Operations Engineer (Manufacturing)

AbbVie

Dublin, Ireland

Job Description

The Operations Engineer role is dynamic and central to our team's success, offering a wide range of responsibilities. You'll play a key role in maintaining and improving compliance across the manufacturing area. Collaborating with your team and production supervisors, you will identify and implement focused improvement initiatives to ensure the highest standards of compliance, safety, regulatory, operational, and organisational excellence.

This role has responsibility for managing the review of all executed manufacturing documentation to facilitate timely shipment of product, as well as ensuring batch manufacturing records (BMRs) and manufacturing procedures are maintained to the highest standards. Manufacturing investigations are managed within the scope of the role, as well as facilitating inter-departmental communication and promoting a culture of continuous improvement.

You'll track important metrics and ensure alignment of the manufacturing department with strategic initiatives.

The role blends technical expertise with leadership, teamwork and problem-solving skills to achieve optimal outcomes in the OSD production facility.

Roles and Responsibilities

Work at the core of our site as part of the Process Operations Team delivering pharmaceutical OSD products in line with customer and patient demands;
Manage the manufacturing compliance team who are responsible for preparing/maintaining operating procedures, work instructions, and process documentation in addition to review of executed manufacturing records;
Support real-time quality impact assessments, escalations, and resolutions of operational challenges;
Work cross-functionally, primarily with the Technical Operations, Engineering and Quality Assurance Teams, to investigate and troubleshoot potential challenges and resolve complex investigations through implementing innovative and robust solutions;
Support the delivery of right first time (RFT) manufacturing, including tracking key performance indicators and improving RFT execution on the manufacturing floor;
Lead and support the manufacturing audit readiness program;
Support on time completion of quality management system actions relating to manufacturing activity;
Identify and implement continuous improvement projects across the AND site, acting as the manufacturing voice in key cross-functional meetings to improve product quality, compliance and future proofing the manufacturing floor;
Support day-to-day manufacturing floor operations, such as co-ordination of non-routine manufacturing activities, material management and recipes for commercial products, chairing of the daily Tier 1 meeting

Qualifications

Degree qualification or equivalent in relevant science or engineering discipline and suitable experience with at least 3 years experience;
Strong track record of troubleshooting and resolving technical problems;
Strong understanding of GDP and GMP principles;
High level of attention to detail, Must be results driven striving to meet all targets and metric standards as set by site/department and division leaders;
High level of communication and time management skills to effectively promote the execution of all manufacturing projects in line with quality, safety, environmental and operational requirements.

Ownership/Accountability:

The position has a high level of autonomy and individuals are expected to work on their own initiative;
Shows a high level of tenacity to ensure closure of issues;
This position is crucial in maintaining the compliance of validated systems ensuring that any changes or modifications are documented and actioned;
Always Demonstrates an ethos of Right First Time behaviors;
Adheres to and follows all procedures policies and guidelines ensuring compliance with cGMP and HPRA/FDA regulations and company policies, procedures and guidelines;
Demonstrates leadership in continuous improvement initiatives to streamline operations within the relevant safety, environmental and cGMP requirements;
Demonstrates leadership in maintaining and improving all aspects of compliance with relevant cGMPs;
Provide technical leadership to functional areas and collaborates with key stakeholders;
Provides leadership in projects related to API manufacturing;
Provide leadership to API shifts or project teams as required.