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

Fresenius Kabi Melrose Park, United States

1 week ago

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.

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 40,000 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:
Recruitment Fraud Alert

Fresenius Kabi is aware that scammers may attempt to impersonate our recruiters.

While we have limited ability to stop these illegitimate efforts, there are some things you can do to protect yourself and not waste time communicating with an imposter.

Check the email address – messages from our recruiters will always come from a company account with the Fresenius- domain.

We have seen imposters send emails using

"Fresenius-"

which of course includes an extra "a" in "Kabi."
Check our website to see if the position you were contacted about is actually posted.
Be wary if someone asks you for personal information.

We do not need your driver's license, social security number, or bank account information before we have made you a conditional offer of employment.

Refuse to pay any upfront fees. Fresenius Kabi never charges you a fee to apply for a job at Fresenius Kabi.

We will not send you an invoice for equipment (such as a laptop) that we promise to order and reimburse you for once you start working.

If you have any questions at any stage of the process, contact us at

. Do not use any contact information in an unsolicited email. We look forward to talking to you about joining our team.

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