MES Engineer

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Location: Dublin

Type: Contract

Rate: Negotiable

Contact: mtreacy@asset.ie

Reference: MES Eng

Updated: 27/04/2018 17:01:13


Role purpose:

Responsible for the delivery of new and updated Master Batch Records for use in production.

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 Client 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 Client 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 Client safety standards and site safety procedures.

Business/Administrative

• Responsible for development of personal annual reviews, goal setting and Individual Development Plans via the Clients Performance process.
• Support the performance 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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