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 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.

Your profile

EDUCATION & EXPERIENCE:

• 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.

KNOWLEDGE SKILLS & ABILITIES:
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.
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.

SCOPE OF DECISION-MAKING: Decisions require basic/routine analytical judgment. Plan and perform diversified duties requiring knowledge of a particular field and the use of a wide range of procedures. Involves the exercise of judgment in the analysis of facts or conditions regarding individual problems or transactions to determine what action should be taken within the guidelines or standard practice.

LEVEL OF SUPERVISION PROVIDED: Project direction of other employees performing the same or directly related work, including assigning, reviewing, checking work, eliminating ordinary supervisory/management positions.

INTERNAL / EXTERNAL CONTACTS: Regular inside and outside the organization: Requires regular contact with subordinates and/or other departments, with occasional contacts with individuals outside the organization. Also includes jobs with regular customer/client contacts.

PHYSICAL REQUIREMENTS/ENVIRONMENT:
Traditional office environment, with frequent visits to other areas of the facility.
Must be able to work on a computer for extended periods of time.
Must wear safety glasses and other protective items as required.
Sitting 75% of the day; standing or walking 25%.
Ability to gown and enter controlled manufacturing areas.
Ability to collect and transport validation samples.
Frequently subjected to project deadlines.

Compensation range

65,000.00 - 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.

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!