Address
Form of work
SalaryProduction Operator - Level 1 (BTA)
Start Date ASAP
Location Ireland - Dunboyne
Duration 11 months
Contract Type Fixed Term
Remote Role Y/N No
Role Description:
This role is part of the Manufacturing Self-Directed Work Team/Hub at our new client site, a multi-product biotech facility in Dunboyne, County Meath, Ireland. The organizational structure at the site will be based on self-directed work teams (SDWT) where decisions will be made at the level where the data exists.
The Production Operator is responsible for all procedures and processes associated with manufacturing Drug Substance at our client site in Dunboyne. They must ensure that all work is carried out at the highest standards of safety, quality, and compliance. The Production Operative will be responsible for carrying out manufacturing operations involved in the production of biologic drug substance on their designated shift.
Key responsibilities include executing an automated recipe using paperless technology to progress the drug substance through inoculation and cell culturing activities, leading to filtration and purification of the product in a state-of-the-art single-use technology-based facility. The incumbent will be involved in setting up the single-use equipment between runs and carrying out the production process according to world-class GMP and EHS principles. The Production Operator will also drive optimization and improvement of the processing activities through the use of standard work and lean processing techniques, while supporting the operations team to consistently deliver on specific Key Performance Indicators (KPIs).
At all times, this role is focused on delivery to the patient through adherence to the Dunboyne culture, which includes a commitment to safety, focusing on getting it right the first time in everything we do, and concentrating on the engagement and development of self and peers.
Role Functions (Functions include, but are not limited to, the following)
OP - level O1:
* Support operations team to deliver specific Key Performance Indicators (KPIs), such as Environmental Health and Safety (EHS) metrics, Production Plan, Overall Equipment Effectiveness (OEE), compliance, and team training.
* Complete COMMIT cards to highlight ways of working within our SDWT's and Hubs that support our COMMIT culture.
* Provide immediate feedback to reinforce good safety and improvement behaviors.
* Execute manufacturing processes according to established work instructions and Standard Operating Procedures (SOPs).
* Ensure that all assigned tasks related to manufacturing documentation support are in accordance with good manufacturing practices.
* Work as part of a dedicated process team where flexibility and teamwork are key.
* Generate SOPs/ Work Instructions (WIs) to ensure compliance with regulatory standards.
* Adhere to Right First-Time principles.
* Provide assistance to maintenance, engineering, quality or other colleagues as requested.
* Maintain a high level of expertise and working knowledge of all aspects of the manufacturing process and process equipment.
* Challenge and identify improvements to the safety and environmental programs on site.
* Celebrate with proactive recognition tools that inspire teams and individuals you collaborate with.
* Take part in shift handovers and tier 1 meetings, raising concerns or issues promptly and providing options for resolutions.
* Act as an ERT during emergency situations if trained.
OP - Level O2 responsibilities:
- Maintain high safety and GMP compliance standards
- Use past experiences to solve problems
- Participate in inspections, GEMBA's, and Go-See's
- Contribute to process deviation reviews and Gemba walkdowns
- Mentor new staff
- Answer auditor questions during site walkdowns
- Implement innovative solutions for high performance
- Use Lean Six Sigma Tools for continuous improvement
Level O3 Responsibilities:
Participate in internal audit programs and risk assessment compliance activities.
- Coach shift teams on RFT documentation and Client Production systems skill transfer.
- Utilize real-time data analytics for value stream improvement initiatives. - Lead and participate in investigations and troubleshoot issues. - Promote EHS leadership behaviors and a culture of safety.
- Confirm completion of activities by end of shift.
- Act as a Cell Lead and be responsible for a unit operation. Additionally, any other duties as assigned by the Manager.
Experience, Knowledge & Skills
General Competencies:
OP - level O1:
* Demonstrate successes in a team environment in either a project or work-related activities.
* Demonstrate troubleshooting competency.
* Desire to learn and develop.
OP - level O2:
The general competencies listed at O1 level plus:
* Ability to interact with multiple stakeholders across numerous departments.
* Excellent communication skills.
* Ability to manage multiple priorities and know when to escalate issues for resolution.
* Excellent trouble shooting skills as well as an ability to coach and mentor self-directed teams through complex problem solving.
OP - level O3:
The general competencies listed at O2 level plus:
* High degree of problem-solving ability and adherence to scheduled timelines.
* A proven ability to lead cross-functional teams and deliver on tight timelines.
Technical:
OP - level O1:
* Understanding of Drug Substance Manufacturing Operations.
* Understanding of GMP requirements in a Biopharmaceutical Facility.
* Excellent communication skills and the ability to work in a cross-functional collaborative environment.
OP - level O2:
The technical competencies listed at O1 level plus:
* Knowledge of applying Lean Six Sigma and Lean methodologies in a workplace environment.
* Possess a detailed overview of the overall upstream/ downstream process, with expertise and knowledge of the manufacturing process.
OP - level O3:
The technical competencies listed at O2 level plus:
* Maintain a high level of expertise and working knowledge of the process equipment.
* Can lead and deliver cross-functional Operational Excellence projects/ Initiatives.
* A proven ability to work with automated systems such as Manufacturing Execution System (MES),
Systems Applications and Products (SAP), Delta V etc.
Qualifications & Education
OP - level O1:
* Level 7 qualification in a science or engineering discipline, or level 6 with a minimum of 1 - 3 years' experience in a GMP Manufacturing environment.
OP - level O2:
The minimum education/ experience listed at O1 level (3 years) plus:
* Experience of Upstream/ Downstream Processing.
* Experience in a highly regulated pharmaceutical manufacturing environment.
* Proven record of accomplishments in a regulated industry.
OP- level O3:
The minimum education/ experience listed at O2 level (4 years) plus:
* Start-up experience in a large-scale commercial drug substance facility or similar.
This role is a site-based role.
* This role will involve working shifts on a 24/7 basis.
