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Csv Validation Jobs in Michigan (NOW HIRING)

Biovire

Director, Validation

Brighton, MI · On-site

$100K - $120K/yr

Provide strategic and technical leadership for CQV and CSV, including appropriate lifecycle governance and maintenance of the validated state. * Build and develop organizational capability across ...

Biovire

Director, Validation

Brighton, MI · On-site

Provide strategic and technical leadership for CQV and CSV, including appropriate lifecycle governance and maintenance of the validated state. * Build and develop organizational capability across ...

Biovire

Director, Validation

Brighton, MI · On-site

Provide strategic and technical leadership for CQV and CSV, including appropriate lifecycle governance and maintenance of the validated state.Build and develop organizational capability across ...

Long Finch Technologies

Senior Automation Engineer

Nunica, MI · On-site

$95K - $124K/yr

CSV activities are supported indirectly through automation execution and issue resolution. · ... validation, ISA 88, GAMP) and ability to apply them during real time plant execution JD: · Serve ...

Long Finch Technologies

Senior Automation Engineer

Holton, MI · On-site

$94K - $124K/yr

CSV activities are supported indirectly through automation execution and issue resolution. · ... validation, ISA 88, GAMP) and ability to apply them during real time plant execution JD: · Serve ...

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Csv Validation information

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.

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 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 popular job titles related to Csv Validation jobs in Michigan?

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

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

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

What cities in Michigan are hiring for Csv Validation jobs?

Cities in Michigan with the most Csv Validation job openings:

Csv Validation jobs near you
Infographic showing various Csv Validation job openings in Michigan as of August 2026, with employment types broken down into 83% Full Time, 13% Part Time, and 4% Contract. Highlights an 84% Physical, 5% Hybrid, and 11% Remote job distribution.

Director, Validation

Brighton, MI • On-site

Biovire
See more jobs at Biovireexternal

$100K - $120K/yr

Full-time

Medical, Dental, Vision, Life, PTO

Re-posted 15 days ago

Job description

Director, Validation Brighton, Michigan
Biovire is advancing toward commercialization with a focus on operational excellence, technical capability, compliance, and scalable GMP manufacturing systems. We are seeking an experienced Director, Validation, reporting to the Vice President of Engineering, to provide strategic and technical leadership for Validation across our Brighton manufacturing site.
This is a highly visible leadership role responsible for establishing and executing Biovire's site validation strategy across Commissioning, Qualification and Validation (CQV) and Computer System Validation (CSV). The Director will build organizational capability, strengthen validation governance, and ensure manufacturing equipment, facilities, utilities, automation, and computerized systems remain qualified, validated, compliant, and inspection-ready throughout their lifecycle.
The Role
The Director, Validation serves as Biovire's senior Validation leader and Subject Matter Expert, partnering closely with Engineering, Quality, Operations, Manufacturing, Maintenance & Calibration, IT, and other stakeholders as the organization expands and prepares for commercialization.
This leader will provide technical and organizational leadership across two major areas of validation expertise: Equipment, Facilities & Utilities Qualification and Computer Systems Validation. The Director will assess and develop the appropriate internal capabilities, technical SMEs, external resources, standards, and governance needed to support a sustainable site-wide Validation program.
The position will also represent Biovire as the senior Validation SME during FDA and other regulatory inspections and client audits, including presenting and defending validation strategies and responding directly to technical questions.
Key Responsibilities
  • Establish and execute the site-wide Validation strategy across equipment, facilities, utilities, automation, and computerized systems.
  • Own the Validation Master Plan and overall validation governance framework, ensuring alignment with regulatory expectations, business priorities, site expansion, and commercialization readiness.
  • Provide strategic and technical leadership for CQV and CSV, including appropriate lifecycle governance and maintenance of the validated state.
  • Build and develop organizational capability across Equipment, Facilities & Utilities Qualification and Computer Systems Validation.
  • Recruit, lead, coach, and develop technically strong Validation professionals and SMEs while establishing clear accountability and development pathways.
  • Serve as Biovire's senior Validation SME during FDA and other regulatory inspections and client audits, including preparation, presentation and defense of validation strategies, and responses to technical questions.
  • Provide technical leadership for commissioning, startup, site expansion, technology transfer, process validation, and implementation of new manufacturing equipment and systems.
  • Establish and oversee the Computer Systems Validation program, including application of GAMP 5, data integrity principles, electronic records/signatures requirements, and 21 CFR Part 11.
  • Provide technical oversight for validation plans, protocols, reports, traceability matrices, risk assessments, IQ/OQ/PQ documentation, qualification activities, and related deliverables.
  • Partner with Quality and Operations to ensure manufacturing systems transition effectively from Engineering into operational use and remain qualified and inspection ready.
  • Provide Validation leadership for risk assessments, change controls, deviations, discrepancies, investigations, and integration with CAPA and other Quality Systems.
  • Establish appropriate governance and technical oversight for validation contractors, consultants, vendors, and other external resources while developing sustainable internal capability.
  • Continuously assess Validation program health, identify technical and compliance risks, establish priorities, and drive sustainable improvement.
  • Build a culture of technical excellence, ownership, collaboration, accountability, inspection readiness, and continuous improvement.

What You Bring
  • Bachelor's degree in Engineering, Life Sciences, Computer Science, or another related technical discipline required; advanced degree preferred.
  • 10+ years of progressive Validation, Engineering, Quality, or related technical experience within pharmaceutical, biopharmaceutical, biotechnology, medical device, or another similarly regulated environment, including significant leadership responsibility.
  • Prior direct people leadership experience with demonstrated success developing technical professionals and building organizational capability.
  • Significant hands-on technical experience with equipment, facilities, and utilities commissioning and qualification, including IQ/OQ/PQ and risk-based qualification methodologies.
  • Demonstrated experience with Computer Systems Validation, GAMP 5, data integrity principles, and 21 CFR Part 11.
  • Strong knowledge of GMP manufacturing processes, process equipment, critical utilities, automation, computerized systems, and validation lifecycle management.
  • Demonstrated experience developing, critically reviewing, approving, and defending complex validation strategies and technical documentation.
  • Demonstrated experience serving in a technical leadership or SME capacity during FDA or other regulatory inspections and client audits, including presenting and defending validation strategies and responding directly to technical questions.
  • Experience managing complex validation programs, consultants, contractors, vendors, and external technical resources.
  • Ability to read and interpret architectural, mechanical, electrical and process drawings, P&IDs, equipment specifications, system architecture, and related technical documentation.
  • Strong executive communication, organizational, people leadership, program management, and cross-functional collaboration skills.

Why Join Biovire
  • Lead and shape a critical technical function as Biovire prepares for commercialization.
  • Build Validation capability and governance across both CQV and Computer Systems Validation.
  • Play a direct leadership role in site expansion, operational readiness, and regulatory inspection readiness.
  • Work cross-functionally with senior leaders across Engineering, Quality, Operations, and Manufacturing.
  • Opportunity to build and develop technical talent and sustainable organizational capability.
  • Company-paid medical, dental, vision, and life insurance.
  • Paid Time Off supporting work-life balance.
  • Collaborative, mission-driven GMP pharmaceutical manufacturing environment.

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

Apply