Manufacturing Specialist (MES)

Manufacturing Specialist (MES)

The Manufacturing Specialist (MES) - will report to the Senior Manufacturing Manager of Purification and will be responsible for development, configuration and testing of Master Batch Records (MBRs) from initial to final design.

The successful candidate will have at least five years' experience in a pharmaceutical or biotech industry and will have demonstrated competency in leading teams to deliver complex MBR designs in time with project and commercial timelines.

The ideal candidate will have:

• Broad technical experience in MES systems, Wernum experience preferred
• Experience of working in pharmaceutical manufacturing operations or have a demonstrated capacity to learn quickly and adapt to new technology.
• The ability to adapt quickly to the demands of purification and aseptic filling manufacturing

What your responsibilities will be:

MES Technical Expertise

• 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 Validation and Quality functions and external functions such as IT, R&D as required.
• 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 Grifols World Wide Operations 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 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 , Quality, etc.
• Accountable for adherence to established timelines and metrics for the deviation, 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 PCS7, Wonderware. Wernum, etc.
• Responsible for resolving interface errors and stock discrepancies between ERP/MES as required.
• Liaison with Grifols 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 Manufacturing Senior Management Team

Accountable for Delivering Results by:

• Ensuring that all metrics relating to schedule, output, quality, safety and reporting are met.
• Communicating issues and promptly escalating issues that may jeopardise manufacturing deliverables.
• Accountable for work which is guided by operational and project objectives and with minimal supervision
• Manage multiple assignments and processes
• Independently determine approach to projects
• Independently develop solutions that are thorough, practical and consistent with functional objectives
• Partners and communicates effectively with other internal and external departments and support functions to ensure positive working relationships.
• Extends capabilities by working closely with senior staff / experts within and outside organisation

Compliance/Quality

• Contribute to and assist with Corporate, HPRA & FDA auditors and other regulatory bodies during company audits.
• Accountable for the safe operation of the area ensuring all safety policies are adhered to and that any incidents are reported in a timely manner. Promotes a positive safety culture
• Knowledge and Problem Solving
• Broad knowledge within own speciality area - Accountable for enhancing own knowledge through understanding business trends and objectives
• Knowledge of industry and business principles
• Understands the core business process and purpose of the functional areas within Grifols commercial process
• Handles diverse scope of issues that require evaluation of a variety of factors including current business trends.
• Implement, assign, lead or participate in projects and develops own project management techniques

Who you are

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Bachelor's degree in Engineering or Science or related industry qualification
• Working knowledge of operations in pharmaceutical/biotech industries or aseptic processing an advantage
• Knowledge of regulation requirements (GMP & IT/System Integration, etc)
• Typically, 5 plus years' experience in an operation's pharmaceutical environment.

Grifols understands you want a challenging and rewarding career in a critical function such as Corporate Communications. We'll help you grow professionally.

Information about Grifols is available at www.grifols.com

Grifols is an equal opportunity employer.

• Onsite position
• Flexible schedule: Monday-Thursday 7:45 to 17:15 and Friday 8:00-15:00