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Biotech Csv Jobs in Michigan (NOW HIRING)

Biovire

Manager, Validation

Brighton, MI · On-site

$100K - $120K/yr

... CSV) activities across the Brighton site. This role provides technical oversight for validation ... biotechnology, or regulated manufacturing environments * Prior leadership experience within ...

Biovire

Manager, Validation

Brighton, MI

... CSV) activities across the Brighton site. This role provides technical oversight for validation ... biotechnology, or regulated manufacturing environments * Prior leadership experience within ...

Biovire

Manager, Validation

Brighton, MI · On-site

$100K - $120K/yr

... CSV) activities across the Brighton site. This role provides technical oversight for validation ... in pharmaceutical, biotechnology, or regulated manufacturing environmentsPrior leadership ...

Clarkston Consulting

LIMS Consultant

Detroit, MI · On-site +1

Collaborate with scientists, QA/CSV teams, and IT to gather requirements, design technical ... Experience working in regulated environments such as pharmaceuticals, biotechnology, or food safety

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Biotech Csv information

What is a Biotech CSV professional?

Biotech CSV (Computer System Validation) professionals are experts who ensure that computerized systems used in biotechnology and pharmaceutical industries meet regulatory requirements and function as intended. They are responsible for planning, executing, and documenting validation activities to ensure data integrity, product quality, and compliance with standards such as FDA 21 CFR Part 11. Their role is crucial in maintaining reliable and compliant technology solutions throughout the product lifecycle, helping companies avoid costly errors and regulatory penalties.

What are common challenges faced by Biotech CSV professionals when ensuring compliance with regulatory standards?

Biotech CSV (Computer System Validation) professionals often encounter challenges such as keeping pace with evolving regulatory requirements and ensuring that validation documentation is both thorough and audit-ready. Navigating the complexity of integrating new software or technologies into existing validated systems can also be demanding. Effective communication with cross-functional teams—such as quality assurance, IT, and laboratory staff—is crucial to address gaps and maintain compliance. Staying organized and proactive in risk management helps CSV professionals overcome these hurdles and support successful regulatory inspections.

What are the key skills and qualifications needed to thrive as a Biotech CSV specialist, and why are they important?

To thrive as a Biotech CSV Specialist, you need a solid understanding of computer system validation principles, regulatory compliance (such as FDA 21 CFR Part 11), and a background in life sciences or engineering. Familiarity with validation tools, quality management systems (QMS), and relevant software like TrackWise or MasterControl is crucial. Strong analytical thinking, attention to detail, and effective communication are standout soft skills in this role. These skills and qualities ensure validated systems meet regulatory standards, minimize compliance risks, and support reliable biotech research and manufacturing processes.

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For Biotech Csv jobs in Michigan, the most frequently searched job titles are:

What job categories do people searching Biotech Csv jobs in Michigan look for?

The top searched job categories for Biotech Csv jobs in Michigan are:

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Biotech Csv jobs near you

Manager, Validation

Biovire

Brighton, MI • On-site

$100K - $120K/yr

Full-time

Medical, Dental, Vision, Life, PTO

Re-posted 7 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 Role
The 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 Responsibilities
  • Lead 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 documentation
  • Lead scheduling, planning, review, and execution of validation activities
  • Support transition of equipment and systems from Engineering to operational use
  • Partner cross-functionally with Quality, Manufacturing, Engineering, and Maintenance teams
  • Provide technical guidance for risk assessments, change controls, deviations, and investigations
  • Ensure timely completion of validation protocols, reports, traceability matrices, IQ/OQ documentation, and related deliverables
  • Support audit and inspection readiness activities
  • Lead and develop validation personnel while reinforcing a strong quality and compliance culture

What You Bring
  • Bachelor's degree in Engineering, Science, Computer Systems, or related technical field
  • 5+ years of experience in pharmaceutical, biotechnology, or regulated manufacturing environments
  • Prior leadership experience within Validation, Engineering, CQV, or Quality functions
  • Experience 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 requirements
  • Hands-on experience leading validation projects and technical documentation activities
  • Experience supporting manufacturing equipment, utilities, HVAC, automation systems, and/or computerized systems
  • Strong organizational, communication, and cross-functional collaboration skills

Why Join Biovire
  • Opportunity to shape and strengthen validation systems during organizational growth
  • High visibility and cross-functional leadership exposure
  • Collaborative and mission-driven GMP manufacturing environment
  • Direct impact supporting operational readiness and future commercialization
  • Company-paid medical, dental, vision, and life insurance
  • Paid Time Off supporting work-life balance

Come join us on our mission of manufacturing safe, high-quality products that improve and save lives.

Apply