate will bring expertise in cleaning validation, utilities qualification, and a strong understanding of GMP regulations.
Responsibilities:
Develop and implement cleaning validation protocols and reports, ensuring compliance with GMP, FDA, and other regulatory standards.
Plan and execute cleaning validation activities for manufacturing equipment and utilities, including compressed air systems.
Conduct risk assessments and identify critical control points for cleaning validation.
Perform sampling and testing of cleaned equipment and utilities to ensure compliance with predetermined acceptance criteria.
Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering, to define cleaning validation requirements and processes.
Develop and implement protocols for utilities qualification and monitoring, with a focus on compressed air systems.
Analyze data to identify trends and recommend process improvements to enhance cleaning and utilities validation performance.
Manage deviations and non-conformances related to cleaning validation activities, ensuring timely investigation and resolution.
Maintain detailed and accurate documentation of cleaning validation and utilities qualification activities.
Ensure the consistent implementation of cleaning validation processes across manufacturing operations.
Support audits and inspections by regulatory authorities, providing expertise in cleaning validation and utilities processes.
Stay current with industry trends and regulatory updates, ensuring continuous compliance and the adoption of best practices.
Qualifications:
Bachelor's Degree in Engineering, Chemistry, Microbiology, or a related field.
2+ years of experience in cleaning validation within a regulated manufacturing environment.
Experience in utilities qualification, particularly compressed air systems.
Strong knowledge of regulatory requirements, including GMP, FDA, and ICH guidelines.
Proficiency in developing and executing cleaning validation protocols and reports.
Demonstrated experience in risk assessment and data analysis for cleaning validation.
Excellent problem-solving and analytical skills.
Strong communication and interpersonal skills to collaborate with cross-functional teams and external auditors.
Proficiency in software tools such as MS Excel, Word, PowerPoint, and project management tools.
Physical/Mental Requirements:
Ability to work in a manufacturing environment, including cleanrooms and production areas.
Able to stand for extended periods and climb ladders/steps as needed.
Ability to lift and move items up to 25 lbs.
About the Company:
We consider all applicants for all positions regardless of race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or any other characteristic protected by law. We value diversity and promote an inclusive environment where all employees can thrive.