Software Validation Engineer – Galway

Key Responsibilities:

• Ensures that software validation is carried out in compliance with site/corporate policies and SOPs.
• Ensures that best software validation practices are employed by all departments so that computerized systems which have an impact and criticality on product or process quality are developed, validated and documented in a manner which provides assurance that the system conforms to both established GMP and Technical requirements.
• Collaborates, reviews and approves Master Validation Plans, Validation Protocols, URS, FDS and Software Design Specifications and applicable Risk Assessments along with associated documentation for equipment and systems.
• Ensures that software validation is carried out in compliance with site/corporate policies and SOPs.
• Ensures that best software validation practices are employed by all departments so that computerized systems which have an impact and criticality on product or process quality are developed, validated and documented in a manner which provides assurance that the system conforms to both established GMP and Technical requirements.
• Collaborates, reviews and approves Master Validation Plans, Validation Protocols, URS, FDS and Software Design Specifications and applicable Risk Assessments along with associated documentation for equipment and systems.
• Verifies and audits that validation studies once complete have been adequately recorded, documented and carried out, in accordance with the approved Master Validation Plan(s) and Validation Protocols.
• Ensures that all deviations to protocols and/or deviations to acceptance criteria are adequately controlled, documented and addressed by the Validation Project Team.
• Provides training and collaborationto staff across various functions on software validation to ensure best practice is maintained. Provides training and collaboration with the preparation of validation protocols, software design specifications and associated documentation for equipment,systems and processes.
• Provides software validation/compliance/part 11 training and collaboration in accordance with BSC policies and SOPs.
• Participates in Validation project teams and assists in determining project schedules. Works with teams and other departments across the plant to ensure project adherence.
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• Ensures that software validation is carried out in compliance with site/corporate policies and SOPs.
• Ensures that best software validation practices are employed by all departments so that computerized systems which have an impact and criticality on product or process quality are developed, validated and documented in a manner which provides assurance that the system conforms to both established GMP and Technical requirements.
• Collaborates, reviews and approves Master Validation Plans, Validation Protocols, URS, FDS and Software Design Specifications and applicable Risk Assessments along with associated documentation for equipment and systems.
• Verifies and audits that validation studies once complete have been adequately recorded, documented and carried out, in accordance with the approved Master Validation Plan(s) and Validation Protocols.
• Ensures that all deviations to protocols and/or deviations to acceptance criteria are adequately controlled, documented and addressed by the Validation Project Team.
• Provides training and collaborationto staff across various functions on software validation to ensure best practice is maintained. Provides training and collaboration with the preparation of validation protocols, software design specifications and associated documentation for equipment,systems and processes.
• Provides software validation/compliance/part 11 training and collaboration in accordance with BSC policies and SOPs.
• Participates in Validation project teams and assists in determining project schedules. Works with teams and other departments across the plant to ensure project adherence.
• and applicable Risk Assessments along with associated documentation for equipment and systems.
• Verifies and audits that validation studies once complete have been adequately recorded, documented and carried out, in accordance with the approved Master Validation Plan(s) and Validation Protocols.
• Ensures that all deviations to protocols and/or deviations to acceptance criteria are adequately controlled, documented and addressed by the Validation Project Team.
• Provides training and collaborationto staff across various functions on software validation to ensure best practice is maintained. Provides training and collaboration with the preparation of validation protocols, software design specifications and associated documentation for equipment,systems and processes.

• Level 8 Degree in a relevant discipline
• 4 years plus experience in a similar role
• Excellent communication and interpersonal skills
• Highly organised and excellent attention to detail