Job Description
Principal Technical Support Specialist Based in County Louth, Ireland
Join a dynamic and innovative team at the forefront of pharmaceutical manufacturing as our Principal Technical Support Specialist. This pivotal role offers an exciting opportunity to lead technical initiatives, support manufacturing excellence, and drive continuous improvement projects in a fast-paced, regulated environment. If you are a seasoned professional with a passion for technical leadership and a proven track record in sterile drug product manufacturing, this is your chance to make a significant impact.
What You Will Do
* Provide technical leadership across formulation, filling, lyophilisation, capping, and automated visual inspection operations.
* Oversee and execute equipment qualification deliverables, including commissioning, IQ/OQ, and validation projects.
* Develop, review, and revise critical technical documents such as SOPs, batch records, protocols, and risk assessments.
* Support day-to-day manufacturing operations, including batch disposition and root cause analysis of deviations.
* Lead and participate in manufacturing investigations, ensuring effective CAPA implementation.
* Drive process and quality improvements utilizing Lean Six Sigma methodologies.
* Represent the site during regulatory, internal, and client audits.
* Collaborate closely with cross-functional teams, including MS&T scientists and operations staff, providing expert technical guidance.
* Take on delegated responsibilities from the Manufacturing Technical Lead, ensuring seamless project execution.
Required Skills
* Minimum of 5 years experience in biological, vaccine, or pharmaceutical manufacturing, with solid knowledge of cGMP standards.
* Proven expertise in sterile manufacturing processes, including equipment qualification, validation, and troubleshooting.
* Strong technical investigation skills supported by data-driven root cause analysis and continuous improvement initiatives.
* Familiarity with risk assessment tools such as FMEA.
* Excellent communication skills, with the ability to articulate complex technical concepts to diverse audiences.
* Ability to operate effectively within a matrix team environment, managing multiple priorities.
Nice To Have Skills
* Experience with lyophilized products and start-up manufacturing facilities.
* Knowledge of USP1790, industry regulations, and Annex 1 compliance.
* Background in operational roles within vaccine manufacturing.
* Experience with startup environments and regulatory inspections.
* Skills in Lean Six Sigma methodology and process optimization.
Preferred Education And Experience
* Bachelor's degree in Engineering, Science, or Technology-related discipline.
* Deep understanding of sterile product manufacture, validation, and quality systems.
* Extensive hands-on experience in a biotech, vaccine, or pharmaceutical GMP facility.
Other Requirements
* Fully on site in County Louth, Ireland; no WFH arrangements.
* Strong organizational and planning skills.
* Ability to work collaboratively and adapt to changing project demands.
* Willingness to participate in audits and technical reviews as an essential team member.
Take this opportunity to elevate your career by bringing your expertise to a company committed to innovation and excellence. If you are ready to lead technical excellence in a vital manufacturing environment, we encourage you to apply now and be part of a pioneering team shaping the future of healthcare.
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.