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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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