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Validation Department Jobs (NOW HIRING)

Laboratoire Guerbet

Mgr Quality Validation

Raleigh, IL · On-site

Responsible for the day-to-day activities conducted by the Validation department. * Provide leadership on the activities of the internal validation staff as well as external validation contractors.

INCOG

Senior Validation Engineer

Fishers, IN · On-site

The Senior Validation Engineer is a key individual contributor role within the INCOG BioPharma Validation Department. The Senior Validation Engineer is responsible for understanding and implementing ...

adareps

Validation Engineer

Vandalia, OH

Provide technical training and support to departments supported by the Technical Services/Validation departments (Third party GSC, Manufacturing, etc). * Update, review, and approve Standard ...

Adare Pharma

Validation Engineer

Vandalia, OH · On-site

Provide technical training and support to departments supported by the Technical Services/Validation departments (Third party GSC, Manufacturing, etc). * Update, review, and approve Standard ...

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How much do validation department jobs pay per hour?

As of Aug 23, 2026, the average hourly pay for validation department in the United States is $52.00, according to ZipRecruiter salary data. Most workers in this role earn between $39.42 and $63.22 per hour, depending on experience, location, and employer.

What is the difference between Validation Department vs Quality Assurance Specialist?

AspectValidation DepartmentQuality Assurance Specialist
CredentialsRelevant certifications like GxP, ISO, or industry-specific validation trainingCertifications such as ASQ CQE, Six Sigma, or ISO auditor
Work EnvironmentLaboratories, manufacturing plants, regulated industriesQuality departments, manufacturing facilities, service industries
Employer & Industry UsagePharmaceuticals, biotech, medical devices, regulated manufacturingManufacturing, healthcare, software, and service sectors
Common Search & ComparisonValidation DepartmentQuality Assurance Specialist

The Validation Department primarily focuses on qualifying and validating processes, equipment, and systems to ensure compliance with industry standards. Quality Assurance Specialists oversee overall quality processes, audits, and compliance. While both roles aim to ensure product quality and regulatory adherence, Validation Departments are more technical and process-specific, whereas Quality Assurance Specialists have a broader scope in quality management.

What does a validation department do?

A validation department is responsible for ensuring that processes, equipment, and systems meet specified standards and regulatory requirements. They develop and execute validation protocols, document results, and maintain compliance to ensure product quality and safety, often using tools like validation software and following industry guidelines such as GMP or ISO standards.

What is a validation department job?

A validation department job involves ensuring that processes, equipment, and systems meet specified standards and regulatory requirements. Roles typically include developing validation protocols, performing tests, and documenting results to confirm compliance, often requiring knowledge of Good Manufacturing Practices (GMP) and validation tools. These jobs are common in industries like pharmaceuticals, biotech, and manufacturing.
More about Validation Department jobs

What job categories do people searching Validation Department jobs look for?

The top searched job categories for Validation Department jobs are:

Infographic showing various Validation Department job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 79% Full Time, 16% Part Time, 3% Contract, and 1% Nights. Highlights an 97% Physical, 1% Hybrid, and 2% Remote job distribution, with an average salary of $108,152 per year, or $52 per hour.

Mgr Quality Validation

Laboratoire Guerbet

Raleigh, IL • On-site

Full-time

Re-posted 8 days ago

Job description

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
Lead the Validation Team to provide excellent service to customers and ensure compliance to cGMP FDA/EMEA regulations. Serve as a Validation subject matter expert, track, and report action plan status/ completion as it relates to validation systems improvement efforts. Responsible for managing the development and the execution of qualifications, validations, re-qualifications and re-validations for process and laboratory equipment, computer systems, utilities, facilities, manufacturing, and cleaning processes.
Support ongoing site wide projects by collaborating with experienced members of the Engineering, MS&T, Operations and QA teams to identify roadblocks and additional efficiencies. Additional daily responsibilities include performing and documenting risk assessments of systems and processes, assessing change proposals, drafting/reviewing/approving protocols, and reports, evaluating deviations/change controls and initiating revisions of GMP documentation related to validation.
YOUR ROLE
Essential Functions
  • Responsible for the day-to-day activities conducted by the Validation department.
  • Provide leadership on the activities of the internal validation staff as well as external validation contractors.
  • Lead team member assignments to assure tasks are completed accurately and to schedule.
  • Establish priorities to ensure that deadlines are met, and budgets are not exceeded.
  • Oversee the site Validation Master Plan, using input from internal and external resources for continuous improvement.
  • Create, coordinate, maintain and enforce Validation systems, policies, and procedures.
  • Participate in audits and inspections conducted by internal and external entities.
  • Able to correctly assess all change controls with an accurate understanding of the bigger picture implications of changes
  • Review and approve all business unit validation testing and documents for completeness and accuracy, sound rationale, compliance with validation policies and procedures, and accurate data.
  • Ensure all revalidation requirements are met for equipment, process, and cleaning site wide.
  • Manage the revalidation program.
  • Team member for new product introductions, regulatory compliance initiatives, implementation of process improvements.
  • Forecast and manage project work correctly and independently; able to be an independent interface to other portions of the organization as assigned, providing updates as requested and seeking out higher level input when it is necessary; scope of projects managed is large and complex.
  • Write and review policies or procedures for compliance with regulatory guidance.
  • Active leader and decision maker, as needed, on internal projects related to formulation, filling, environmental, facility improvements and developing new approach to business.
  • Work with Regulatory Affairs to prepare Regulatory Submission Documents for project initiatives.
  • Lead initiatives to streamline processes and workflow by initiating Operational Excellence initiatives.
  • Interact with management, senior management, and stakeholders to determine project scopes, timelines, and prioritization of global and local projects.
  • Manage validation activities for large scope capital projects (including Turnaround projects) that encompass multiple protocols and/or a validation plan.
  • Direct supervision of contractors or other specialists.

Key Requirements
  • Thorough knowledge of validation life cycle, validation protocols (IQ/OQ/PQ) generation and execution of manufacturing and laboratory equipment, clean process utilities, classified facilities, cleaning, and Process Validations.
  • Thorough knowledge of the of steam sterilization, cleaning and process validation and equipment qualification.
  • Strong leadership skills, the ability to prioritize, multitask and work efficiently in a dynamic, ever changing manufacturing environment.
  • Perform administrative duties associated with managing a department and staff. (i.e. establish group goals, and performance reviews).
  • Strong coaching and mentoring skills and a track record of developing direct reports.
  • Identify quality issues, and in conjunction with site Quality Manager, recommend and implement corrective and preventative actions.
  • Good communication with multiple individuals, departments, contractors, auditors and strong organizational skills.
  • Knowledge of cGMP, cGLP, cGXP, FDA, ICH, EMEA and 21 CFR 11 regulations, guidelines, policies and procedures for parenteral/injectable products.
  • Proactively manage and maintain regulatory compliance (US/EU/WHO/Brazilian/Korean standards).
  • Knowledge of agency and vendor audits.
  • Able to respond/react with appropriate urgency/ professionalism and make decision under pressure.
  • Support goals and initiatives tied to Guerbet Plan and department goals.
  • Evaluate current systems and process to determine upgrades, additional technology and improve as needed.

Department Specific/ Non-Essential Functions:
  • Enforce EHS procedures and respond to EHS concerns within his/her area of operational responsibility. Perform incident investigations and follow through regarding corrective actions.
  • Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment. Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk. Report all safety and/or environmental incidents to management immediately.
  • Other duties as assigned with or without accommodation.

YOUR BACKGROUND
Preferred Skills/ Qualifications:
  • Knowledge and application of Risk Based approaches to Validation.
  • Able to balance, resources, voice of the customer and timelines, while implementing robust and defendable validation strategies.
  • Ability to work independently in a fast-paced environment and manage multiple project and priorities.
  • Candidate should possess experience in equipment C&Q, cleaning, sterilization, and process validation.
  • Demonstrated expertise in Six Sigma and Lean projects that utilized the concepts and tools for problem definition, root cause analysis, risk assessment, process development, and statistical analysis.
  • Strong knowledge of ICH guidelines and QBD principles applicable to a manufacturing environment, with successful application experience.
  • Industry guideline knowledge of 21 CFR part 11, 21 CFR part 210, 21 CFR part 211, IPSE, PDA, MHRA, PICs, MFDS.
  • Validation experience, verbal and written communications, ability to manage multiple tasks.
  • Strong team member with demonstrated ability to work collaboratively with others.
  • Candidate must possess personal drive and the ability to schedule work assignments so that they are concluded in a timely, complete, and error-free manner with the highest level of accountability.
  • Proficient and effective communication with both team members and other plant support groups.
  • Planning, organization, leadership, teamwork.

Education and Experience:
  • BS degree in engineering/ life sciences.
  • 10 years of validation experience in a pharmaceutical environment.
  • 8 years supervisory experience.
  • Relevant experience with industry process validation requirements and expectations.
  • Working knowledge of the science and technology for the major unit operations associated with parenteral/ injectable manufacturing/ packaging operations.
  • Experience with troubleshooting/ problem-solving and risk assessment/ mitigation

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

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