Compliance Engineer
Gurabo, PR · On-site
Revise and maintain controlled documents using systems such as TrackWise (TV) and Kneat. * Support document lifecycle management, ensuring accuracy, completeness, and compliance with GMP requirements.
New
Compliance Engineer
Gurabo, PR · On-site
Revise and maintain controlled documents using systems such as TrackWise (TV) and Kneat. * Support document lifecycle management, ensuring accuracy, completeness, and compliance with GMP requirements.
New
Kneat or other software) is a major asset but not required. * Capital Improvements experience is a major asset but not required. Key Responsibilities * Lead all CQV project activities for ...
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Kneat or other software) is a major asset but not required. * Capital Improvements experience is a major asset but not required. Key Responsibilities * Lead all CQV project activities for ...
Proficient with KNEAT execution * Design and develop cleaning procedures for new products and manufacturing equipment. * Investigates and conducts troubleshooting/root cause analysis of cleaning ...
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Proficient with KNEAT execution * Design and develop cleaning procedures for new products and manufacturing equipment. * Investigates and conducts troubleshooting/root cause analysis of cleaning ...
PR · On-site
$25 - $30/hr
Kneat Software experience required. * Availability and flexibility to work the 4PM-12AM night shift on an 8/7 rotating schedule. * Bilingual in English and Spanish (oral and written). Preferred
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PR · On-site
$25 - $30/hr
Kneat Software experience required. * Availability and flexibility to work the 4PM-12AM night shift on an 8/7 rotating schedule. * Bilingual in English and Spanish (oral and written). Preferred
Experience working within digital validation platforms such as Kneat is highly desirable. This position requires an individual who can work independently while collaborating cross-functionally with ...
Experience working within digital validation platforms such as Kneat is highly desirable. This position requires an individual who can work independently while collaborating cross-functionally with ...
Kneat or other software) is a major asset but not required. * Capital Improvements experience is a major asset but not required. Key Responsibilities * Lead all CQV project activities for ...
Kneat or other software) is a major asset but not required. * Capital Improvements experience is a major asset but not required. Key Responsibilities * Lead all CQV project activities for ...
Kneat or other software) is a major asset but not required. * Capital Improvements experience is a major asset but not required. Key Responsibilities * Lead all CQV project activities for ...
Kneat or other software) is a major asset but not required. * Capital Improvements experience is a major asset but not required. Key Responsibilities * Lead all CQV project activities for ...
Kneat or other software) is a major asset but not required. * Capital Improvements experience is a major asset but not required. Key Responsibilities * Lead all CQV project activities for ...
Quick apply
Kneat or other software) is a major asset but not required. * Capital Improvements experience is a major asset but not required. Key Responsibilities * Lead all CQV project activities for ...
Experience working within digital validation platforms such as Kneat is highly desirable. This position requires an individual who can work independently while collaborating cross-functionally with ...
Quick apply
Experience working within digital validation platforms such as Kneat is highly desirable. This position requires an individual who can work independently while collaborating cross-functionally with ...
Project Manager
Indianapolis, IN · On-site
Kneat or other software) is a major asset but not required. * Capital Improvements experience is a major asset but not required. Key Responsibilities: * Lead all CQV project activities for ...
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Project Manager
Indianapolis, IN · On-site
Kneat or other software) is a major asset but not required. * Capital Improvements experience is a major asset but not required. Key Responsibilities: * Lead all CQV project activities for ...
Senior Cleaning Validation Engineer (On-Floor Execution Lead) - (JP15180)
Holly Springs, NC · On-site
$55 - $65/hr
Proficient with KNEAT * Demonstrated track record of leading and executing cleaning validation studies and knowledge of CV lifecycle * Proficient with CIP/SIP cycles and process understanding to ...
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Senior Cleaning Validation Engineer (On-Floor Execution Lead) - (JP15180)
Holly Springs, NC · On-site
$55 - $65/hr
Proficient with KNEAT * Demonstrated track record of leading and executing cleaning validation studies and knowledge of CV lifecycle * Proficient with CIP/SIP cycles and process understanding to ...
Validation Specialist
Juncos, PR · On-site
Utilize systems such as LIMS , Kneat , and handle Batch Records (BI's) and documentation systems with accuracy and completeness. * Participate in the scheduling, setup, and monitoring of equipment ...
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Validation Specialist
Juncos, PR · On-site
Utilize systems such as LIMS , Kneat , and handle Batch Records (BI's) and documentation systems with accuracy and completeness. * Participate in the scheduling, setup, and monitoring of equipment ...
Kneat or other software) is a major asset but not required. * Capital Improvements experience is a major asset but not required. Key Responsibilities * Lead all CQV project activities for ...
Kneat or other software) is a major asset but not required. * Capital Improvements experience is a major asset but not required. Key Responsibilities * Lead all CQV project activities for ...
Proficient with KNEAT execution * Design and develop cleaning procedures for new products and manufacturing equipment. * Investigates and conducts troubleshooting/root cause analysis of cleaning ...
Proficient with KNEAT execution * Design and develop cleaning procedures for new products and manufacturing equipment. * Investigates and conducts troubleshooting/root cause analysis of cleaning ...
Experience with Kneat, ValGenesis, or Veeva is desirable * Experience with facility startup and commissioning #LI-ONSITE
Experience with Kneat, ValGenesis, or Veeva is desirable * Experience with facility startup and commissioning #LI-ONSITE
Experience with Kneat, ValGenesis, or Veeva is desirable * Experience with facility startup and commissioning #LI-ONSITE
Experience with Kneat, ValGenesis, or Veeva is desirable * Experience with facility startup and commissioning #LI-ONSITE
Experience with testing tools (ALM, or Kneat or ValGenesis). * Experience with ServiceNow (Change Module), Track wise (CAPA, Deviations, Change), Veeva document management, CAPA, Deviations, Change ...
Experience with testing tools (ALM, or Kneat or ValGenesis). * Experience with ServiceNow (Change Module), Track wise (CAPA, Deviations, Change), Veeva document management, CAPA, Deviations, Change ...
Validation Engineer
Raleigh, NC · On-site
Support execution within electronic validation systems such as KNEAT Skills & Experience: * 2+ years of experience supporting cleaning validation in GMP-regulated environments * Experience with ...
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Validation Engineer
Raleigh, NC · On-site
Support execution within electronic validation systems such as KNEAT Skills & Experience: * 2+ years of experience supporting cleaning validation in GMP-regulated environments * Experience with ...
Develop and execute test scripts in ALM, Kneat test tools to support system owners/IT Application Owners. Ensure and track computer systems periodic reviews and periodic access reviews are completed ...
Develop and execute test scripts in ALM, Kneat test tools to support system owners/IT Application Owners. Ensure and track computer systems periodic reviews and periodic access reviews are completed ...
Validation Specialist
Juncos, PR · On-site
Utilize systems such as LIMS , Kneat , and handle Batch Records (BI's) and documentation systems with accuracy and completeness. * Participate in the scheduling, setup, and monitoring of equipment ...
Validation Specialist
Juncos, PR · On-site
Utilize systems such as LIMS , Kneat , and handle Batch Records (BI's) and documentation systems with accuracy and completeness. * Participate in the scheduling, setup, and monitoring of equipment ...
Kneat information
What are the key skills and qualifications needed to thrive as a Kneat Validation Specialist, and why are they important?
To thrive as a Kneat Validation Specialist, you need a strong background in computer system validation, knowledge of GMP regulations, and experience in life sciences, often supported by a degree in a relevant field. Familiarity with the Kneat Gx platform, electronic validation tools, and documentation management systems is essential. Excellent analytical skills, attention to detail, and strong interpersonal communication help ensure thorough, compliant validation processes and smooth collaboration with cross-functional teams. These competencies are crucial for ensuring regulatory compliance, data integrity, and efficient validation workflows in highly regulated industries.
How does a role at Kneat typically collaborate with cross-functional teams in the implementation of digital validation solutions?
At Kneat, professionals regularly interact with cross-functional teams comprising IT, quality assurance, and business stakeholders to implement and optimize digital validation solutions. Collaboration often involves gathering requirements, customizing software workflows, and supporting user adoption through training and troubleshooting. Effective communication and project management skills are essential, as team members coordinate timelines, address challenges, and ensure regulatory compliance throughout the project lifecycle. This collaborative environment fosters continuous learning and exposure to diverse perspectives, which can accelerate professional growth.
What is a Kneat specialist?
A Kneat specialist is a professional who works with Kneat, a software platform widely used in regulated industries like pharmaceuticals and life sciences for managing validation, quality, and compliance documentation. These specialists are responsible for implementing, configuring, and supporting the Kneat software to streamline documentation processes and ensure regulatory compliance. Their role often involves collaborating with quality assurance, IT, and production teams to optimize workflows, train users, and maintain data integrity.
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Contractor
Posted 2 days ago
Job description
Inteldot has over 15 years in the life sciences industry, with operations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
Employment type: Full time and onsite role
Role Summary
The Compliance Engineer supports GMP compliance activities within capital project execution and site engineering functions in a regulated pharmaceutical manufacturing environment. This role ensures proper management of investigations, CAPAs, documentation control, and compliance metrics while supporting adherence to GMP standards, regulatory requirements, and internal quality systems.
Key Responsibilities
Requirements & Qualifications
Preferred Qualifications
Employment type: Full time and onsite role
Role Summary
The Compliance Engineer supports GMP compliance activities within capital project execution and site engineering functions in a regulated pharmaceutical manufacturing environment. This role ensures proper management of investigations, CAPAs, documentation control, and compliance metrics while supporting adherence to GMP standards, regulatory requirements, and internal quality systems.
Key Responsibilities
- Manage investigations and Corrective and Preventive Actions (CAPAs) arising from Project Execution and Site Engineering teams.
- Monitor GMP compliance metrics, including training completion, change control on-time closure, and CAPA effectiveness and timeliness.
- Conduct GMP reviews of project and site documentation to ensure compliance with regulatory and internal standards.
- Revise and maintain controlled documents using systems such as TrackWise (TV) and Kneat.
- Support document lifecycle management, ensuring accuracy, completeness, and compliance with GMP requirements.
- Facilitate new hire onboarding processes, including generation of required forms and IAM ticket submission and tracking.
- Collaborate with engineering, quality, and operations teams to ensure timely resolution of compliance-related issues.
- Support continuous improvement initiatives related to compliance processes and documentation practices.
Requirements & Qualifications
- Bachelor's degree in engineering or related technical discipline.
- Minimum 3 years of experience managing capital projects in the pharmaceutical industry.
- Experience with manufacturing and packaging processes and equipment in synthetic and/or biotherapeutic environments.
- Strong understanding of GMP regulations and quality systems.
- Experience managing CAPAs, investigations, and change control processes.
- Familiarity with electronic quality systems such as TrackWise (TV), Kneat, or equivalent platforms.
- Strong documentation review, analytical, and problem-solving skills.
- Bilingual (Spanish and English).
Preferred Qualifications
- Experience supporting pharmaceutical manufacturing or site engineering compliance activities.
- Knowledge of data integrity and audit readiness expectations.
- Familiarity with onboarding processes, IAM systems, and controlled document workflows.
- Experience working in cross-functional GMP-regulated environments.