Automated Systems Engineer
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This role provides a high degree of autonomy to allow the successful candidate to reach their full potential.
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* Draft, review, and approve documentation related to computerised systems involved in plant expansion and improvement projects.
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* Coordinate and execute commissioning, qualification, and validation activities for computerised systems.
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* Contribute to scheduling, tracking, reporting, and achieving project deadlines.
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* Provide input into operations, qualification, and validation standard operating procedures.
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The successful Automated Systems Engineer will be a key member of the team focused on expansion and transformation of global operations.
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A key aspect of this role is managing qualification of GxP Computerised Systems involved in plant expansion and improvement projects.
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Other responsibilities include:
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* Design, commissioning, and validation documentation – drafting, reviewing, and approving CSV-related elements as appropriate.
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* Coordinating and executing CSV-related commissioning, qualification, and validation activities where applicable.
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* Contributing to the core aspects of operations, qualification, and validation SOPs.
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* Serving as a CSV representative for internal technical group discussions.
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* Understanding and applying industry-specific compliance standards and regulations to all commissioning and qualification activities.
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* Conducting and participating in risk assessments, root cause analysis, and investigations.
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* Reviewing, approving, and signing off protocols, reports, project change controls, and deviations.
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* Proactively highlighting any issues around compliance.
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* Participating in internal and external audits and inspections as required.
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* Working closely with the Client QA department and adhering to their requirements.
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The ideal candidate will have:
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* A degree-level qualification in Science, Engineering, or equivalent.
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* At least 10 years of experience in CSV in Pharmaceuticals or Biopharmaceuticals.
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* Experience in process automation.
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* Understanding and experience in GAMP, GDP, and cGMP environments.
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* Experience with ISA S95 and S88 standards.
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* Experience testing GAMP Category 3, 4, and 5 systems.
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* Knowledge of CFR 21 Part 11.
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* Solid organisational skills including attention to detail and multitasking skills.
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This is an exciting opportunity to work with innovative technologies in a multi-disciplined environment and develop new skills and enhance technical ability.
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In return, the successful candidate can expect:
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* A highly collaborative and respectful work environment.
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* Ongoing career progression and professional development opportunities.
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* An excellent salary and benefits package.
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* The opportunity to work on large-scale capital projects with leading corporate clients.
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