VALIDATION ENGINEER
Company: Fresenius Kabi
Location: Wilson
Posted on: June 20, 2022
Job Description:
Job SummaryThis role is part of an operational ramp-up team for
new pharmaceutical plant reaching construction and mechanical
completion. Providing operational support for commissioning and
qualification teams and establishing first operational footprints,
developing and revising manufacturing procedures to final operation
platform. The position will require seamless transition into
operation of state-of-the-art high-speed manufacturing/packaging
equipment.
Responsible for providing technical support to operations in terms
of equipment/system initial validation and equipment/system
requalifications. 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.ResponsibilitiesJob DescriptionPRINCIPAL ACTIVITIES
PERFORMED BY THE INCUMBENT
- Schedules and executes equipment requalifications 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
standards.
- 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).REQUIREMENTS
- BS/BA degree in science, engineering, manufacturing technology
or closely related field or equivalent experience in a
manufacturing facility
- 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
sterile products
- 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
company
- Ability to work both independently and in partnership with
others; proven ability to use initiative and drive to achieve
results
- Strong conflict resolution skills
- Must be willing to travel both domestically and
internationally
- 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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