At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.
We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.
Achieve, Cooperate, Care and Innovate are the values that we share and practice on a daily basis.
Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.
For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube
WHAT WE ARE LOOKING FOR
Guerbet is seeking an experienced Validation Manager to lead validation activities supporting our pharmaceutical manufacturing operations. This role provides technical and people leadership for the Validation team while ensuring facilities, utilities, equipment, computerized systems, manufacturing processes, cleaning processes, and laboratory systems remain compliant with applicable regulatory and quality requirements.
As a key Validation subject matter expert, you will oversee the complete validation lifecycle, including qualification, validation, requalification, and revalidation programs. You will partner closely with Engineering, Manufacturing Science & Technology (MS&T), Operations, Quality Assurance, Regulatory Affairs, and other site teams to support manufacturing operations, capital projects, new product introductions, and continuous improvement.
The ideal candidate combines deep technical validation expertise with strong leadership skills and significant experience within cGMP pharmaceutical manufacturing, particularly parenteral or injectable operations.
YOUR ROLE
Validation Leadership
- Lead the day-to-day activities of the Validation department, including internal employees, specialists, and external validation contractors.
- Establish team priorities, assignments, objectives, and schedules to ensure validation activities are executed accurately, efficiently, and on time.
- Coach, mentor, and develop Validation team members while building strong technical capabilities across the function.
- Manage departmental resources and support performance management, workload planning, and development of team objectives.
- Serve as a site Validation subject matter expert (SME) and provide technical guidance to project teams and senior stakeholders.
- Effectively communicate validation risks, project status, resource needs, and recommendations to site leadership.
Validation & Qualification
- Provide leadership and technical oversight for validation and qualification activities involving:
- Manufacturing and laboratory equipment
- Facilities and classified areas
- Clean utilities
- Computerized systems
- Manufacturing processes
- Cleaning processes
- Steam sterilization
- Process validation
- Equipment qualification
- Oversee the development, execution, review, and approval of IQ/OQ/PQ protocols and reports.
- Ensure validation documentation is complete, technically sound, scientifically justified, and compliant with applicable requirements.
- Lead and maintain the site's revalidation and requalification program.
- Apply risk-based validation approaches to establish robust and defendable validation strategies.
- Review and assess change controls to determine validation impact and appropriate qualification or revalidation requirements.
Validation Program & Compliance
- Own and continuously improve the site's Validation Master Plan (VMP).
- Develop, maintain, and improve validation policies, procedures, standards, and supporting systems.
- Ensure validation activities comply with applicable cGMP/cGxP requirements and global regulatory expectations.
- Support internal audits, regulatory inspections, agency audits, and vendor audits as a Validation SME.
- Review deviations, change controls, risk assessments, CAPAs, and related GMP documentation for validation impact.
- Partner with Quality to identify validation-related quality issues and establish appropriate corrective and preventive actions.
- Maintain inspection readiness and ensure validation documentation supports regulatory expectations.
Capital Projects & Manufacturing Support
- Lead validation strategy and execution for large-scale capital projects, including projects requiring multiple qualification protocols and comprehensive validation plans.
- Support equipment commissioning and qualification activities associated with new or modified pharmaceutical manufacturing systems.
- Provide Validation leadership for new product introductions, process improvements, facility modifications, formulation, filling, and manufacturing initiatives.
- Partner with Engineering, MS&T, Operations, and QA to identify risks, resolve technical challenges, and maintain project timelines.
- Provide Validation input into project scope, resource planning, schedules, and execution strategies.
- Work with Regulatory Affairs to provide validation content and technical documentation supporting regulatory submissions.
Continuous Improvement
- Evaluate validation systems and processes to identify opportunities for increased efficiency, compliance, standardization, and technology improvements.
- Apply Lean, Six Sigma, root cause analysis, risk assessment, and structured problem-solving methodologies where appropriate.
- Lead Operational Excellence initiatives that streamline validation processes while maintaining compliance and scientific rigor.
- Identify and implement improvements that strengthen validation execution and overall site performance.
YOUR BACKGROUND
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, or a related scientific or technical discipline.
- 10+ years of validation experience within a pharmaceutical manufacturing environment.
- Significant experience leading validation teams, including direct supervision, coaching, and development of employees and/or contractors.
- Extensive knowledge of the validation lifecycle and IQ/OQ/PQ methodology.
- Hands-on experience with equipment commissioning and qualification (C&Q), process validation, cleaning validation, and sterilization validation.
- Demonstrated experience supporting pharmaceutical manufacturing equipment, facilities, utilities, and processes.
- Working knowledge of the science and technology associated with parenteral/injectable manufacturing and packaging operations.
- Strong knowledge of cGMP/cGxP requirements, FDA expectations, ICH guidance, and applicable European regulatory expectations.
- Experience evaluating change controls, deviations, risk assessments, CAPAs, and validation documentation.
- Demonstrated experience managing large and complex validation projects.
- Strong troubleshooting, root-cause analysis, and risk assessment/mitigation capabilities.
- Experience supporting regulatory audits and inspections.
Preferred Qualifications
- Experience applying risk-based approaches to validation.
- Experience with computerized systems validation and 21 CFR Part 11.
- Knowledge of 21 CFR Parts 210 and 211 and relevant industry guidance.
- Experience supporting global regulatory expectations and inspections.
- Knowledge of Quality by Design (QbD) principles and relevant ICH guidance.
- Lean or Six Sigma experience, particularly using structured problem solving, statistical analysis, and risk-management tools.
- Experience supporting significant capital projects, site expansions, equipment installations, or manufacturing turnarounds.
- Demonstrated experience improving or modernizing validation programs and systems.
Reason to join US
Much more than a Competitive salary,
We offer continued personal development. When you join Guerbet, you :
- Are choosing a global leader with recognized expertise in diagnostic and interventional imaging,
- Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient’s life all over the world,
- Are joining a company where we value diversity of talents coming from various horizon.
We # Innovate # Cooperate # Care #Achieve at Guerbet.
Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.
Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to careers@guerbet.com or you can also call this number +19843443717