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Technology Transfer and Commercialization Subject Matter Expert
Primary responsibilities include but are not limited to:
1. Support operations team to consistently deliver on specific Key Performance Indicators (KPIs), e.g. Environmental Health and Safety (EHS) metrics, Production Plan, Overall Equipment Effectiveness (OEE), compliance, and team training.
2. Complete COMMIT cards to highlight ways of working within our SDWT’s and Hubs and across our site that support our COMMIT culture.
3. Provide immediate feedback to others at any time to reinforce good safety and improvement behaviors and acts.
4. Execute commercial manufacturing processes according to established work instructions and Standard Operating Procedures (SOPs).
5. Ensure that all assigned tasks related to manufacturing documentation support are in accordance with good manufacturing practices.
6. Routinely talk about any safety issues you are concerned about.
7. Work as part of a dedicated process team where flexibility and teamwork are key requirements.
8. Generate SOPs/Work Instructions (WIs) to ensure compliance with regulatory standards.
9. Adhere to Right First-Time principles.
10. Provide assistance and/or support maintenance, engineering, quality, or other colleagues as requested. Escalate issues as appropriate to manager/designee.
11. 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.
12. Liaise with other groups and individuals to ensure planning of tasks is effective and linked into the manufacturing process plan and site schedule.
13. Challenge and identify improvements to the safety and environmental programs on site.
14. Celebrate with the use of proactive recognition tools that inspire teams and individuals you collaborate with.
15. Take part in shift handovers and tier 1 meetings, raising concerns or issues promptly and providing options for resolutions.
16. Act as an ERT during emergency situations if trained.
Experience, Knowledge & Skills
General Competencies:
1. Demonstrate successes in a team environment in either project or work-related activities.
2. Demonstrate troubleshooting competency.
3. Desire to learn and develop.
Technical:
1. Understanding of Drug Substance Manufacturing Operations.
2. Understanding of GMP requirements in a Biopharmaceutical Facility.
3. Excellent communication skills and the ability to work in a cross-functional collaborative environment.
Qualifications & Education
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 or trade background. OR Leaving Cert with relevant experience. 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 4-cycle, 24/7 basis.
Seniority level
* Entry level
Employment type
* Contract
Job function
* Management and Manufacturing
* Industries: Pharmaceutical Manufacturing
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