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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 re-qualification 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.
  • Participate in the control of Safety and Environmental programmes.  Adhere to safe working practices as set out in the Safety Statement and other company safety rules.
  • 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

  • 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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Grange Castle, Ireland

Employee

Regular

Full time


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