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Csv Validation Jobs in Michigan (NOW HIRING)

Biovire

Manager, Validation

Brighton, MI · On-site

$100K - $120K/yr

The RoleThe Manager, Validation leads commissioning, qualification, validation (CQV), and computer system validation (CSV) activities across the Brighton site. This role provides technical oversight ...

Biovire

Manager, Validation

Brighton, MI · On-site

The Role The Manager, Validation leads commissioning, qualification, validation (CQV), and computer system validation (CSV) activities across the Brighton site. This role provides technical oversight ...

Biovire

Head of Validation

Brighton, MI · On-site

The Role The Manager, Validation leads commissioning, qualification, validation (CQV), and computer system validation (CSV) activities across the Brighton site. This role provides technical oversight ...

BoehringerPRD

Understands content and compliance requirements for related CSV deliverables and uses this knowledge to improve consistency across the system validation portfolio. * Applies in-depth knowledge and ...

Clarkston Consulting

LIMS Consultant

Detroit, MI · On-site +1

Collaborate with scientists, QA/CSV teams, and IT to gather requirements, design technical solutions, and support system validation activities (URS, FRS, DS, IQ/OQ/PQ) * Ensure configurations comply ...

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Csv Validation information

What are the key skills and qualifications needed to thrive in the csv validation position, and why are they important?

To excel in CSV Validation, a strong background in life sciences, engineering, or a related technical discipline is essential, along with knowledge of computer system validation regulations and best practices. Familiarity with FDA 21 CFR Part 11, GAMP guidelines, and validation software tools is highly valued, and certifications such as PMP or CISA can be beneficial. Attention to detail, analytical thinking, and effective communication skills help professionals manage documentation and collaborate with cross-functional teams. These abilities ensure that systems in regulated environments are compliant, reliable, and meet industry standards for quality and data integrity.

What are the typical daily responsibilities of a csv validation professional?

CSV (Computer System Validation) Validation professionals are responsible for planning, executing, and documenting validation activities for computerized systems used in regulated industries like pharmaceuticals and biotechnology. Their daily tasks include reviewing system requirements, developing validation protocols, conducting risk assessments, performing validation testing, and documenting results in accordance with regulatory standards. They regularly collaborate with IT, quality assurance, and business stakeholders to ensure systems are compliant and audit-ready. Staying organized and detail-oriented is crucial, as each step must be carefully documented and verified for compliance. This role is dynamic and requires balancing technical tasks with frequent cross-functional communication.

What is a csv validation?

A CSV Validation job involves verifying the accuracy, consistency, and integrity of data within CSV files. This role ensures that the data conforms to predefined formats, standards, and business rules. It often includes checking for missing values, incorrect data types, and formatting errors to prevent issues in data processing. Professionals in this role may use scripts, validation tools, or manual reviews to ensure data quality and compliance.

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Csv Validation jobs near you
Infographic showing various Csv Validation job openings in Michigan as of August 2026, with employment types broken down into 89% Full Time, 3% Part Time, and 8% Contract. Highlights an 87% Physical, 4% Hybrid, and 9% 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.