Validation Engineer

301044 Fresenius Kabi USA, LLC; Town of Grand Island (NY); On-site; USD 61,000 - 86,000; Full time

Benefits offered by this job

Medical coverage

Dental and Vision

401K with company contribution

Job summary

Fresenius Kabi USA, LLC seeks a validation professional to verify and revalidate pharmaceutical systems and equipment. You will support operations with initial validation, equipment requalifications, and data-driven Final Reports.

Responsibilities include SOP-based studies, instrument programming, and cross-functional collaboration to ensure regulatory compliance and quality. Strong analytical and communication skills are essential, with 1–3 years in pharma manufacturing.

Qualifications

• BS/BA in science, engineering, manufacturing tech, or equivalent experience.
• 1–3 years pharmaceutical manufacturing experience.
• Excellent attention to detail and proactive work style.
• Able to work independently and in teams; strong communication and self-management.
• Knowledge of cGMPs, aseptic techniques and regulatory expectations.

Responsibilities

• Perform equipment requalifications per SOPs and document results.
• Coordinate testing with affected groups and evaluate results.
• Analyze data; draft Final Reports and obtain approvals.
• Execute validation studies per SOPs; prepare protocols and reports.
• Operate instruments (dataloggers, thermocouples) for chamber qualifications.
• Suggest improvements to validation programs to stay compliant.
• Participate in teams to validate and maintain systems/equipment.
• Contribute to deviation investigations and CAPA actions.
• Conduct HEPA tests and airflow pattern checks where applicable.
• Operate test equipment (smoke generators, photometers, velocity meters).
• Present findings to Regulatory Agencies when required.
• Join equipment-improvement groups to enhance performance and compliance.

Skills

Attention to detail

Teamwork

Self-management

Report writing

Analytical thinking

Interpersonal skills

Cross-level communication

Education

BS/BA in science/engineering/manufacturing

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Microsoft Project

Microsoft Access

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, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at-will, 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.

Equal Opportunity

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.

About Fresenius Kabi

Fresenius Kabi is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. With more than 41,000 employees worldwide, our dedicated team is united by our shared purpose: to put lifesaving medicines and technologies in the hands of people who care for patients - and to find answers to the challenges they face. We call this purpose caring for life. Our U.S. headquarters is in Lake Zurich, Illinois and the company’s global headquarters is in Bad Homburg, Germany.

Follow us on LinkedIn to learn more: http://bit.ly/3KdaGJr