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Job Description

Validation Engineer

Job Title: Validation Engineer

Location: Bray

About the role:

Be part of the team delivering new products and processes to the TIL-Bray site. You will demand a knowledge of pharmaceutical solid dosage validation procedures with technical understanding of process equipment and unit processes used therein for both drug product and packaged product manufacturing. We ask that you have the delivery of a professional service of the highest possible quality with enthusiasm, and a team ethic. The position is based in the Manufacturing Sciences Department.

Optional hybrid work model.

How you will... contribute:
• Coordination, implementation and compliance oversight of site validation activities including:
• Process validation, hold time and general validation activities in Manufacturing Sciences,
• Clean validation in collaboration with Engineering Services,
• Qualify equipment,
• Computer system qualification,
• Qualify utilities and facilities,
• Requalification activities.
• Assist the Head of Site Manufacturing Sciences and Engineers in the successful on time delivery of the Technical Transfer (New Product Introduction) and Material Qualification schedules.
• Maintain the validation standards within the company.
• Assist and advise on the validation of new/existing processes and equipment and communicate with production/scheduling departments on validation activities.
• Practice and promote Quality Culture mindset and positive behaviours.
• Review and evaluate FAT/FMEA/FS/URS/SDS/HDS/MR documents to guarantee a good design basis is established for all validation studies.
• Report to and update the Quality Compliance Department in Validation Activities across the plant.
• Prepare validation plans; CC/RA/DQ/IQ/OQ/PQ/PV/HT/CQ protocols / reports and associated deviations / NCRs for equipment, facility, utility, process, hold time, cleaning & computerised systems.
• Review validation data.
• Collaborate with vendors, external consultants, internal departments and global Takeda functions on validation topics.
• Conduct Audits on vendors and internal audits within TIL-Bray were deemed necessary by the validation committee or the Quality function.
• Help maintain production, engineering and quality systems and to ensure that the Manufacturing Sciences Department projects are performed promptly and in compliance with the site Quality Management System.
• Review Change Records and Risk Assessments to assess process impact and validation status.
• Participate in change projects relating to Agile improvements, asset upgrades, process improvements and other lifecycle projects.
• Ensure compliance with current industry guidelines relating to validation.
• Participate in training and direct training of Manufacturing Sciences Engineers including the maintenance and improvement of validation SOPs, forms and training manuals.
• Participate in and support regulatory audits.
• Develop/manage Validation/ Manufacturing Sciences Measurements.
• Provide regular progress updates (written and verbal) on projects as reported in project communication plans or by the relevant partners.
• Follow the compliance matrix of business processes and routine departmental tasks.

General Responsibilities
• Participate in any training programs.
• Guide and promote the corporate values of Takeda-ism within the workplace.
• Foster, in cooperation with other TIL-Bray staff, an ethos and culture of safety awareness where safety is accepted as an important part of the business. Ensure that Accident Reports / Near Miss Forms are completed promptly after an event.
• Ensure completion of all SOP, reading, training and assessment.
• Other responsibilities and directed by the relevant Manager or any other Officer appointed by the Board of Directors.

What you bring to Takeda:
• Degree qualified in a Science or Engineering discipline.
• Masters in a related field is preferable.
• Experience with pharmaceutical solid dosage manufacturing processes.
• At least 5 years experience working in a validation role in a regulated environment.
• Excellent knowledge of validation regulations.
• A technical understanding of processes, equipment and computer systems.

What Takeda can offer you:

Full Healthcare Cover - includes dependents

Pension Scheme

Attractive Bonus

Subsidised canteen

Parking facilities with electric car charging points

Health & Wellness programs including onsite flu shots and health screenings

Educational Assistance

#LI-LA1

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 to 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.

Empowering our people to shine:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.

#LI-LA1

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.

Empowering our people to shine:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.

Locations

Bray, Ireland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
Kilruddery Demesne East Kilruddery County Wicklow

Salary Criteria