ZipRecruiter

Log In

1

Computer System Validation Csv Pharmaceutical Jobs in Michigan

Soliant Health

Pharmacist | Ann Arbor, Michigan

Ann Arbor, MI · On-site

$57 - $68.50/hr

Familiarity with Care Tend computer system is a plus, but not mandatory This role is ideal for a pharmacist who is detail-oriented and knowledgeable about sterile compounding standards within a home ...

Luxoft

Senior System Test Tools Developer

Troy, MI · On-site

$80 - $110/hr

System Validation test benches: closed loop HIL, reinjection HIL, system integration test bench ... Experience in Image Processing, Video pipeline and Computer vision. * Experience with requirements ...

previous page

Showing results 41-60

All JobsComputer System Validation Csv Pharmaceutical JobsComputer System Validation Csv Pharmaceutical Jobs in Michigan

Computer System Validation Csv Pharmaceutical information

What is computer system validation (CSV) in the pharmaceutical industry?

Computer System Validation (CSV) in the pharmaceutical industry is a process used to ensure that computerized systems used in drug manufacturing and related processes work as intended and comply with regulatory standards, such as FDA 21 CFR Part 11. CSV involves planning, testing, documenting, and maintaining systems to guarantee the accuracy, reliability, and integrity of data. This is critical for patient safety and product quality, as well as for meeting legal and regulatory requirements. The process typically includes risk assessment, validation planning, protocol execution, and ongoing monitoring of system performance.

What are common challenges faced by computer system validation (CSV) professionals in the pharmaceutical industry?

CSV professionals in the pharmaceutical industry often encounter challenges such as keeping up with evolving regulatory requirements, managing documentation for audits, and ensuring thorough validation of complex systems within tight project timelines. Collaboration with cross-functional teams, such as IT, quality assurance, and manufacturing, is essential to address technical and compliance issues. Additionally, balancing the need for robust validation with operational efficiency requires strong communication and project management skills.

What are the key skills and qualifications needed to thrive as a computer system validation (CSV) professional in the pharmaceutical industry?

To thrive as a Computer System Validation (CSV) professional in pharmaceuticals, you need a strong background in life sciences or engineering, knowledge of regulatory standards (such as FDA 21 CFR Part 11), and experience with validation protocols. Familiarity with validation lifecycle management tools, quality management systems (QMS), and industry guidelines like GAMP 5 is typically required, along with certifications such as ISPE or PMP being advantageous. Outstanding attention to detail, analytical thinking, and strong communication skills help ensure compliance and effective coordination with cross-functional teams. These competencies are vital for maintaining regulatory compliance, data integrity, and patient safety in pharmaceutical operations.

What is the difference between Computer System Validation Csv Pharmaceutical vs Quality Assurance Specialist?

AspectComputer System Validation Csv PharmaceuticalQuality Assurance Specialist
CertificationsGxP, 21 CFR Part 11, Validation certificationsGxP, ISO, QA certifications
Work EnvironmentPharmaceutical manufacturing, regulated labsQuality departments across industries, including pharma
Employer & IndustryPharmaceutical companies, biotech firmsPharma, biotech, healthcare organizations
Primary FocusEnsuring computer systems meet validation and compliance standardsMaintaining quality standards and process improvements

Computer System Validation Csv Pharmaceutical specialists focus on validating computer systems to ensure compliance with industry regulations, while Quality Assurance Specialists oversee overall quality processes. Both roles require GxP knowledge and are vital in pharmaceutical environments, but their core responsibilities differ in scope and focus.

What are popular job titles related to Computer System Validation Csv Pharmaceutical jobs in Michigan?

For Computer System Validation Csv Pharmaceutical jobs in Michigan, the most frequently searched job titles are:

What job categories do people searching Computer System Validation Csv Pharmaceutical jobs in Michigan look for?

The top searched job categories for Computer System Validation Csv Pharmaceutical jobs in Michigan are:

What cities in Michigan are hiring for Computer System Validation Csv Pharmaceutical jobs?

Cities in Michigan with the most Computer System Validation Csv Pharmaceutical job openings:

Computer System Validation Csv Pharmaceutical jobs near you
Infographic showing various Computer System Validation Csv Pharmaceutical job openings in Michigan as of August 2026, with employment types broken down into 8% Internship, 77% Full Time, and 15% Part Time. Highlights an 92% In-person, and 8% Remote job distribution.

Senior Automation Engineer

Long Finch Technologies

Sylvan Beach, MI

$98K - $129K/yr

Full-time

Posted 5 days ago

Job description

Job Description:

·       Role requires a senior level automation engineer comfortable operating independently while supporting others.

·       No CSV authorship responsibility: CSV activities are supported indirectly through automation execution and issue resolution.

·       DeltaV DCS automation experience in pharmaceutical / biopharma manufacturing (DeltaV Batch experience is a must, not Continuous DeltaV)

·       Strong troubleshooting and problem solving skills in live manufacturing environments, including commissioning, issue triage, and rapid resolution under GMP constraints

·       Deep understanding of biopharma regulatory expectations (GMP, validation, ISA 88, GAMP) and ability to apply them during real time plant execution

JD:

·       Serve as an onsite DeltaV Automation Engineer supporting C&Q execution activities.

·       Work independently to troubleshoot, configure, and support DeltaV control system logic, phases, and automation components during C&Q.

·       Provide technical mentorship and guidance to junior engineers and intermediate engineers, answering questions and supporting issue resolution in real time.

·       Support C&Q activities including test execution support, issue investigation, remediation, and re test preparation related to automation scope.

·       Collaborate closely with Cognizant and client teams onsite to ensure automation behavior aligns with approved Functional Specifications and test expectations.

·       Respond to automation related questions arising during commissioning and qualification activities.

·       Identify automation issues, propose technical solutions, and support implementation under change control where required.

·       Maintain compliance with applicable GMP requirements and site procedures during onsite execution.

·       Years of Experience:     12.00 Years of Experience

Apply