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About the Role

The Validation Specialist supports and executes 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, ensuring all activities comply with cGMP, regulatory requirements, and internal procedures.

Responsibilities

• Develops protocols for process validation, sterile processes, and 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.
• Supports change control activities and ensures validation impact assessments are completed appropriately.
• Implements assigned CAPA (Corrective Actions & Preventive Actions) 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.

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.
• 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.
• 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 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.

Skills

• Validation
• Qualification
• cGMP
• Regulatory Compliance
• Process Validation
• Sterile Processes
• Cleaning Validation
• IQ/OQ/PQ
• Data Analysis
• Root Cause Analysis
• CAPA
• Change Control
• Technical Writing
• Project Management
• Problem-Solving
• Communication

Location

• Rochester, NY

Work Type

• Onsite
• Full-time

Experience Level

• 0-2 years with Bachelor's degree
• 3+ years with Associate degree

Education Level

• Bachelor's degree in engineering, Life Sciences, or related technical discipline
• Associate degree

Salary/Compensations

• $60,000.00 - $75,000.00 USD

Benefits

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

About the Company

• French pharmaceutical industrial group focused on making healthcare solutions accessible.
• World leader in sterile single dose with 10 sites on 4 continents and over 2400 employees.
• Unither Manufacturing LLC. in Rochester (NY) specializes in Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules, with over 360 employees.
• Dynamic company driven by a spirit of victory, pursuing strong growth while maintaining close relationships with customers and employees.
• Culture based on 5 values: Respect, Responsibility, Trust, Courage and Innovation.
• Committed to providing employees with autonomy, encouraging initiatives, and offering working conditions conducive to development and potential expression.
• Site values the meaning of work and entrusts employees with a high level of responsibility.

Equal Opportunity

• Unither is an Equal Opportunity Employer.
• Committed to providing reasonable accommodations for qualified individuals with disabilities.
• Ensuring equal employment opportunity for all applicants.