PACIV, a global leader in industrial automation solutions servicing the Life Sciences sector, is looking for Automation/Validation Engineer(s) for its Puerto Rico office.
PACIV, a global leader in industrial automation solutions servicing the Life Sciences sector, is looking for regular employment-based Automation/Validation Engineer(s) for its Puerto Rico office.
Job Description:
The Automation/Validation Engineer will be responsible for development and execution of the Computerized System Validation (CSV) deliverables for control systems within the BioPharma production facilities. In particular, the resource will participate in the execution of gap assessment and remediation activities for the Data Integrity initiative within the client site.
The resource will also be responsible for development and execution of 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 such as DeltaV, Rockwell PLC/CLx, and SCADA sytems (RSView/RSBatchm iFix, Wonderware within Biopharmecutical manufacturing site processes and systems.
Position Responsibilities/Essential Functions:
Development and execution of gap assessments and remediation activities for the Data Integrity initiatives, within an existing Biotech production facility, for all production industrial control systems.
Strong knowledge of the development and execution of CSV deliverables throughout the System Development Life Cycle (SDLC) such as Validation Planning, User/Functional Requirements, Design Specifications, Testing, Traceability Matrix and Final Reporting for industrial control systems.
Knowledge, familiarity and exposure to industrial control systems (DeltaV, Rockwell PLC/CLx, and SCADA systems (RSView/RSBatchm iFix, Wonderware), including related configuration/programming, S88 Batch programming and field installations.
Understanding and experience with CSV regulations and guidelines such as FDA; cGMP for the 21st Century, 21 CFR Part 11 Guidance: Scope and Application, 21 CFR 211.68, Data Integrity and Compliance with CGMP Guidance for Industry; and ISPE GAMP5.
Requirements:
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Education: Bachelor's degree in Engineering or related science studies.
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Five (5)+ years related work experience including strong knowledge and hands-on experience of computer system validation (CSV) activities in the regulated industries.
Desired Hard Skill Sets:
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Significant understanding and experience with the FDA’s regulations regarding CSV, including data integrity, electronic batch records, and all related industry standards for CSV life cycle.
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Knowledge and experience in the development and execution of CSV deliverables throughout the System Development Life Cycle of industrial automated systems.
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Exposure to control systems validation within regulated FDA environment.
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Familiar with gap assessment methodology, planning and execution activities.
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Understanding of industrial automation programming, including S88 Batch.
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Proficient knowledge of CSV system life cycle concepts and FDA regulatory requirements, including FDA; cGMPs for the 21st Century, 21 CFR Part 11 Guidance: Scope and Application, 21 CFR 211.68, Data Integrity and Compliance With CGMP Guidance for Industry; and ISPEs GAMP5.
Desired Soft Skills:
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Strong analytical and problem-solving skills.
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Deals well with uncertainty and pressure.
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Works well with others, within a team and takes accountability.
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Results driven and self-motivated.
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Strong interpersonal and communication skills (verbal and presentation).
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Organized, with strong computer literacy such as MS Project, Excel, etc.
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Fully fluent in English.
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Job Type: Full-time
