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, 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. Position Summary The Validation Specialist handles validation execution, documentation, continuous improvement, and cross-functional collaboration to ensure compliance and efficiency within the manufacturing operations. Essential Duties and Responsibilities 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. Documentation and Reporting 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. Continuous Improvement and Compliance Enhancement 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. Your Profile – Education and Experience 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. 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 Exercise judgment within defined procedures and regulatory frameworks to resolve routine validation and compliance issues. Support planning and execution of validation activities across multiple projects or systems. 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 and Physical Requirements Work performed in both office and manufacturing environments, including controlled/cleanroom areas. 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 – 75,000.00 USD per year. The referenced compensation range represents the minimum and maximum compensation for this job. Individual annual salaries will be set within the range, considering market data, education, experience, qualifications, and internal equity. Smarter Total Compensation Package 100% employer‑paid medical premiums (annual value $2,000–$6,000+). 401(k) contributions: 6% match plus additional 4% company‑funded contribution. HSA contributions with wellness incentives. Annual performance bonuses and merit increase eligibility. Additional benefits including flexible scheduling, paid time off, and professional development support. Equal Opportunity Statement 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. #J-18808-Ljbffr