Mirus Consulting Group
IT & Automation Systems Subject Matter Expert (SME)
Mirus Consulting Group, Bradenton, Florida, 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.
Summary The IT & Automation Systems SME lead end-to-end lifecycle activities— installation, configuration, integration, troubleshooting, maintenance, qualification, upgrades, and CSV —for
manufacturing and utilities computerized systems . You will be the go‑to expert across
PLCs, HMI, DeltaV, FactoryTalk, SCADA, DCS/BAS, MES, databases, report engines, networking, communication interfaces, and printers . This role requires
strong project leadership , deep knowledge of
cGMP and 21 CFR Part 11 ,
data integrity , and a proven ability to
deliver validated, compliant systems
while partnering with Manufacturing, Quality, IT, and Engineering.
Key Responsibilities
Lead IT/Automation
activities for system installation, configuration, troubleshooting, and qualification.
Implement software/hardware changes and recommend process improvements using advanced technologies.
Support and execute Computer System Validation ( CSV ) and ensure compliance with cGMP and
data integrity
standards.
Collaborate with cross‑functional teams on automation projects and provide technical consulting.
Review design changes, manage
change controls , and maintain validated system states.
Provide user training, documentation, and ongoing support for automated systems.
Assist in audits,
CAPAs , and regulatory compliance activities.
Contribute to
cybersecurity , data integrity initiatives, and disaster recovery planning.
Qualifications
Bachelor’s Degree
in Engineering, Computer Science, Information Systems, or related field.
Minimum
5 years
in pharmaceutical operations, including 4 years in process automation and 2 years in CSV.
Bilingual
(English/Spanish).
Strong knowledge of
computer system lifecycle, change control,
and FDA regulations ( 21 CFR Part 11 ).
Experience with
PLC programming, MES systems, SCADA, DeltaV, FactoryTalk, and networking.
Familiarity with
data historians (OSI PI), MS SQL databases, and electrical/mechanical drawings.
Proven
project management
and problem‑solving skills.
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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Summary The IT & Automation Systems SME lead end-to-end lifecycle activities— installation, configuration, integration, troubleshooting, maintenance, qualification, upgrades, and CSV —for
manufacturing and utilities computerized systems . You will be the go‑to expert across
PLCs, HMI, DeltaV, FactoryTalk, SCADA, DCS/BAS, MES, databases, report engines, networking, communication interfaces, and printers . This role requires
strong project leadership , deep knowledge of
cGMP and 21 CFR Part 11 ,
data integrity , and a proven ability to
deliver validated, compliant systems
while partnering with Manufacturing, Quality, IT, and Engineering.
Key Responsibilities
Lead IT/Automation
activities for system installation, configuration, troubleshooting, and qualification.
Implement software/hardware changes and recommend process improvements using advanced technologies.
Support and execute Computer System Validation ( CSV ) and ensure compliance with cGMP and
data integrity
standards.
Collaborate with cross‑functional teams on automation projects and provide technical consulting.
Review design changes, manage
change controls , and maintain validated system states.
Provide user training, documentation, and ongoing support for automated systems.
Assist in audits,
CAPAs , and regulatory compliance activities.
Contribute to
cybersecurity , data integrity initiatives, and disaster recovery planning.
Qualifications
Bachelor’s Degree
in Engineering, Computer Science, Information Systems, or related field.
Minimum
5 years
in pharmaceutical operations, including 4 years in process automation and 2 years in CSV.
Bilingual
(English/Spanish).
Strong knowledge of
computer system lifecycle, change control,
and FDA regulations ( 21 CFR Part 11 ).
Experience with
PLC programming, MES systems, SCADA, DeltaV, FactoryTalk, and networking.
Familiarity with
data historians (OSI PI), MS SQL databases, and electrical/mechanical drawings.
Proven
project management
and problem‑solving skills.
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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