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.
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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.
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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.
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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.
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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.
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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.
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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.
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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 - 75 000,00 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. Our Total Rewards include:
It’s a package designed to reward impact—not just hours worked.
More Than Just a Paycheck
At Unither, we don’t just offer competitive hourly wages—we also pay 100% of your medical premiums. That means no paycheck deductions for your healthcare, which can be worth an extra $1 to $3.50 an hour in your pocket compared to jobs where you pay part of the premium.
Learn more about us:
We are a dynamic company driven by a spirit of victory and are therefore pursuing strong growth while maintaining a close relationship with our customers and employees.
Our culture is based on 5 values: Respect, Responsibility, Trust, Courage and Innovation. 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.
We propose you to integrate a site that values the meaning of work and that entrusts our employees with a high level of responsibility.
Join us and make a difference!
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.
Unither Pharmaceuticals, with 8 manufacturing plants (France, USA, Brazil and China) 4 commercial offices and 1 R&D platform, is the worldwide leader in sterile unit-doses contract manufacturing. Unither Pharmaceuticals manufactures several product lines, using highly innovative and competitive niche technologies such as: Liquid Stick-Pack, Sterile unit-dose (Blow Fill & Seal Technology), Multidoses with and without preservative, Pharmaceuticals bottles, Suppositories and Pessaries, etc. Our products are sold in more than 100 countries for an annual turnover of 371 million euros. Our vision is to be recognized for making affordable healthcare solutions that improve and simplify patients’ lives for as many people as possible. Our mission is to deliver innovative, competitive and sustainable solutions to our customers: pharmaceutical companies. Our promise is to consider patients’ needs in order to make successful products for our pharmaceutical customers.
