Senior Validation Engineer

Job Summary

In this role, you will be reporting to the Engineering Manager the Sr Spec, Validation Engineer will provide continuity for the validation program for West Waterford by writing, reviewing and approving validation documentation.

Essential Duties and Responsibilities

• Responsible for assuring compliance to West Pharmaceutical Systems.
• Ensure that the validation requirements are documented to provide direction for meeting the validation needs of the customers, regulatory bodies, manufacturing plants, research & development, IT and laboratory groups.
• Provide guidance to system/process stakeholders for validation documents, as to content and format of validation life cycle documentation.
• Write protocols and reports assessment criteria (Validation Rationale), compliance, guidelines, specifications, etc.).
• Review and approve validation life cycle documentation, including change control documents, specifications, protocols, deviations, and reports.
• Provide guidance during protocol incident process, including reporting, investigations and approval of resolutions.
• Keep current with the industry standard practices and FDA requirements for validation.
• Write/revise validation templates and validation plans.
• Management of 3rd party service contracts for facility utility related systems.
• Responsible for scheduling or performing periodic reviews or re-qualification to maintain validated status of equipment, facilities and utilities as defined by West master plans and SOI’s.
• Work with vendor representatives on direct and indirect facility/utility systems for start-up and on-going testing, witnessing and trouble shooting.
• Support CAPA, change control, deviations, risk analysis, root cause analysis and other quality system deliverables for the engineering group.
• Supports and complies with engineering standards, drawing controls and West SOI’s for the successful operation of facility/utility systems.
• Generation and periodic review of engineering related SOI’s for the engineering group.
• Supports on-going and new projects associated with direct and indirect systems through planning, executions and witnessing of commissioning and validation protocols.
• Compile data on facility related systems for presentation at managements/quality review forums.
• Support standardisation and harmonization of existing & new facilities and implement standards at through collaboration with Global Facilities group.
• Apply global technical engineering guidelines to support and standardise facility engineering.

Basic Qualifications:

• Minimum Bachelor of Science Degree in Engineering or Science.

Preferred Knowledge, Skills and Abilities:

• Minimum 5 years of experience writing, approving and executing validation protocols and reports, specifically in the following areas: Process Validation, Steam Sterilization, Equipment/Utility Qualification and Computer System Validation 
• Ability to comprehend computer systems applications and business/manufacturing processes
• Strong competence in IT
• Good verbal and written communication skills 
• Excellent interpersonal skills with the ability to work with all levels within the organisation.
• Team player.
• Structured way of working & strong organisational skills
• Ability to interact with suppliers, customers and external contractors.
• Knowledge of current ICH, ASTM, FDA, ISPE and ISO standards and guidelines and application of same for all new projects.

Travel Requirements