Validation Specialist 2

bioMérieux•Lombard, IL

7d•$91,300 - $116,700•Hybrid

About The Position

The Validation Specialist II is responsible for developing, implementing, and maintaining validation programs that ensure manufacturing processes, equipment, software systems, controlled environments, and cleaning processes remain compliant with regulatory requirements and company standards. This role independently plans and executes validation activities, supports continuous improvement initiatives, and collaborates cross-functionally to maintain a validated state across manufacturing and support operations.

Requirements

Bachelor's degree in Engineering, Life Sciences, or Biomedical Sciences.
Minimum of two years of experience in validation within a cGMP-regulated manufacturing environment with hands-on experience with equipment, process, software, environmental, or cleaning validation activities and experience developing validation documentation, protocols, reports, and risk assessments.
Strong understanding of validation lifecycle principles and regulatory compliance requirements.
Knowledge of cGMP, FDA, ISO 13485, and computerized system validation requirements.
Excellent analytical, problem-solving, and organizational skills.
Strong written and verbal communication skills.
Ability to manage multiple projects and priorities independently.
Effective collaboration and stakeholder management skills in a cross-functional environment.
Advanced proficiency with Microsoft Office applications, including Excel, Word, Outlook, and Teams.

Responsibilities

Develop and execute validation strategies for equipment, processes, software, cleaning systems, environmental controls, and products.
Lead qualification and validation activities, including IQ, OQ, PQ, process validation, software validation, re-qualification, and re-validation efforts.
Prepare, review, and approve validation protocols, reports, risk assessments, validation master plans, technical documentation, and supporting records.
Monitor validated systems and controlled environments to ensure ongoing compliance and state-of-validation maintenance.
Investigate deviations, non-conformances, and validation-related issues, implementing corrective and preventive actions as required.
Support change control activities and assess validation impact related to equipment, process, facility, or software modifications.
Partner with Engineering, Manufacturing, Quality Assurance, Quality Control, suppliers, and project teams to ensure successful project execution.
Participate in internal, external, and supplier audits, supporting audit readiness and remediation activities.
Provide training and guidance on validation requirements, standards, and best practices.
Ensure compliance with applicable regulatory requirements, including cGMP, ISO 13485, FDA 21 CFR Part 11, and GAMP guidelines.

Benefits

A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options
Company-Provided Life and Accidental Death Insurance
Short and Long-Term Disability Insurance
Retirement Plan including a generous non-discretionary employer contribution and employer match.
Adoption Assistance
Wellness Programs
Employee Assistance Program
Commuter Benefits
Various voluntary benefit offerings
Discount programs
Parental leaves