Validation Engineer III
Company: AGC Biologics
Location: Longmont
Posted on: June 23, 2022
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 and cell and gene
therapies. 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
Engineer III 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 Engineer III 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 cross function team to
implement mitigation solution
- Generates and reviews qualification report and helps summarize
the results which may be viewed by clients and regulatory
agencies.
- Performs re-qualification of equipment, facility and utilities
as per change control requirements
- Assesses/Initiates/Owns a Problem Report/Record (change
control, CAPA etc.) in a TrackWise system
- Develop and manage execution and documentation for engineering
studies
- Develop, execute and document for commissioning tests.
- Develop and maintain the validation traceability matrices
- Anaylze and evaluate data collected during validation
activities
- Develop documentation for GMP criticality assessment and
coordinate activities
- Interprets validation/user requirements, develops 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
- Collaboratively 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 5-7 years QA-related validation
experience or equivalent work experience or a Master degree in a
scientific discipline with at least 4 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.Compensation Range$87,417-$104,900AGC 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 anyother
characteristic protected by applicable laws, regulations and
ordinances
Keywords: AGC Biologics, Longmont , Validation Engineer III, Engineering , Longmont, Colorado
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