sr validation engineer - Melrose Park, United States - Fresenius Kabi AG

Description

Job Summary

Responsible for providing technical support to operations in terms of initial equipment/facility/utility qualifications and equipment/facility/utility requalifications. Will participate in process and equipment improvement teams charged with enhancing the compliance and performance of plant systems, while considering the regulatory requirements for change control. Individual must display a solid technical understanding of validation principles. The individual must be able to lead validation projects showing proficiency in project and time management skills. The ability to write reports clearly, concisely and accurately; accurately record data and a basic understanding of statistical analysis is also required to perform these duties. Weekends and Off-shift hours are periodically required.

Responsibilities

ESSENTIAL JOB FUNCTIONS

• Independently plan, perform and document validation activities (IQ, OQ, PQ) for new and existing equipment, facilities and utilities in a pharmaceutical manufacturing environment
• Create validation schedules, coordinate execution efforts with contractors, production operators, manufacturing engineers and quality assurance personnel
• Track and communicate progress of work against milestones
• Compose validation plans, protocols, traceability matrices, risk assessments and final report summaries
• Develops/improves validation programs as needed to remain current with cGMPs and industry standards.
• Represents Validation in teams assembled to specify, install, validate, troubleshoot and maintain systems, equipment and processes.
• Conduct and/or participate in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).
• Responsible for maintaining and constant improvement of the ISO 50001 energy management system.
• Identify energy savings opportunities and make recommendations to achieve more energy efficient operation. Monitor and analyze energy consumption.
• All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities

JOB REQUIREMENTS

• Bachelor degree in Engineering or a Scientific Field required

• Minimum of 3 years relevant experience in a cGMP facility; pharmaceutical industry experience preferred

• Proficient in generating reports, technical writing/reviewing skills and other technical documents required

• Knowledge and understanding of cGMPs, industry guidance and aseptic techniques needed

PC literate with Microsoft Office proficiency

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 match, and wellness program.

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.