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Validation Specialist
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Unither Pharmaceuticals
Rochester, NY (In Person)
Full-Time
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Job Description
Validation Specialist Unither Pharmaceuticals - 3.2 Rochester, NY Job Details $60,000 - $750,000 a year 9 hours ago Benefits Wellness program Health savings account 401(k) 6% Match 401(k) matching Qualifications Data-driven problem-solving Full Job Description 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. 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. ________________________________________ 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. Your profile Education and Experience 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. ________________________________________ Knowledge, Skills, and Abilities 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. ________________________________________ Scope of Responsibility Exercises judgment within defined procedures and regulatory frameworks to resolve routine validation and compliance issues. Supports planning and execution of validation activities across multiple projects or systems. May provide project-level guidance or coordination to peers or cross-functional contributors. ________________________________________ Working Relationships Regular interaction with internal departments including Operations, Engineering, Quality Assurance, Quality Control, and Technical Services. Occasional interaction with external vendors, contractors, and regulatory representatives as needed. ________________________________________ Work Environment & Physical Requirements Work is performed in both office and manufacturing environments, including controlled/cleanroom areas. Requires the ability to sit, stand, walk, and use a computer for extended periods. Must be able to wear required personal protective equipment (PPE), including safety glasses and other protective gear as applicable. May require the ability to lift, carry, and transport materials or samples within the facility. Ability to enter controlled manufacturing environments and comply with gowning and hygiene requirements. Reasonable accommodations will be provided to enable individuals with disabilities to perform the essential functions of the position, consistent with applicable law. Compensation range 60,000.00 - 750,000.00 USD The referenced compensation range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations. A Smarter Total Compensation Package At Unither, your base salary is just the beginning.