Amgen Sr. Associate Manufacturing - MBR Designer in Dublin, Ireland

Duties

  • Responsible for the development, configuration and testing of Master Batch Records (MBRs) from initial to final design.

  • Responsible for leading MBR development design reviews including liaising with Operations, Process Development and Quality functions

  • Responsible for drafting , executing and reviewing Application Lifecycle Management test scripts and test sets for testing MBR design

  • Responsible for the support and ongoing development of the Amgen Dun Laoghaire MES system in development of MBRs and improving the MES business process.

  • Responsible for training of Electronic Batch Record (EBR) end-users (Supervisors, Operators, Technical/QA/Support staff)

  • Responsible for production support to assist in fast Manufacturing Execution System (MES) issue resolution, including presence in the production suite and also during non-standard shifts

  • Responsible for liaising with production managers, operators and other relevant personnel as part of the review and update of MBRs and during production as required.

  • Responsible for the development, review and update of MES Standard Operating Procedures.

  • Responsible for the preparation and management of MBR change requests and associated change request forms (and other documentation) in a timely manner by liaising with customers, System Owner etc.

  • Accountable for adherence to established timelines and metrics for the change control and CAPA process.

  • Responsible for any applicable equipment integration design, configuration and testing to allow MBR interaction with shop floor equipment - OSI PI, Recipe Managers - Siemens, Rockwell, Kepware OPC Server

  • Responsible for resolving interface errors and stock discrepancies between ERP/MES as required.

  • Liaison with Amgen MES core-team to troubleshoot and develop new ways of working

  • Responsible for providing technical support where required and as directed by Operations leadership

  • Other Responsibilities as deemed necessary by Executive Director Patient Supply or Manufacturing Senior Managers.

Business Execution and Compliance

  • Responsible for owning and tracking Change controls as required and in a timely manner

  • Responsible for liaising with Quality Assurance to ensure that GMP standards are maintained in line with current SOPs, batch documentation and processes

Non-Conformance and CAPA

  • Responsible for owning and tracking Corrective and Preventative Actions (CAPAs) as required

  • Responsible for Class 1 NCs as required

  • Support other investigations, Non-Conformance and CAPA Review Boards where required.

  • Responsible for the implementation of Change Controls related to the Manufacturing facility.

  • Responsible for contributing to and assisting with Corporate, FDA, IMB Auditors and other regulatory bodies during company audits

  • Support any internal & external regulatory agencies activities during inspections.

Staff Training and Qualification

  • Responsible for personal GMP training compliance

  • Support technical training assignments for staff in Patient Supply.

Continuous improvement & Projects

  • Support continuous area improvement, by proactively identifying and supporting implementation of improvement opportunities

  • Support implementation of process changes

Safety

  • Responsible to perform all activities in compliance with Amgen safety standards and site safety procedures.

Business/Administrative

  • Responsible for development of personal annual reviews, goal setting and Individual Development Plans via the Maximizing Amgen Performance (MAP) process.

  • Support the MAP process by completing peer to peer feedback

  • May perform some limited NC Owner duties as required.

Primary knowledge, skills, competencies and relevant experience

Technical Background:

  • Bachelor degree in Science, Engineering, IT or the equivalent combination of experience and education

  • Typically 3-5 years of MES related experience in highly regulated GMP environments

Knowledge:

  • Working knowledge of solid dosage manufacturing and packaging; parenterals in pharmaceutical/biotech industries or aseptic processing

  • Knowledge of regulation requirements (including cGMP, 21CFR Part11)

  • Knowledge of audit handling process

  • Knowledge of Quality Systems (e.g. CCMS, EDMQ, NC/CAPA)

  • Knowledge of validation processes and understanding of validation protocol generation requirements

  • Knowledge of computer systems applicable to responsibilities (e.g. MES, ERP, QMTS, EDMQ)

  • Practical knowledge in continuous improvement tools and methodologies

Skills:

  • MES experience with focus on workflow, S95 & S88 standards & integration from the control layer to ERP via MES

  • Strong attention to details, including the ability to proofread documents and to accurately translate customers’ requirements into meaningful end-user instructions consistently

  • Ability to interpret requirements and apply GMP and regulatory Knowledge as related to documentation

  • Project Management

  • Excellent organisational and communication (verbal and written) skills at all levels of the organisation

  • Strong Technical writing for investigations, procedures and change controls

  • Reliable, pro-active, motivated and enthusiastic individual

  • Ability to help others understand and implement complex instructions

  • Ability to work guided by objectives of the department or assignments

  • Refers to established policies and precedents as needed

  • May set project timeframes and priorities based on project objectives and ongoing assignments

  • Recognizes and escalates problems

Competency:

  • Contributes to department/unit by ensuring quality of tasks/services provided by self

  • Contributes to the completion of milestones associated with specific projects or activities within own department or workgroup

  • Applies knowledge and understanding of internal customer needs

  • Establishes working relationships with others outside area