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Computer System Validation Csv Pharmaceutical Jobs in Michigan

Biovire

Manager, Validation

Brighton, MI · On-site

$100K - $120K/yr

... and computer system validation (CSV) activities across the Brighton site. This role provides ... in pharmaceutical, biotechnology, or regulated manufacturing environmentsPrior leadership ...

Biovire

Manager, Validation

Brighton, MI · On-site

... and computer system validation (CSV) activities across the Brighton site. This role provides ... pharmaceutical, biotechnology, or regulated manufacturing environments * Prior leadership ...

Biovire

Head of Validation

Brighton, MI · On-site

... and computer system validation (CSV) activities across the Brighton site. This role provides ... pharmaceutical, biotechnology, or regulated manufacturing environments * Prior leadership ...

BoehringerPRD

... computer system and computerized equipment validation within BIAH Operations, including program ... Understands content and compliance requirements for related CSV deliverables and uses this ...

Deloitte

System Test and Validation Lead

Midland, MI · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Deloitte

System Test and Validation Lead

Midland, MI · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Deloitte

System Test and Validation Lead

Detroit, MI · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Deloitte

System Test and Validation Lead

Detroit, MI · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Deloitte

System Test and Validation Lead

Midland, MI · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

Deloitte

System Test and Validation Lead

Detroit, MI · On-site +1

Bachelor's degree in business, information systems, computer science, engineering, or equivalent experience; 6+ years of experience in computer system validation in a life sciences environment ...

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

Computer System Validation Csv Pharmaceutical information

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 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 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.
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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.

Manager, Validation

Biovire

Brighton, MI • On-site

$100K - $120K/yr

Full-time

Medical, Dental, Vision, Life

Re-posted 23 days ago

Job description

Manager, Validation Brighton, Michigan Biovire is advancing toward commercialization with a focus on operational excellence, compliance, and scalable GMP manufacturing systems. We are seeking a Manager, Validation, reporting to the VP, Engineering, to lead validation programs supporting equipment, facilities, utilities, and computerized systems within our regulated pharmaceutical manufacturing environment.This is a highly visible leadership role responsible for ensuring validation programs support operational readiness, inspection readiness, and long-term manufacturing reliability as the organization continues to scale. The RoleThe Manager, Validation leads commissioning, qualification, validation (CQV), and computer system validation (CSV) activities across the Brighton site. This role provides technical oversight for validation strategy, execution, compliance, and lifecycle management of manufacturing systems and infrastructure.This position partners closely with Quality, Operations, Manufacturing, Engineering, Maintenance, and cross-functional operational teams to ensure all systems remain compliant, qualified, and inspection-ready. Key ResponsibilitiesLead enterprise validation programs supporting equipment, facilities, utilities, automation, and computerized systems across Biovire's GMP manufacturing operations.Oversee commissioning, qualification, and the overall validation strategy and activities.Partner with Operations and Quality to maintain the qualified state of manufacturing systems.Support commercialization, technology transfer, process validation, and startup activities for new manufacturing processes and facilities.Serve as Validation SME during FDA and regulatory inspections.Lead lifecycle management of validation systems.Manage and maintain Validation Master Plans and validation lifecycle documentationLead scheduling, planning, review, and execution of validation activitiesSupport transition of equipment and systems from Engineering to operational usePartner cross-functionally with Quality, Manufacturing, Engineering, and Maintenance teamsProvide technical guidance for risk assessments, change controls, deviations, and investigationsEnsure timely completion of validation protocols, reports, traceability matrices, IQ/OQ documentation, and related deliverablesSupport audit and inspection readiness activitiesLead and develop validation personnel while reinforcing a strong quality and compliance culture What You BringBachelor's degree in Engineering, Science, Computer Systems, or related technical field5+ years of experience in pharmaceutical, biotechnology, or regulated manufacturing environmentsPrior leadership experience within Validation, Engineering, CQV, or Quality functionsExperience interacting with FDA or other regulatory agencies and supporting inspections.Ability to communicate technical validation concepts during inspections.Strong understanding of cGMP, validation lifecycle management, and 21 CFR Part 11 requirementsHands-on experience leading validation projects and technical documentation activitiesExperience supporting manufacturing equipment, utilities, HVAC, automation systems, and/or computerized systemsStrong organizational, communication, and cross-functional collaboration skills Why Join BiovireOpportunity to shape and strengthen validation systems during organizational growthHigh visibility and cross-functional leadership exposureCollaborative and mission-driven GMP manufacturing environmentDirect impact supporting operational readiness and future commercializationCompany-paid medical, dental, vision, and life insurancePaid Time Off supporting work-life balance Come join us on our mission of manufacturing safe, high-quality products that improve and save lives.