Computer Systems Validation Specialist

Computer Systems Validation Specialist

Who we are?

We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify patients' lives to as many people as possible.

With 30 years of technological expertise, we position ourselves as a world leader in sterile single dose with 10 sites on 4 continents and more than 2000 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 280 employees.

Your role

Reporting to the Quality Director,

JOB SUMMARY:

This is a team-oriented position with the individual actively coordinating, working, and communicating with personnel across multiple departments. Performs validation activities related to the implementation of computer systems as well as verifying the systems are being maintained in a validated state. Generates applicable validation project plans and risk assessments. Responsibilities will also include other qualification and validation activities such as but not limited to equipment qualifications, utility recertifications, cleaning recertifications, and recertification of sterile processes.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

Computer Systems Validation Activities (50%)

Reviews and aids in developing applicable User Requirement Specifications, Functional and Design Specifications. If completed by an external company, the computer systems validation (CSV) specialist will be responsible for obtaining these documents prior to developing the validation project plan and qualification protocols.

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.

Qualification Protocols and Documentation (30%)

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.

Validation Protocols and Documentation (200%)

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…