Validation Engineer

Fresenius Kabi USA; Town of Grand Island (NY); Sur place; USD 63 000 - 85 000; Plein temps

Avantages offerts par ce poste

401(k) plan

Health benefits

Dental coverage

Vision coverage

Paid vacation

Life insurance

Disability

Wellness program

Résumé du poste

Fresenius Kabi USA is seeking a detail‑oriented professional to validate and revalidate new or modified products, equipment, or systems. You will support Operations with equipment initial validation and requalification, and coordinate testing across functional teams, documenting findings and Final Reports.

The role requires a BS/BA in science or engineering and 1–3 years of pharmaceutical manufacturing experience, with strong data analysis, technical writing, and teamwork skills.

Qualifications

• BS/BA in science, engineering, or closely related field.
• 1–3 years pharmaceutical manufacturing experience.
• Strong attention to detail and ability to work in cross-functional teams.

Responsabilités

• Perform equipment requalifications per SOPs and communicate results to affected groups.
• Execute equipment validation studies including protocol prep, execution, data analysis and Final Report circulation.
• Operate and program analytical instruments and data loggers for chamber qualifications/requalifications.
• Participate in deviations investigations and CAPA activities; support change control.
• Assist in improvements to validation programs to stay current with cGMPs and industry standards.

Connaissances

Pharma manufacturing

cGMPs knowledge

Data analysis

Technical writing

Team collaboration

Formation

BS/BA in science or engineering

Outils

Data analysis software

Description du poste

Job SummaryValidates 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: $63,000 - $$85,000 AnnuallyFinal pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.Our benefits programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.ResponsibilitiesPerforms 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.All employees are responsible for:a) Protecting the environmentb) Preventing pollutionc) Complying with applicable requirements as identified in the policy statementsd) Promoting sustainable practicese) Working in accordance with the documented environmental procedures and policies, specific responsibilities definedf) Reporting problems or deviations associated with environmental issues and the EMS to the EMRResponsibilitiesBS/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.Additional InformationWe 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.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.