CQV Services Specialist
Mirus Consulting Group, Bradenton, FL, United States
mîrus Consulting Group
is a Puerto Rico based technical services firm headquartered in Humacao. The company specializes in Computer System Validation (CSV) and Information Technology consulting for the pharmaceutical and life sciences industries across Puerto Rico and parts of the United States. Its services include the assessment and validation of automation systems, network infrastructures, and business processes, as well as comprehensive project management support to ensure compliance, efficiency, and operational excellence.
Position Summary
The CQV Services Specialist is responsible for planning, executing, and documenting all
Commissioning and Qualification (C&Q)
activities for laboratory equipment and computerized systems in a regulated pharmaceutical environment. This role supports compliance with
cGMP, FDA regulations, and data integrity requirements , ensuring laboratory instruments are fit for intended use. The scope of this project includes CQV activities for laboratory instrumentation, including
UPLC systems and a densitometer , in alignment with site and corporate quality systems.
Key Responsibilities
Lead and execute all
Commissioning & Qualification (C&Q)
lifecycle activities, including IQ, OQ, and PQ.
Develop, review, and execute C&Q documentation in accordance with site and regulatory requirements.
Author and revise validation protocols, test scripts, reports, and supporting documentation.
Support the validation of
computerized laboratory and manufacturing systems , including performance qualification and method configuration.
Ensure compliance with
cGMP, GAMP, SDLC, FDA regulations, 21 CFR Part 11, and Data Integrity
principles.
Execute and support
Change Control
activities related to laboratory instruments and computerized systems.
Interface with quality, IT, engineering, and laboratory stakeholders to support validation activities.
Maintain traceability and documentation within approved quality systems and repositories.
Ensure project deliverables are completed on time and in compliance with internal and external requirements.
Minimum Qualifications
Bachelor’s degree or higher
in Chemistry, Biology, Microbiology, Computer Science, Information Systems, Engineering, or a related scientific or technical discipline.
Minimum of three (3) years of experience
in pharmaceutical laboratory or manufacturing environments, preferably at
BMS Manatí .
Demonstrated experience commissioning and validating
laboratory and manufacturing computerized systems .
Hands-on experience with IQ/OQ/PQ execution and method configuration.
Strong working knowledge of:
cGMP regulations
GAMP guidelines
SDLC
FDA regulations
21 CFR Part 11
Data Integrity requirements
Experience with
Change Control processes
and computerized systems with data collection software.
Bilingual
(English/Spanish) with strong
technical writing
skills.
Preferred Qualifications
Knowledge in:
Veeva / Infinity
Maximo
ALM
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.
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is a Puerto Rico based technical services firm headquartered in Humacao. The company specializes in Computer System Validation (CSV) and Information Technology consulting for the pharmaceutical and life sciences industries across Puerto Rico and parts of the United States. Its services include the assessment and validation of automation systems, network infrastructures, and business processes, as well as comprehensive project management support to ensure compliance, efficiency, and operational excellence.
Position Summary
The CQV Services Specialist is responsible for planning, executing, and documenting all
Commissioning and Qualification (C&Q)
activities for laboratory equipment and computerized systems in a regulated pharmaceutical environment. This role supports compliance with
cGMP, FDA regulations, and data integrity requirements , ensuring laboratory instruments are fit for intended use. The scope of this project includes CQV activities for laboratory instrumentation, including
UPLC systems and a densitometer , in alignment with site and corporate quality systems.
Key Responsibilities
Lead and execute all
Commissioning & Qualification (C&Q)
lifecycle activities, including IQ, OQ, and PQ.
Develop, review, and execute C&Q documentation in accordance with site and regulatory requirements.
Author and revise validation protocols, test scripts, reports, and supporting documentation.
Support the validation of
computerized laboratory and manufacturing systems , including performance qualification and method configuration.
Ensure compliance with
cGMP, GAMP, SDLC, FDA regulations, 21 CFR Part 11, and Data Integrity
principles.
Execute and support
Change Control
activities related to laboratory instruments and computerized systems.
Interface with quality, IT, engineering, and laboratory stakeholders to support validation activities.
Maintain traceability and documentation within approved quality systems and repositories.
Ensure project deliverables are completed on time and in compliance with internal and external requirements.
Minimum Qualifications
Bachelor’s degree or higher
in Chemistry, Biology, Microbiology, Computer Science, Information Systems, Engineering, or a related scientific or technical discipline.
Minimum of three (3) years of experience
in pharmaceutical laboratory or manufacturing environments, preferably at
BMS Manatí .
Demonstrated experience commissioning and validating
laboratory and manufacturing computerized systems .
Hands-on experience with IQ/OQ/PQ execution and method configuration.
Strong working knowledge of:
cGMP regulations
GAMP guidelines
SDLC
FDA regulations
21 CFR Part 11
Data Integrity requirements
Experience with
Change Control processes
and computerized systems with data collection software.
Bilingual
(English/Spanish) with strong
technical writing
skills.
Preferred Qualifications
Knowledge in:
Veeva / Infinity
Maximo
ALM
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.
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