Validation Engineer (Computer Systems)

301044 Fresenius Kabi USA, LLC (Melrose Park FL, USA) Follow 7 hours ago

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Job Summary THIS JOB IS A FULL-TIME ONSITE POSITION, NO CONTRACT WORK AVAILABLE. THIS JOB IS NOT ELIGIBLE FOR VISA SPONSORSHIP NOW OR IN THE FUTURE. Salary: $65,000 to $80,000 Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. Our benefits and 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. Read more about our benefits here.

Responsibilities

The Validation Engineer is specialized in computerized systems validation and knowledgeable in MES (EBR) , historian(QMIB), LAB -X and other manufacturing applications. Provides technical & documentation support for manufacturing process and associated computer systems. Also compliance knowledge on various aseptic manufacturing processes (sterilization, isolator technology, clean rooms, computerized systems, etc). Uses his/her expertise to maintain industry standards within the company. The focus of the Validation Engineer is on technical and documentation aspects of the department and typically does not have direct report. The Validation Engineer must have excellent verbal and written communication skills as this position interacts directly with multiple departments at the site, regional and global levels.

Schedules and executes computer system qualifications per Standard Operating Procedures (SOPs).
Coordinates and communicates all testing with affected functional groups and evaluates test results.
Assembles and composes the final report and circulates for approval.
Executes validation studies (utility, equipment, cleaning, process, computer, and new products) to include protocol preparation, scheduling, protocol execution, and final report preparation.
Present results to Regulatory Agency when necessary.
Participates in dry running the manufacturing system applications and develops the test scenarios, test environments, test scripts.
Develops and updates full life cycle documents includes, URS, FDS, DS, risk assessments, impact assessment, FMEAs and test and qualification protocols.
Develops/improves validation programs as needed to remain current with cGMPs and industry standards
Represents Technical Services in teams assembled to specify, install, validate, troubleshoot and maintain systems, equipment and processes.
Conducts and/or participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).
Authors validation master plans and validation project plans outlining qualification requirements.
Authors the documentation needed for MES(EBR), Historian(QMIB), manufacturing applications and infrastructure like industrial data center, etc.
Provides technical support for Investigations, Action Plans, Change Controls and Risk Assessments as required.
Generates innovative solutions to solve difficult problems that may impact multiple disciplines
Additional projects and tasks as assigned.

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’s Degree in a Science or Engineering field of study
Minimum of one year of related experience in a cGMP facility, including experience with FDA regulations, medical, drug and device products. Installation, Operational and Performance Qualification protocol generation and execution experience Knowledge and understanding of cGMPs, industry guidance, and aseptic techniques
Excellent technical writing and verbal communication skills.
Experienced in negotiating.
Understanding of MES(EBR), historian, oee, and other manufacturing applications.
PC literate with standard office application (Word, Excel, PowerPoint, Project, Access) competency
Good communication skills and leadership skills.
Good judgment and decision skills.
Problem solving and multi-tasking.
Project supervision and project management skills.
Ability to work independently.
Ability to adapt and handle change.
Knowledge of cGMP Process and Product Validation requirements and techniques.

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.

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.

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.

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