Validation Specialist II-III, Temporary
Company: Explore Jobs Search
Location: Pasco
Posted on: January 24, 2023
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Job Description:
To apply please visit:
https://jobs.explorejobsearch.com/job-detail/278506/validation-specialist-ii-iii-temporary
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.SummaryThe Validation Specialist will support the
Engineering, Facility/Labs, and Automation Manufacturing Support
teams (metrology/calibration and maintenance) who are responsible
for scale-up and manufacturing of cGMP protein-based therapeutics
including cell and gene therapies. Responsibilities include but not
limited to cross-functional investigations and closure of quality
events including Deviation, CAPA, and Change Control associated
with facilities, utilities and equipment. Review and approval of
validation documents and strategies. The Validation Specialist also
supports customer project and QA Validation teams and evaluation of
risk assessments in order to maintain continuous improvement at AGC
Biologics.Key Responsibilies
Designs, develops and leads Equipment and Facility Validation
initiatives
Ensures that the Validation Master Plan remains current
Prepares/executes IQ/OQ/PQ protocols for equipment, instrument,
facility and utilities (HVAC, Building Automation System,
Compressed Air, Nitrogen system, and Environmental Monitoring) as
well as related software to ensure compliance and adherence to cGMP
and AGC Biologics validation standards
Identifies and resolves non-conformances/deviations encountered
during IQ/OQ/PQ execution and work with Management to implement
mitigation solution
Helps generate qualification report and helps summarize the results
which will be reviewed by the Management
Performs re-qualification of equipment, facility and utilities as
per change control requirements
Initiates a Problem Report/Record (change control, CAPA etc.) in a
TrackWise system.
Develop and manage documentation for engineering studies ("ES").
Execute ES activities.
Develop and manage documentation for commissioning tests ("CT").
Execute CT activities as required
Develop and maintain the validation traceability matrix ("VTM")
Provide data entry and statistical analysis of data collected
during validation activities
Develop documentation for GMP criticality assessment and coordinate
activities
Interprets validation/user requirements, provides validation
strategy in conjunction with QA and operations organizations,
develops and drafts validation protocols [i.e. Design
Qualification/Installation Qualification/Operational
Qualification/Performance Qualification (DQ/IQ/OQ/PQ),] executes
validations and documents validation results in final reports
Ensures that validations are documented using Good Documentation
Practices and in compliance with Biologics and Regulatory Agencies,
ISO Standards, and AGC Biologics Policies and Procedures
Perform and document investigations related to validation
activities and performs risk assessments of equipment and processes
to support scope of validation
Identify and propose remediation for existing and potential
validation issues; provide technical expertise and provide
solutions to maintain compliance
Provide quality-related discipline expertise to AGC customers and
project teams
Performs other duties as assigned by Management.
Knowledge, Skills & Abilities
Understanding of Biologics Manufacturing, Laboratory testing, and
QA oversight.
Knowledge of ISO and GMP/ICH standards for equipment, facilities,
automation and utilities.
Ability to clearly communicate validation compliance strategy,
principles of quality, and rationale through oral and written
communication techniques.
Demonstrated knowledge of scientific principles and concepts as
they relate to Operations, Facilities, and Engineering teams.
Knowledge of CAPA, change control and deviation programs and
requirements.
Team player who is collaborative with positive attitude.
Demonstrates ability to effectively manage multiple tasks utilizing
organization and prioritization skills, self-motivated.
Strong interpersonal, written/oral communication and problem
solving skills.
Experience with regulatory inspections, internal/external
audits.
Education/Experience
BA or BS with at least 5 years QA-related validation experience or
equivalent work experience or a Master degree in a scientific
discipline with at least 2 years related experience; may include
equivalent work experience in a cGMP manufacturing facility.
Experience with application of validation compliance and principles
of quality which drive QA strategy and oversight.
Experience in facilitating change control,
deviations/investigations, and closure. Knowledge/Experience in
Corrective and Preventative Action (CAPA) facilitation and
closure.
Equivalent education and experience may substitute for stated
requirements.
AGC 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
To apply please visit:
https://jobs.explorejobsearch.com/job-detail/278506/validation-specialist-ii-iii-temporary
Keywords: Explore Jobs Search, Pasco , Validation Specialist II-III, Temporary, Other , Pasco, Washington
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