Sr. Associate Manufacturing – MBR Designer

Category: Manufacturing
Job ID: R-70173
Employment Type: Full time
Location: Ireland – Dublin
Posted Date: February 5, 2019

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

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