Astellas Pharma Inc.

Engineering Administrator

Building your career at Astellas continues to offer inspiring challenges and a chance to make your mark in doing good for others.

Our open and progressive culture is what makes us Astellas. It is a culture of doing good for others and contributing to a sustainable society.

Based in our Kerry Plant and reporting to Lead Pharma Manu Engineering Tech KP, this role will be responsible for managing our Validation Document Storage, coordinating document workflows, assisting departments with periodic reviews, and performing various administrative functions. We are seeking a highly organised and detail-oriented Engineering Administrator for Document and Validation Control to join our team.

Join us in this dynamic role and contribute to our team's success at Astellas. Apply now to be part of this exciting journey.

About This Job

Validation Document Storage and Filing

• Organise and categorise documents into Process, Equipment, Lab, IT/General, and Quality categories.
• Log and index every incoming document, ensuring all entries are complete and accurate.
• Update document log approvals and revisions, maintaining version control and document indexing.
• File associated documents (e.g., PCRs with OQs) and handle SID forms based on CS number requirements.

Collaboration with Site Teams and Crown Users

• Coordinate with Crown users on-site for deliveries, returns, and document storage.
• Maintain communication for new box deliveries or updates to ensure seamless operations.
• Support departments with periodic document reviews by providing document revision status and approval dates.

Purchase Orders and Invoice Management

• Generate purchase orders and process invoices through SAP, ensuring accuracy and adherence to procedures.
• Communicate with requesters and verify approval before invoice processing.
• Maintain records of Capex budgets and fixed asset requests.

Document Control and Vault Management

• Review and manage validation documents on Veeva Vault, approving or rejecting as needed.
• Monitor and update CSV inventory in Vault, tracking any decommissioned items.
• Support the ValGenesis - VLMS system for routing and approving validation documents, completing access requests, managing user profiles, and running reports.

Supportive Administration and Group Coordination

• Handle access requests, hardware requests, and general administrative duties for the PTG team.
• Manage the PTG distribution list, stationary press, and group stationary budget.
• Arrange vendor accommodations and transportation, organising all necessary logistics.

Essential Knowledge & Experience

• Strong experience with document management, validation filing, and tracking systems (e.g., SAP, Veeva Vault, Trackwise EQMS).
• Exceptional attention to detail and organisational skills.
• Proficiency in Microsoft Office Suite, with advanced Excel skills.
• Excellent communication and collaboration skills.
• Ability to manage multiple tasks and deadlines effectively.

Preferred Qualifications:

• Previous experience in a quality or compliance role within a regulated industry (e.g., pharmaceuticals, medical devices).
• Knowledge of validation document processes (IQ, OQ, PQ).
• Familiarity with ValGenesis VLMS and Trackwise EQMS.