Validation Engineer

Fresenius Kabi USA, LLC; Town of Grand Island (NY); On-site; USD 61,000 - 86,000; Full time

Job summary

Fresenius Kabi USA, LLC in New York is seeking a Validation Specialist to validate and revalidate products, equipment and systems, and to provide technical support to Operations.

This role conducts equipment qualification studies, analyzes data, prepares final reports, and participates in deviations and CAPA processes, ensuring cGMP compliance and readiness for regulatory filings as needed.

Qualifications

• BS/BA degree in science, engineering, manufacturing technology or closely related field
• 1–3 years pharmaceutical manufacturing experience
• Excellent attention to detail
• Proactive with strong teamwork and interpersonal skills
• Ability to write clear reports and basic statistical analysis
• PC literate with standard office applications (Word, Excel, PowerPoint) and knowledge of cGMPs

Responsibilities

• Performs equipment requalifications per SOPs and communicates results to affected groups
• Executes equipment validation studies from protocol through Final Report
• Programs and operates analytical instruments for chamber qualifications/requalifications
• Participates in improvement of validation programs and regulatory compliance
• Participates in deviation investigations and CAPA actions
• Conducts HEPA/critical area testing and records results
• Participates in presentations to Regulatory Agencies when needed
• Contributes to equipment improvement teams to enhance compliance and performance

Skills

Attention to detail

Proactive

Teamwork

Interpersonal skills

Self-management

Report writing

Data analysis

Office software

Education

BS/BA in science/engineering

Tools

Office suite (Word, Excel, PowerPoint)

Job description

Job Summary

Validates and revalidates new or modified products, equipment or systems. Provides technical support to Operations in terms of equipment/system initial validation and equipment/system requalifications.

Salary Range: $60,966-$85,694 annually

Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

Responsibilities

• Performs equipment requalifications per Standard Operating Procedures (SOPs). Coordinates and communicates all testing with affected functional groups and evaluates test results. Analyzes data, composes a Final Report and circulates for approval.
• Executes equipment validation studies per SOPs or utilizing reference templates, to include protocol preparation, scheduling, protocol execution, data analysis, Final Report preparation and circulation for approval.
• Programs and operates department analytical instruments (such as temperature/humidity dataloggers and thermocouples) to perform controlled temperature/humidity chamber qualifications/requalifications (i.e.: lyophilizers, sterilizers, depyrogenation ovens/tunnels, warehouses, coolers/freezers, incubators, etc.).
• Participates in improvements to validation programs/procedures as needed to remain current with cGMPs and industry standards.
• Participates in teams assembled to validate and maintain systems and equipment.
• Participates in deviation investigations and corrective and/or preventative actions (CA/PA).
• Performs HEPA Filter integrity/velocity testing and participates in Critical Area (Class 100) airflow pattern testing. Programs and operates test equipment such as smoke generators, photometers, velocity meters, etc., and accurately records and evaluates results.
• Participates in presentation for Regulatory Agency(s) when necessary.
• Participates in equipment improvement teams charged with enhancing the compliance and performance of plant systems, while considering the regulatory requirements for change control.

Requirements

• BS/BA degree in science, engineering, manufacturing technology or closely related field, or equivalent experience in a manufacturing facility.
• 1 - 3 years pharmaceutical manufacturing experience.
• Excellent attention to detail.
• Must be proactive, ability to work in high performance teams, strong interpersonal and self-management skills.
• Must be able to interact with varying levels within the company.
• Ability to work both independently and in partnership with others; ability to use initiative and drive to achieve results.
• Ability to write reports, deviations or other technical documents clearly, concisely, and accurately; accurately record data and a basic understanding of statistical analysis.
• PC literate with standard office application (Word, Excel, PowerPoint, Project, Access) competency.
• Knowledge and understanding of cGMPs, industry guidance, and aseptic techniques.
• The Company's primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is atwill, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.