CSV Engineer

at  Takeda Pharmaceutical

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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.

MORE ABOUT US:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

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.

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.