Operations Support Specialist

Job Title

Operations Support Specialist

Requisition

JR000015439 Operations Support Specialist (Open)

Location

Dublin, IRL

Additional Locations

Job Description Summary

Operations Supports Specialist

Manufacturing Operations

Job Description Summary
• This role will be part of our Manufacturing Operations Team in our College Park Manufacturing Facility.
• The successful candidate will support the development of the site by participating in cross functional teams to deliver all project milestone, supply, and batch manufacturing activities with a safety first, quality always mindset.
• The Manufacturing Operations Support Specialist role involves driving commercial operations, continuous improvements and standard work principles at the single use multi-product biotech facility by ensuring adherence to divisional policies and guidelines as well as regulatory requirements.
• The role requires a strong work ethic, be self-motivated and require little supervision, and have a desire to continue learning and improving.

• The role must have a strong sense of responsibility, a high emphasis on Quality, Integrity, Discipline and Teamwork.

• As an integral part of the Operations Team, the role supports all Operations’ responsibilities, including taking ownership of specific tasks and interactions with support functions.
• This is a days-based role focused on supporting the Operations Shift team by managing quality deviations, Continuous Improvement, Document Updates and batch record reviews.

Job Description

Responsibilities:

• Maintain a safe, cGxP compliant work environment at all times.

• Participate in project teams and improvement initiatives.

• Drive a culture of Engagement and Continuous Improvement through identifying and implementing opportunities for improvement in process efficiency and compliance.

• Responsible for the generation and approval of GMP documentation to support compliance and regulatory expectations for manufacturing operations: change control management and implementation, closure of technical investigations, process improvement opportunity identification through implementation, regulatory license section authoring through response-to questions, health authority inspection SME support, and more.

• Work with the Operations Team to ensure the effective and efficient on-time delivery of batch production.

• Support operations team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g. EHS metrics, Schedule Adherence, compliance and team training.

• Provide assistance and/or support to maintenance, engineering, quality or other colleagues as required.

• Requires an understanding of Operations processed within CPMF, proposing technical and efficiency changes where required to meet the demands of the business or in response to any requirements for process changes that may occur.

• Pull together cross functional teams to deliver on deviations, improvements and equipment changes that will move the production processes forward in the facility.

• Support implementation of future updates to the batch recipe on the PCS (process control system), the BOM (bill of materials) and the EBR (electronic batch record) for specific process steps.

• Maintain a high level of personal expertise and working knowledge of all aspects of the manufacturing process and process equipment through continuous training and development.

• Resolve issues and identify risks and escalate in a timely fashion.

• Adhere to Right First-Time principles.

• Ownership of Operations deviations ensuring thorough technical reviews and proposal of effective CAPAs to reduce repeat occurrences.

• Support review and closure of CBRs / PBRs within Operations team.

• Coach Operations team on GDP / RFT execution. Identify and implement document updates to improve Operations RFT metrics.

• Manage Operations Right First Time metrics from batch documentation and identify learnings and improvements for Operations team.

Education / Experience / Skills:

• Previous experience of production operations with a strong focus on attention to detail and compliance to all regulatory standards.

• An ability to work independently and as part of a team. The individual in this position will be able to organize their own work on a routine basis and requires minimal supervision.

• Minimum certificate level qualification in a related discipline (Chemistry, Engineering, Biotechnology etc.) plus 2-3 years relevant experience in a cGMP commercial manufacturing environment.

• Experience in working in cross functional teams.

• 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.

• Good interpersonal and communication skills, verbal and written.

• Collaborator with strong levels of engagement with individuals and teams.

• High level of delivery and work completion.  A proven track record of delivering on commitments.

• A knowledge of Continuous improvement principles and tools such as fishbone analysis, 5 Why’s methodology etc.

• Experience of computer systems such as Master Control, SAP and Automation Systems.

Working Conditions: 

This will be a day-based role with a flexibility allowance as part of the renumeration package to cover ad-hoc out of office batch scheduling requirements. Due to the nature of this frontline position, on site work is a requirement. 

Disclaimer: 

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification.  They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. 

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