Validation Specialist

Unither • Rochester, NY

2d • Hybrid

About The Position

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. Your role Reporting to the Validation Manager, 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.

Requirements

• Bachelor’s degree in engineering, Life Sciences, or a related technical discipline in FDA regulated environment preferred.
• Associates 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 is preferred.
• Working knowledge of cGMP regulations and validation lifecycle principles.
• Understanding of FDA and regulatory expectations for validation and compliance.
• Strong analytical and problem-solving skills with the ability to interpret technical data.
• Effective written and verbal communication skills across technical and cross-functional teams.
• Ability to manage multiple projects simultaneously and adapt to shifting priorities and timelines.
• Knowledge of manufacturing processes, equipment, and critical utilities is preferred.
• Proficiency with documentation systems and standard office software tools.

Responsibilities

• 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.
• 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.
• 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.

Benefits

• 100% employer-paid medical premiums
• 401(k) contributions: 6% match plus an additional 4% company-funded contribution
• HSA contributions with wellness incentives
• Annual performance bonuses and merit increase eligibility

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level