Validation Specialist

Validation Specialist

Since 2013, 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.

Position Summary

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.

Essential Duties and Responsibilities

Validation Execution & Compliance

• Develops the protocols in your functional area (process validation, sterile processes, cleaning validation)
• Executes, and supports equipment and process qualification and validation protocols (e.g., IQ/OQ/PQ) for manufacturing, packaging, and facility systems.
• Ensures validation activities are appropriately scoped, planned, and executed within project timelines, including resource and documentation requirements.
• Performs sampling of in-process materials and environmental/cleaning verification (e.g., surface swabbing) in accordance with approved protocols.
• Analyzes validation data using appropriate statistical and scientific methods to assess process capability and compliance.
• Reviews and compiles supporting documentation (e.g., batch records, certificates of analysis, equipment logs).
• Investigates deviations and exceptions, contributes to root cause analysis, and supports implementation of corrective and preventive actions (CAPA).
• Determines and documents validation conclusions based on data, observations, and investigation outcomes.
• Collaborates cross-functionally with Operations, Engineering, Quality Assurance, Quality Control, and Technical Services to ensure alignment and compliance.

Documentation & Reporting

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

Continuous Improvement & Compliance Enhancement

• Maintains current knowledge of regulatory expectations (e.g., FDA, cGMP) and industry best practices.
• Evaluates existing validation and operational processes; identifies and implements improvements to enhance efficiency, quality, and compliance and improves procedures consequently.
• Supports change control activities and ensures validation impact assessments are completed appropriately.
• Implements the CAPA (Corrective Actions & Preventive Actions) assigned to you, and supports site CAPA implementation.
• Promotes the effective use of technology and systems to improve validation processes.
• Provides training and guidance to stakeholders on validation processes and procedural updates.

We are committed to bringing these values to life with our employees by granting them a high degree of autonomy in the exercise of their profession and by encouraging their initiatives.

We are committed to providing them with working conditions and atmosphere that is conducive to their development and the expression of their potential.

Unither is an Equal Opportunity Employer. We are committed to providing reasonable accommodations for qualified individuals with disabilities and to ensuring equal employment opportunity for all applicants.