Company: Fresenius Kabi
Posted on: June 17, 2022
Job SummaryResponsible for providing technical support to
operations in terms of equipment/system initial validation and
equipment/system requalification's. Will participate in equipment
improvement teams charged with enhancing the compliance and
performance of plant systems, while considering the regulatory
requirements for change control. The individual must have a
comprehensive understanding of cGMPs and become certified to enter
Controlled Areas of the plant (Grade D, C and up to B/ A). 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.ResponsibilitiesPRINCIPAL
ACTIVITIES PERFORMED BY THE INCUMBENT.
- Schedules and executes equipment commissioning, qualification,
and requalification's 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 to include protocol
preparation, scheduling, protocol execution, and final report
preparation. Participates in presentation of results to Regulatory
Agency when necessary.
- Programs and operates department analytical instruments (such
as temperature/humidity dataloggers) to perform controlled
temperature/humidity chamber qualifications (examples lyophilizers,
warehouses, sterilizers, incubators, etc.).
- Participates in developments/ improvements to validation
programs as needed to remain current with cGMPs and industry
- Participates in teams assembled to specify, install, validate,
troubleshoot and maintain systems and equipment.
- Conducts Validation deviations and/or participates in deviation
investigations to identify root causes and define corrective and/or
preventative actions (CA/PA).
- BS/BA degree in science, engineering, manufacturing technology
or closely related field or equivalent experience in a
- Minimum 1-3 years pharmaceutical manufacturing experience
- Excellent attention to detail and working knowledge of FDA
Regulations/Guidance, and Good Manufacturing Practices
- Strong technical knowledge and experience with pharmaceutical
process, sterilization, and cleaning validation as related to
- Must be proactive, have experience with high performance teams,
strong interpersonal and project management skills
- Must be able to interact with varying levels within the
- Ability to work both independently and in partnership with
others; proven ability to use initiative and drive to achieve
- Strong conflict resolution skills
- Must be willing to travel both domestically and
- Must be able to work multiple shifts as needed to meet
deadlinesAdditional InformationWe 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.
Keywords: Fresenius Kabi, Wilson , VALIDATION ENGINEER, Engineering , Wilson, North Carolina
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