Validation Engineer (Contract)
Company: AGC Biologics
Location: Seattle
Posted on: February 23, 2021
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Job Description:
AGC Biologics is a leading global Contract Development and
Manufacturing Organization, with a deep commitment to improving
life quality by bringing new biopharmaceuticals to market. Because
of our dedication to building and empowering our internal teams,
AGC Biologics is an innovative leader in the industry with an
extensive network of cGMP facilities in the US, Europe and Asia. As
such, we deliver a deep expertise, dynamic solutions and
technologies, as well as customized services for the scale-up and
cGMP manufacturing of protein-based therapeutics. We forge
exceptionally strong partnerships with our clients, and we never
lose sight of our pledge to deliver a reliable and compliant drug
substance supply. Right. On time. For more information, visit
www.agcbio.com .SummaryAGC Biologics is seeking an energetic and
enthusiastic individual with a strong background in Validation or
Engineering in biotechnology and/ or pharmaceutical manufacturing
to join the Validation Team within the Quality Group. This position
will primarily contribute to the qualification/validation of
facilities, utilities, laboratory equipment, and computer systems
and the maintenance of a validated state for existing equipment.
Additionally, this position will lead complex validation projects
and teams.Principal Responsibilities* Generate, review and execute
qualification/validation documents for the qualification/validation
of facilities, utilities, laboratory equipment, cleaning, and
computer systems.* Evaluate specifications to determine test
scripts and acceptance criteria to demonstrate that the equipment
is fit for its intended use.* Perform validation impact
assessments* Investigate, resolve and close deviations and
associated CAPAs.* Generate and maintain validation templates,
procedures, master plans and reports* Apply risk analysis methods
to validation* Lead complex validation projects and teams* Train
and coach Validation Engineers in validation principles* Generate
and review Change Controls and SOPsKnowledge, Skills & Abilities*
Excellent technical writing skills. In-depth knowledge of
pharmaceutical processing. Qualification of facilities, utilities,
manufacturing equipment and analytical equipment including
automated equipment, validation of sterilization processes and
IT-based computerized systems.* Proven expertise in
planning/organization/execution of validation activities, following
up on results and resolving complex problems with cross functional
teams.* Ability to work hours necessary to support production and
/or maintenance activities.Education/Experience* BS degree in Life
Sciences, Engineering, or related discipline required.* 2 plus
years' experience in a regulated pharmaceutical/medical technology
environment required* Previous direct experience with regulatory
inspections highly desirableAGC Biologics offers a highly
competitive compensation package and a friendly, collaborative
culture that values personal initiative and professional
achievement. AGC Biologics is an equal opportunity employer. All
qualified applicants will receive consideration for employment
without regard to age, ancestry, color, family or medical care
leave, gender identity or expression, genetic information, marital
status, medical condition, national origin, physical or mental
disability, political affiliation, protected veteran status, race,
religion, sexual orientation, or any other characteristic protected
by applicable laws, regulations and ordinances
Keywords: AGC Biologics, Seattle , Validation Engineer (Contract), Engineering , Seattle, Washington
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