Validation Specialist

Who we Are

As a French pharmaceutical industrial group, we strive to make healthcare solutions that improve and simplify patients' lives accessible to as many people as possible. As a world leader in sterile single dose, we have 10 sites on 4 continents and more than 2400 employees. Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules.

It has more than 360 employees.

Reporting to the Validation Manager, the Validation Specialist is responsible for supporting and executing validation and qualification activities for manufacturing processes, equipment, utilities, and facilities in a regulated environment. This role manages validation projects or discrete project components with limited supervision and ensures all activities are conducted in accordance with current Good Manufacturing Practices (cGMP), applicable regulatory requirements, and internal procedures.

The Validation Specialist handles validation execution, documentation, continuous improvement, and cross-functional collaboration to ensure compliance and efficiency within the manufacturing operations.

• Develop protocols in functional areas such as process validation, sterile processes, and cleaning validation.
• Execute and support equipment and process qualification and validation protocols (e.g., IQ/OQ/PQ) for manufacturing, packaging, and facility systems.
• Ensure validation activities are scoped, planned, and executed within project timelines, including resource and documentation requirements.
• Perform sampling of in-process materials and environmental/cleaning verification in accordance with approved protocols.
• Analyze validation data using appropriate statistical and scientific methods to assess process capability and compliance.
• Review and compile supporting documentation such as batch records, certificates of analysis, and equipment logs.
• Investigate deviations and exceptions, contribute to root cause analysis, and support implementation of corrective and preventive actions (CAPA).
• Determine and document validation conclusions based on data, observations, and investigation outcomes.
• Collaborate cross‑functionally with Operations, Engineering, Quality Assurance, Quality Control, and Technical Services to ensure alignment and compliance.

• Author validation protocols, reports, and supporting documentation for facilities, equipment, utilities, cleaning processes, and manufacturing operations.
• Prepare summary and closeout reports in accordance with internal procedures and regulatory expectations.
• Maintain validation documentation in an organized and inspection‑ready state to support internal audits and regulatory inspections.
• Ensure all validation deliverables are completed, reviewed, and archived in compliance with document control procedures.

• Maintain current knowledge of regulatory expectations and industry best practices.
• Evaluate existing validation and operational processes, identify and implement improvements to enhance efficiency, quality, and compliance.
• Support change control activities and ensure validation impact assessments are completed appropriately.
• Implement assigned CAPA and support site CAPA implementation.
• Promote the effective use of technology and systems to improve validation processes.
• Provide training and guidance to stakeholders on validation processes and procedural updates.

• Bachelor’s degree in engineering, life sciences, or a related technical discipline in an FDA‑regulated environment preferred.
• Associate’s degree with relevant industry experience may be considered.
• 0–2 years of relevant experience with a bachelor’s degree; or 3+ years of validation, cGMP, or regulated industry experience with an associate degree.
• Internship or co‑op experience in a regulated environment preferred.

• Working knowledge of cGMP regulations and validation lifecycle principles.
• Understanding of FDA and regulatory…