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SR Manager Equipment Validation

  • Permanent
  • Anywhere

Website Fresenius Kabi

Fresenius Kabi

Company : Fresenius Kabi

Country: United States

Location : Wilson, North Carolina

Post: Fri, 03 Feb 2023 20:59:45 GMT

Expires: Fri, 03 Mar 2023 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————

POSITION SUMMARY
This role is responsible for supporting the facility with technical expertise, problem solving abilities, and facility qualification. The Equipment Validation department will implement new equipment qualification, provide technical support for the Operations Department and maintain site Validation master plan and revalidation requirements. Also responsible for formulating, reviewing, and approving qualification protocols related to manufacturing operations. These responsibilities include; equipment, computer systems, facilities, and utilities.

Job Description

*PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT*

* Identify, obtain or create a development report as related to qualification that outlines the approach and Validation justification/ rationale, and include existing reports from the site.
* Plan and lead qualification program in collaboration with Site Quality, Operations, and Technology.
* Provide technical expertise to the Validation Department for the creation of equipment protocols.
* Work in conjunction with Technology Transfer, Engineering and Maintenance Departments to provide technical support to manufacturing, to ensure that manufacturing equipment is qualified and maintained in a current state of requalification, and resolution of problems/issues concerning compliance and equipment.
* Manage the execution of Validation programs to demonstrate the qualification of the manufacturing facility, utilities and equipment as applicable.
* Work with the organization for the resolution of problems concerning qualification issues and product disposition.
* Prepare and defend qualification strategy to regulatory agencies.
* Assist in the development of qualification protocols and reports.
* Provide resources and technical expertise in meeting compliance commitments and in the resolution of investigations to determine product disposition as applicable.
* Ensure that system preparation and qualification meet cGMP’s and company compliance standards as well as and industry expectations.
* Assist project teams in the assessment of business factors including: quality, cost, capacity, facility/equipment capabilities, schedule and regulatory requirements.

*REQUIREMENTS*

* B.S. degree in Engineering or related field with a minimum of ten years directly applicable experience.
* Must have experience in computers, high mathematics (i.e., calculus and/or statistics), and technical writing.
* Must have excellent computer software usage skills including, but not limited to MS Word, MS Excel, MS Project and MS Access.
* Must have excellent knowledge of mechanical equipment engineering and functional testing.

Job Type: Full-time

Benefits:
* 401(k)
* 401(k) matching
* Dental insurance
* Employee assistance program
* Employee discount
* Flexible schedule
* Flexible spending account
* Health insurance
* Health savings account
* Life insurance
* Paid time off
* Parental leave
* Professional development assistance
* Referral program
* Relocation assistance
* Tuition reimbursement
* Vision insurance
Schedule:
* 8 hour shift
* Day shift
Supplemental pay types:
* Bonus pay
* Signing bonus

Work Location: One location

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