Sr. Spclst, Operations, Tech Supply

Job Description

A fantastic opportunity has arisen for a Sr. Spclst, Operations, Tech Supply.

Reporting into the Biotech Dublin Upstream Technical Operations Lead, the Senior Specialist, Operations will be a key technical subject matter expert ensuring the facility is operationally ready for commercial large-scale production of Drug Substance.

The role will deliver a diverse range of technical support to the Drug Substance Business. This will include leading technical investigations within the Integrated Process Team and supporting significant projects across the site.

Bring energy, knowledge, innovation to carry out the following:

1. Work with the Integrated Process Team (IPT) to ensure the effective and efficient on-time delivery of batch production within the IPT area.
2. Establish oneself as a key point of contact for designated upstream process workstreams as assigned.
3. Provide ongoing coaching to cross functional team members, to share process, engineering, and maintenance best practices.
4. Provide technical, process and engineering expertise within a wide range of projects, such as the introduction of new equipment and processes.
5. Work with Technical groups across the site and network, foster technical excellence to be a differentiating advantage.
6. Support Upstream Operations teams to consistently deliver on specific area Key Performance Indicators (KPIs), e.g. Safety metrics, Production Plan, Overall Equipment Effectiveness, compliance and team training.
7. Author and manage Deviation and Change Control generation.
8. Assist in the investigation and troubleshooting of issues and the development and implementation of robust corrective and preventative actions.
9. Review trends for CAPA Effectiveness.
10. Coach, and help develop a pool of investigators within the Upstream IPT.
11. Support generation of SOPS/Electronic Batch Records for production and facilitate reviews as necessary.
12. Accountable for protocol generation, report authoring, execution, oversight and approval.
13. Participate in site audits as deemed necessary.
14. Drive a culture of Continuous Improvement by deploying Six Sigma and lean manufacturing tools.

What skills you will need:

In order to excel in this role, you will more than likely have:

1. Degree or 3rd level qualification (Science, Engineering).
2. At least 8+ years experience in the Pharmaceutical industry (preferably experience in Drug Substance, Upstream operations).
3. Experience in a highly regulated GMP Manufacturing Environment in a technical or manufacturing support role.
4. Knowledge and experience in process optimization, technical transfer of products and extensive knowledge of Validation requirements.
5. Demonstrated leadership and change management skills with a continuous improvement focus.
6. Proven track record of delivering high performance through development and coaching of a team.
7. Demonstrated excellent problem solving capabilities.
8. Knowledge of and experience in applying Six Sigma and Lean methodologies.
9. Desirable evidence of Continuous Professional Development.

As a company, we are committed to 'Inventing for Life' in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, please apply today.

Requisition ID:R341103