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SR. COMPUTER SYSTEM VALIDATION ENGINEER
Company:PACIV |
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Job Reference Number |
14565428 |
Client ID: |
RI/004 |
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Posted On: |
Feb 3 2012 |
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Location: |
CORK |
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Job Type: |
Permanent |
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Salary: |
COMPETITIVE SALARY & BENEFITS |
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Benefits: |
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PACIV, a global instrumentation, control systems integration and regulatory compliance engineering firm with offices in Puerto Rico, United States, UK and now Ireland, servicing BioPharmaceutical, Medical Device, F&B and Utilities clients, is looking for permanent role based Senior CSV Engineer in its Ireland office.
Job Description :
The Sr. CSV Engineer will be responsible for leading the strategy, development and execution of the CSV deliverables of an Automation Systems Development Life Cycle (ASDLC) for industrial systems within the BioPharmaceutical and/or Medical Device regulated industry. This consists of Validation Planning, User/Functional Requirements, Design Specifications, Design Qualification (DQ), Testing protocols development and execution (software and hardware) and Final Reporting. It also includes the preparation and/or review of system-wide related procedures such as: Operational, Security, Backup and Restore and Disaster Recovery.
These positions are required to perform within our unique business model (customer intimacy), three interrelated services (instrumentation, control systems, regulatory compliance), as a turnkey solution or independently. These engineers will work under a unique commitment culture, innovative vision, strong values, and trusted brand which guide the decisions and actions of all employees.
If you are interested in taking your technical knowledge and experience to the next level and create, capture and sustain value for yourself, your other colleagues and clients as well as the Ireland community, please send us your CV.
Position Responsibilities/Essential Functions
· Manage CSV projects from concept to execution and maintenance.
· Actively participate among cross-functional teams to ensure projects are delivered on time and to required quality standards.
· Participate proactively as a team member in the implementation of automation projects.
· Develop strategy and planning for CSV deliverables for industrial automation systems as per system development life cycle.
· Lead development and execution team for Computer System Validation (CSV) deliverables such as Planning, User/Functional Requirements, Design Specifications, Design Qualification (DQ), Testing and Final Reporting.
· Prepare and/or review system related procedures such as: Operational, Security, Backup and Restore and Disaster Recovery.
· Comprehensive understanding of all the different control systems including distributed control systems (e.g. Foxboro, DeltaV, Siemens, CLx), programmable logic controllers (e.g. SLC 500, Micrologix, Logix 5000), and HMI/SCADA systems (e.g. iFix, RSView/Batch, Wonderware).
· Profound understanding and experience with regulations for Computer System Validation such as FDA cGMP’s for the 21st Century, 21 CFR Part 11 Guidance: Scope and Application, 21 CFR 211.68, ISPE Risk Based Approach, ICH 9, ASTM E2500, GAMP5.
Requirements
· Education: Bachelor’s Degree in Engineering (preferably Electrical or Chemical) or related science studies.
· Work Experience:
o Minimum ten (10) years related work experience with strong knowledge and hands-on experience of control system commissioning, qualification (C&Q) and validation (CSV) in the regulated industries (BioPharma and/or medical device).
o Knowledge and experience of API, Bulk Chemicals, Fill Finish, Parenterals, Dry Products, Utilities and F&B processes and technologies.
· Desired Hard Skill Sets:
o Strategy, development and execution of computer system validation deliverables for system-development life cycle of industrial automated systems.
o Proficient knowledge of computer system life cycle concepts and FDA regulatory requirements, including FDA cGMP’s for the 21st Century, 21 CFR Part 11 Guidance: Scope and Application, 21 CFR 211.68, ISPE Risk Based Approach, ICH 9, ASTM E2500, GAMP5
o Experience with development of FRS’s, DDS, DQ, Validation and Test Planning, Development and Execution (C&Q/CSV, Installation Commissioning (ICO) and Automation Commissioning (ACO), Loop Checks, Final Reports, SOP’s).
· Desired Soft Skills:
o Strong analytical and problem-solving skills.
o Deals well with uncertainty and pressure.
o Works well with others, within a team, and takes accountability.
o Results driven and self-motivated.
o Strong interpersonal and communication skills (verbal and presentation).
o Organized, with strong computer literacy such as MS Project, Excel.
Other Requirements
· Location: Cork, Ireland.
· Travel: 10% of the time, mostly throughout Ireland to various suppliers, collaborators and client sites.
Compensation
· Competitive Salary and Benefits Package.
Please send your resume to
Via email to:
pacivireland_srcsvengineer@paciv.com
RE: Automation Engineer PACIV-Ireland
Via mail to:
PACIV-Ireland
No. 9 Pearse Street, Kinsale, Co. Cork, Ireland
RE: Automation Engineer
