CSV Specialist
Company: CSL Behring
Location: Kankakee
Posted on: August 4, 2022
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Job Description:
With operations in 35+ nations and - 27,000 employees worldwide,
CSL is driven to develop and deliver a broad range of lifesaving
therapies to treat disorders such as hemophilia and primary immune
deficiencies, and vaccines to prevent influenza. Our therapies are
also used in cardiac surgery, organ transplantation and burn
treatment.CSL is the parent company of CSL Behring and Seqirus. CSL
Behring is a global leader in the protein biotherapeutics industry,
focused on bringing to market biotherapies used to treat serious
and often rare conditions. CSL Behring operates CSL Plasma , one of
the world's largest collectors of human plasma, which is used to
create CSL's therapies. Seqirus is the second largest influenza
vaccine company in the world and is a transcontinental partner in
pandemic preparedness and a major contributor to the prevention and
control of influenza globally.We invite you to take a look at the
many career possibilities available around the globe and consider
building your promising future at CSL by becoming a member of our
team!The Computer System Validation Specialist will be responsible
for developing and executing the Computerized System Validation
(CSV) deliverables for control systems within Execution Systems
(ES) and interfaces. Responsible for the implementation of
Execution Systems projects and programs at their respective site.
Maintain the validated status of ES platforms for manufacturing
site.Responsibilities: Design, modify, develop, write, review, and
implement all Computer System Validation (CSV) documents,
protocols, and reports for validation and qualification
work.Support maintenance and evolution of Standard Operating
Procedures (SOP) for computerized and manufacturing systems.
Generate changes reports or documents for new or modified
equipment.Validates and coordinates all CSV activities by constant
communication with affected departments; oversees and reviews
validation area processes and procedures; Review and approve
computer system change controls, discrepancies, CAPAsMaintain
change management procedures and processes in collaboration with
Quality.This position is responsible for ensuring cGMP/Regulatory
compliance with internal/external policies and, guidelines,
including internal SOP's, departmental standards and
conventions.Develop and execute CSV deliverables, as per the System
Development Life Cycle (SDLC), such as Validation Planning, URS,
SDS, Testing, Traceability Matrix, and Final Reporting for
industrial control systems including SIMATIC PCS 7, distributed
control system, PLCs, and SCADA.The resource will also participate
in the execution of gap assessment and remediation activities for
the Data Integrity initiatives within CSL manufacturing
sites.Provide support to internal and external audits and
experience with audits readiness and pressure test. Support sites
during health authority inspection as required, e.g., describing
the validation approaches across multiple locations, expert input
into questions related to CSV.Participate in assessing system
reviews, deviations, CAPA, Changes, continuous improvement, and
troubleshooting related to Global ES Systems and
Applications.Monitor compliance adherence of ES platforms both
globally and locally with the sites.Coordinate CSV/SDLC training
and education to ES teams.Position Qualifications and Experience:
Experience: 5+ years experience with CSV methodologies in operation
IT, OT, and Automation position with a good understanding of
pharma, biotechnology, chemistry, and food industries.Demonstrated
knowledge and experience with CSV regulations and SDLC guidelines
for life-sciences and related best practices for compliance and
risk based approach.Experience with Automation and MES projects and
computer validation methodologies.Experience in writing, reviewing
and executing CSV documentations (IQ, OQ, PQ) and CSV inspection
readiness preparations and/or directly support regulatory agency
inspections.Exposure to Execution Systems technologies, including
automated data collection, historian applications (OSI PI), SCADA,
automated decision control, workflow, database applications, and
interfaces to ERP, LIMS, etc.Knowledge of industry standards
related to computerized systems and Electronic Records/Electronic
Signatures; 21 CFR Part 11, Part 820, Annex 11,
GAMP5.Capabilities:Working knowledge of software development
lifecycle (SDLC) model and validation practices of various
computerized systemsUnderstanding of business and manufacturing
logistics and processes.Proven ability to work within and
contribute to a high performing team.Self-motivated, demonstrates
initiative, propensity to drive changeDetail oriented, with strong
written and verbal communication skills.Strong understanding of US,
European, and or Australian applicable regulationsEducation:
Bachelor's in Engineering, Computer Sciences or similar fieldWorker
Type:EmployeeWorker Sub
Type:RegularPDN-94ae9086-70c9-4217-9b93-55e898ca1a01
Keywords: CSL Behring, Joliet , CSV Specialist, Other , Kankakee, Illinois
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