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Job Description
Job title: CSV Engineer
Location: IRL - Bray
Job Purpose:
The CSV Engineer reports to the Engineering Services Manager and will participate in:
* All Computerised System Validation (CSV) activities on site, along with periodic requalification requirements.
* Provide CSV support to capital projects that are executed on site.
The role requires a thorough understanding and experience of the validation requirements associated with a pharmaceutical manufacturing facility.
Responsibilities:
* Support the CSV requirements for site production and laboratory systems.
* Support the management of ongoing CSV re-qualification requirements.
* Work cross functionally to develop and deliver the annual CSV re-qualification requirements.
* Provide CAPEX team with adequate validation support at all times.
* Review vendor documents to support commissioning and qualification requirements.
* Completes the development, review and execution of validation plans, URSs/DQ/FATs/SATs/IQ/OQ protocols/reports.
* Ensures validation non-conformances or deviations are minimised during execution of CSV activities. For issues that do arise ensure they are closed out in a timely manner.
* Supervise vendors/ contractors on site as required.
* Ensuring compliance with current industry regulations and guidelines relating to validation.
* Support department performance against defined KPIs.
* As required, support the Technology Transfer initiatives for incoming new products.
* Encourage actively the culture of teamwork and integration within the Engineering Services Department, and with all other Departments.
* Participate fully in cross-functional training initiatives.
Environmental Health and Safety:
* Participate in site EHS activities and ensure compliance with legislation and best practice.
* Actively foster an ethos and culture of safety awareness, where safety is accepted as an integral part of the overall business.
* Work with all GC personnel, contractors and visitors to ensure that all safety policies, procedures and regulations are fully adhered to across the site on an ongoing basis.
* Ensure compliance with legislative requirements as applicable to commissioning activities and contractor management.
Training
* Preparation and delivery of training material as required.
* Ensure timely completion of all SOP training and assessment tasks.
* Ensure that all training and assessment is accurately and promptly recorded for themselves and other relevant personnel in accordance with TILGC procedures.
* Maintain and improve their professional knowledge base. Keep up to date with all current trends and relevant legislation.
GENERAL RESPONSIBILITIES:
* Participate fully in any cross functional training initiatives.
* Drive and promote the corporate values of Takeda-ism within the workplace.
* Actively foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business.
* Ensure timely completion of all SOP, reading, training and assessment.
* Other duties as required and directed by the relevant Manager or other Officer appointed by the Board of Directors.
EDUCATIONAL REQUIREMENTS:
* 3rd level Engineering or Science Degree, or equivalent
RELEVANT EXPERIENCE:
* At least three years validation experience (CSV) within a pharmaceutical setting.
* Knowledge of validation practices and regulatory guidelines for a pharmaceutical facility.
* Experience with regulatory audits, in particular representing computer system type issues.
* Experience of writing validation plans, requirements gathering, design documentation, system configuration, system testing and troubleshooting.
* Experience working with Kneat Paperless Validation would be an advantage.
* Knowledge of 21CFR Part 11 requirements, ER/ES and data integrity guidelines would be an advantage.
* Knowledge of working in any of; Active Pharmaceutical Ingredient manufacturing, Drug Product or Secondary Packaging would be an advantage.
SKILLS/COMPETENCIES:
* The ability to work in a highly regulated industry and strive for continuous improvement.
* Excellent interpersonal and communication skills.
* Strong Quality orientation.
* Well organised and adaptable to change.
* Excellent technical writing capability.
* Ability to work well with others across other departments.
* Working knowledge of quality systems.
* Ability to work on own initiative.
* Willingness to contribute beyond role specific duties and participate in site improvement initiatives.
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