Description

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.

Primary 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.

Education & Experience

Required Qualifications: 

• 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.

Knowledge, Skills & Abilities

• 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.

Why Join bioMérieux?

At bioMérieux, you'll work alongside dedicated professionals committed to advancing public health through innovation. We offer opportunities to develop your career in a collaborative, mission-driven environment where your contributions have a meaningful impact on patients around the world.

Physical Demands & Working Conditions

• Combination of office, laboratory, and manufacturing environments.
• Ability to stand, sit, walk, climb stairs, and access manufacturing areas as needed.
• Use of required personal protective equipment (PPE) while in production and laboratory environments.Occasional domestic and international travel may be required.

The estimated salary range for this role based in Illinois is between $91,300 – $116,700. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux’s bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate’s experience and will be presented in writing at the time of the offer. 

In addition, bioMérieux offers a competitive Total Rewards package that may include: 

·        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

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BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).