Search Jobs
Principal Technical Support Specialist based in Dundalk
Dundalk Science and Technology Park Mullagharlin Dundalk, Louth A91 A4CC IE
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.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
Share This Job:
Related Jobs:
Are you sure you want to apply for this job?
Please take a moment to verify your personal information and resume are up-to-date before you apply.