Manager, Validation Brighton, Michigan Biovire is advancing toward commercialization with a focus ... Direct impact supporting operational readiness and future commercialization * Company-paid medical ...
Manager, Validation Brighton, Michigan Biovire is advancing toward commercialization with a focus ... Direct impact supporting operational readiness and future commercialization * Company-paid medical ...
Manager, Validation
Brighton, MI · On-site
$100K - $120K/yr
Manager, Validation Brighton, Michigan Biovire is advancing toward commercialization with a focus ... Direct impact supporting operational readiness and future commercialization * Company-paid medical ...
Manager, Validation
Brighton, MI · On-site
$100K - $120K/yr
Manager, Validation Brighton, Michigan Biovire is advancing toward commercialization with a focus ... Direct impact supporting operational readiness and future commercialization * Company-paid medical ...
... directed, or who have needle-phobia. This is only the beginning! There's so much more to deliver ... Development of validation or qualification deliverables, performing testing, verification ...
... directed, or who have needle-phobia. This is only the beginning! There's so much more to deliver ... Development of validation or qualification deliverables, performing testing, verification ...
... direct or indirect reports and/or managing cross-functional projects focused on product validation ... and testing. * Demonstrated ability to interpret engineering drawings, specifications, test ...
... direct or indirect reports and/or managing cross-functional projects focused on product validation ... and testing. * Demonstrated ability to interpret engineering drawings, specifications, test ...
Senior Validation Engineer
Rochester, MI · On-site
$82K - $137K/yr
... direct impact on patient care. What You Will Achieve In this role, you will: * Evaluate, review ... Troubleshoot validation issues for equipment and performance processes, providing expertise for ...
Senior Validation Engineer
Rochester, MI · On-site
$82K - $137K/yr
... direct impact on patient care. What You Will Achieve In this role, you will: * Evaluate, review ... Troubleshoot validation issues for equipment and performance processes, providing expertise for ...
Senior Validation Engineer
Rochester, MI · On-site
$82K - $137K/yr
... direct impact on patient care. What You Will Achieve In this role, you will: * Evaluate, review ... Troubleshoot validation issues for equipment and performance processes, providing expertise for ...
Senior Validation Engineer
Rochester, MI · On-site
$82K - $137K/yr
... direct impact on patient care. What You Will Achieve In this role, you will: * Evaluate, review ... Troubleshoot validation issues for equipment and performance processes, providing expertise for ...
We are seeking an ADAS Sensing Systems Validation Engineer to validate and continuously improve the ... Experience in project management and/or an integration role, leading and directing other team ...
New
We are seeking an ADAS Sensing Systems Validation Engineer to validate and continuously improve the ... Experience in project management and/or an integration role, leading and directing other team ...
New
Verification and Validation Engineer
Dearborn, MI · On-site
$115K - $162K/yr
Experience in project management and/or an integration role, leading and directing other team ... Develop, refine, and execute design validation methods to ensure sensing system performance at the ...
New
Verification and Validation Engineer
Dearborn, MI · On-site
$115K - $162K/yr
Experience in project management and/or an integration role, leading and directing other team ... Develop, refine, and execute design validation methods to ensure sensing system performance at the ...
New
The Development & Validation Engineer for Automatic Transmission, Driveline and/or Gear Reducers is ... Candidate must be highly motivated, self-directed, have the ability to manage multiple complex ...
The Development & Validation Engineer for Automatic Transmission, Driveline and/or Gear Reducers is ... Candidate must be highly motivated, self-directed, have the ability to manage multiple complex ...
The Development & Validation Engineer for Automatic Transmission, Driveline and/or Gear Reducers is ... Candidate must be highly motivated, self-directed, have the ability to manage multiple complex ...
The Development & Validation Engineer for Automatic Transmission, Driveline and/or Gear Reducers is ... Candidate must be highly motivated, self-directed, have the ability to manage multiple complex ...
In this position, the Student will aid the validation group on performing tests and other ... This includes direct company sponsorship, entry of Nexteer as the immigration employer of record on ...
In this position, the Student will aid the validation group on performing tests and other ... This includes direct company sponsorship, entry of Nexteer as the immigration employer of record on ...
The Development & Validation Engineer for Automatic Transmission, Driveline and/or Gear Reducers is ... Candidate must be highly motivated, self-directed, have the ability to manage multiple complex ...
The Development & Validation Engineer for Automatic Transmission, Driveline and/or Gear Reducers is ... Candidate must be highly motivated, self-directed, have the ability to manage multiple complex ...
The Development & Validation Engineer for Automatic Transmission, Driveline and/or Gear Reducers is ... Candidate must be highly motivated, self-directed, have the ability to manage multiple complex ...
The Development & Validation Engineer for Automatic Transmission, Driveline and/or Gear Reducers is ... Candidate must be highly motivated, self-directed, have the ability to manage multiple complex ...
In this position, the Student will aid the validation group on performing tests and other ... This includes direct company sponsorship, entry of Nexteer as the immigration employer of record on ...
In this position, the Student will aid the validation group on performing tests and other ... This includes direct company sponsorship, entry of Nexteer as the immigration employer of record on ...
In this position, the Student will aid the validation group on performing tests and other ... This includes direct company sponsorship, entry of Nexteer as the immigration employer of record on ...
In this position, the Student will aid the validation group on performing tests and other ... This includes direct company sponsorship, entry of Nexteer as the immigration employer of record on ...
Work with validation engineers and lab team to understand the processes of the lab including the ... This includes direct company sponsorship, entry of Nexteer as the immigration employer of record on ...
Work with validation engineers and lab team to understand the processes of the lab including the ... This includes direct company sponsorship, entry of Nexteer as the immigration employer of record on ...
Work with validation engineers and lab team to understand the processes of the lab including the ... This includes direct company sponsorship, entry of Nexteer as the immigration employer of record on ...
Work with validation engineers and lab team to understand the processes of the lab including the ... This includes direct company sponsorship, entry of Nexteer as the immigration employer of record on ...
This role is responsible for the design, development, testing, and validation of automatic ... Candidate must be highly motivated, self-directed, have the ability to manage multiple complex ...
This role is responsible for the design, development, testing, and validation of automatic ... Candidate must be highly motivated, self-directed, have the ability to manage multiple complex ...
Work with validation engineers and lab team to understand the processes of the lab including the ... This includes direct company sponsorship, entry of Nexteer as the immigration employer of record on ...
Work with validation engineers and lab team to understand the processes of the lab including the ... This includes direct company sponsorship, entry of Nexteer as the immigration employer of record on ...
Sterility Assurance Validation Engineer/Specialist I/II/III Agility, Impact, Methodology. Do you ... Work on any assignment as directed and flexibility to support limited multi-shift operations ...
Sterility Assurance Validation Engineer/Specialist I/II/III Agility, Impact, Methodology. Do you ... Work on any assignment as directed and flexibility to support limited multi-shift operations ...
Director Validation information
What does a director validation do?
A Director of Validation oversees the validation processes in industries like pharmaceuticals, biotechnology, or medical devices to ensure compliance with regulatory standards. They develop and implement validation strategies for equipment, processes, and systems, ensuring they meet quality and safety requirements. This role involves managing validation teams, coordinating with regulatory bodies, and maintaining documentation to support audits and inspections. The Director also ensures adherence to industry guidelines such as FDA, EMA, or ISO standards.
What are the typical daily responsibilities of a director validation in a regulated industry?
A Director Validation typically oversees the planning, execution, and review of validation projects to ensure compliance with regulatory requirements. Daily responsibilities include leading teams, reviewing validation protocols and reports, coordinating with quality, engineering, and regulatory departments, and addressing any deviations or issues that arise during validation activities. The role may also involve direct communication with regulatory agencies during audits and inspections. This ensures products or processes meet the highest standards of quality and regulatory compliance, ultimately supporting the company’s overall operational success.
What are the key skills and qualifications needed to thrive in the director validation position, and why are they important?
To thrive as a Director Validation, you need extensive experience in validation processes, regulatory compliance, quality assurance, and a relevant scientific or engineering degree. Familiarity with industry standards, validation lifecycle management software, and certifications such as Six Sigma or PMP are highly valued. Strong leadership, strategic thinking, and excellent communication skills help to drive complex projects and foster cross-functional collaboration. These skills are vital to ensuring validated processes meet regulatory standards and support organizational goals efficiently.
What are the most commonly searched types of Validation jobs in Michigan?
The most popular types of Validation jobs in Michigan are:
What are popular job titles related to Director Validation jobs in Michigan?
For Director Validation jobs in Michigan, the most frequently searched job titles are:
What job categories do people searching Director Validation jobs in Michigan look for?
The top searched job categories for Director Validation jobs in Michigan are:
What cities in Michigan are hiring for Director Validation jobs?
Cities in Michigan with the most Director Validation job openings:
Full-time
Medical, Dental, Vision, Life, PTO
Re-posted yesterday
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.