Pfizer Operation Support Specialist in Grange Castle, Ireland
Job Title: Operations Support Specialist
Department: Drug Substance - Small Scale Facility (SSF)
Position Reports to: Operations Support Lead
Pfizer Ireland Pharmaceuticals Grange Castle manufacturing plant is situated on a 90-acre site in South Dublin. The focus on the site is Biopharmaceuticals and Vaccines. This is an opportunity to join a world class facility who is dedicated to bringing therapies that will significantly improve patients' lives. We are licensed for the manufacture of commercial and clinical trial materials, but we also have a very significant research and development function.
The Operations Support Specialist will play a key role in supporting the Operations Support team.
Operations Support Team of Specialists in Grange Castle are system and operational process subject matter experts ( SME 's). The Operations Support Specialist balances the requirements of day to day support, implementation of system/operational process continuous improvements ( CI ) and corrective actions, preventive actions ( CAPA 's).
The ideal candidate will be self-driven and will be recognized as having a high level of knowledge/skill. Project management, tracking, monitoring, and implementing initiatives to improve efficiency will be a key requirement.
This role will support the current Manufacturing Operations in Drug Substance- Small Scale Facility (SSF) in Grange Castle and requires a technical competence level to handle manufacturing issues, and the ideal candidate should have experience in executing projects in line with lean / six sigma tool and techniques.
Working to implement a culture of Zero Defects through partnerships with Manufacturing Operations
Providing subject matter expertise and support for business systems and processes, technologies and products for manufacturing process
Providing leadership in the use of OE and Lean principles to optimise our technical and business processes
Managing/supporting core meetings - Investigations Meeting, Metrics Meeting, Technical & Regulatory forum, Materials Review Board (MRB) meeting, Change control, Safety and Compliance, Hoshin (Project Management)
Reporting/managing of compliance and metrics
Assisting with closure of Quality system investigations and implement process CAPA's and performance improvements
Coordinating local document periodic review process, and supply of controlled documents for manufacturing, e.g logbooks and Batch records
Managing supplier complaints process and MRB
Supporting audit preparation and Inspection readiness
Authoring and Approval of SOP's, Forms, Protocols Batch Records, Training content & other documents for operations through collaboration with the various departmental SME's
Carry out organisational activities such as purchasing and co-coordination of communication information.
Managing projects impacting Manufacturing Operations arising from Capacity Enhancement, Continuous Improvement/Lean Management system, Technical Process Improvements.
Demonstrating company values and Pfizer competencies
Working knowledge of Upstream/Downstream manufacturing operations is preferred, though not essential.
Excellent leadership, influencing, communication, and interpersonal skills.
An ability to work independently and as a member of a team in a complex, fast-paced and goal driven environment.
Strong troubleshooting and decision-making capability.
Demonstrated ability to lead change.
Working knowledge of Six Sigma and Lean Tools is preferred, though not essential.
Ability to build a culture of positive engagement.
- Third level Qualification in Science, Engineering or equivalent is preferred, though not essential. Exceptions may be considered where relevant skills/experience and correct attitude and behaviors exist (this may be supplemented by further education in parallel).
People and Values
Develop CI capability and utilize CI tools to drive improvements within your area
Proactive engagement with key stakeholders.
Best practices developed and shared with other teams /sites.
Best practices actively sought and copied.
Proactive & effective communication within and across shifts.
This job description indicates the general nature and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of all activities, duties or responsibilities required of the incumbent. Incumbents may be asked to perform other duties as required.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.