Unither Pharmaceuticals · 4 days ago
Computer Systems Validation Specialist
Rochester, NY
Full-time
Onsite
Mid Level
$65K/yr - $75K/yr
3+ years expUnither Pharmaceuticals is a French pharmaceutical industrial group recognized for making affordable healthcare products. The Computer Systems Validation Specialist will coordinate validation activities related to computer systems, ensuring compliance with FDA regulations and maintaining the validated state of systems.
BiotechnologyManufacturingPharmaceutical
Responsibilities
Reviews and aids in developing applicable User Requirement Specifications, Functional and Design Specifications
Generates validation project plans detailing responsibilities along with the required actions to validate a system
Collaborating with the impacted departments to develop risk assessments which include identifying the necessary controls and mitigation methods
Develops, writes, and executes qualification protocols ensuring FDA 21 CFR part 11 and Annex 11 compliance as well as system and user acceptance testing is consistently met along with generating all summary reports
Contemporaneously compiles and organizes all qualification documentation including the initial specification documents, approved protocol(s), executed test scripts, screen snips, outputs, along with the approved report(s) within the appropriate project folder throughout the process of validating a system
Develop a standard operating procedure specific to validating computer systems including how hardware and firmware updates as well as software version changes will be addressed to verify systems remain in a validated state
Develops and executes equipment qualification protocols for manufacturing, processing, and packaging equipment and facilities supporting these operations
Ensures appropriate validation activities are included in site or team project plans: including tasks, work force requirements, and duration
Obtains copies and compiles relevant documentation such as executed batch records, certificates of analysis, equipment logs, materials certificates, and completed controlled forms
Investigates and assists in resolving deviations/ exceptions from the predefined acceptance criteria
Draws conclusions from data, observations, deviations and investigation as to whether a process is considered valid
Interacts with and coordinates compliance efforts with other departments including, but not limited to: Information Technology, Operations, Engineering, Quality Assurance, and Product Development to provide a high degree of assurance that all qualification/validation activities, where appropriate, are completed
Writes validation protocols (process validations for, manufacturing and packaging processes
Writes final reports for validation protocols following criteria as outlined within the validation procedures and policies
Performs proper and timely sampling of in-process/intermediate products and surface swabbing for testing as outlined by validation/recertification protocols
Obtains and reviews test results and verifies results as passing
Maintains protocols, test results, and system documentation in an orderly library so that information can be provided to regulatory bodies in a timely manner
Ensures protocols, verifications, and reports generated during validation activities are maintained according to procedure
Keeps abreast of industry current practices
Modifies validation protocols and procedures to align with industry
Qualification
Required
Bachelor's degree in a science or engineering discipline preferred. An associate degree with relevant experience will be considered
For candidates with an Associate's degree: Minimum 3 years of relevant experience in validation, GMP, or a regulated environment required. Co-op/internship experience preferred
Worked in IT or OT Department
In addition to the educational and/or experience in lieu of bachelor's degree; 0-2 years of relevant work experience is required
Stay abreast of changes in cGMP trends for validation and industry standards
Effectively communicate, both written and oral, validation requirements and policies to a diverse group of technical personnel
Ability to manage multiple projects in different phases of project completion, at varying times
The ability to read, write, and communicate in English, as needed
Motivate and challenge internal and external personnel to maintain a high level of customer service and system compliance
Ability to effectively change and adapt project scope creep and change in timelines
Understanding of FDA requirements for validation
The ability to analyze and interpret data
In depth understanding and knowledge of successfully validating a computer system to meet all FDA and Annex11 requirements
Preferred
Co-op/internship experience preferred
Benefits
100% employer-paid medical premiums (a $2,000–$6,000+ annual value)
401(k) contributions: 6% match plus an additional 4% company-funded contribution
HSA contributions with wellness incentives
Company
Unither Pharmaceuticals
Unither Pharmaceuticals is a French manufacturer of dosage forms for pharmaceutical laboratories and generic products.
1001-5000 employees
H1B Sponsorship
Unither Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2022 (1)
Funding
Current Stage
Late StageTotal Funding
unknown2022-10-26Private Equity
2017-03-08Private Equity
2016-11-18Acquired
Leadership Team
Constance Sellman
CFO & IT Director
Recent News
2025-12-08
Company data provided by crunchbase