Process Engineer – External Manufacturing Drug Substance

Location: Louth, Ireland
Travel Requirement: Approximately 25%

Shape the Future of Biopharmaceutical Manufacturing
Are you a motivated Process Engineer looking to make an impact in the pharmaceutical industry? Join a global leader and play a pivotal role in ensuring seamless manufacturing operations through cutting-edge technology transfers and commercial production of Large Molecule Drug Substance. Be part of a dynamic team focused on innovation, continuous improvement, and world-class engineering solutions. Based in Louth, you’ll work closely with External Partners (EPs) to optimise processes and contribute to life-saving therapies.

Key Responsibilities

• Collaborate with External Partners:
  Partner with External Manufacturing sites to meet business objectives, fostering a shared culture that prioritises innovation, compliance, and patient needs.

• Process Improvement & Manufacturing Support:
  Lead technical activities related to the commercial manufacturing process, including authoring change control documents, managing process improvement projects, performing statistical analysis, and investigating deviations and atypical events.

• Technology Transfer:
  Manage and support technology transfers, including authoring and reviewing essential GMP documentation (Master Batch Records, change controls, protocols, and regulatory filings) to ensure flawless execution of tech transfer projects.

• On-Site Process Support:
  Provide on-site coverage at External Partner facilities to support commercial production and tech transfer activities. Engage in real-time troubleshooting and process optimisation.

• GMP & Compliance Expertise:
  Ensure that processes meet Good Manufacturing Practice (GMP) standards by developing and implementing standardised work practices. Collaborate with Operations, Quality, and External Partners to maintain inspection readiness for routine and new product introduction audits.

• Drive Continuous Improvement:
  Contribute to the adoption of best practices and innovative strategies that drive process optimisation and operational excellence. Participate in and lead improvement initiatives to enhance overall production efficiency.

Skills & Qualifications

• Education:
  Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Pharmaceutical Science, or a related field.

• Experience:
  At least 4 years of experience in a GMP manufacturing environment, with a strong focus on technical transfer, process optimisation, or technical operations. Drug Substance Technical Transfer experience is essential.

• Communication & Leadership:
  Excellent communication, teamwork, and project management skills. Demonstrated ability to manage projects independently and meet tight deadlines.

• Technical Expertise:
  Hands-on experience in biologics drug substance operations (upstream and downstream), process development, statistical analysis, and deviation/change management.

• Preferred Experience:
  Proven experience in statistics, Proactive Process Analysis, and Continuous Process Verification. Expertise in deviation management, change control, and equipment/process troubleshooting.

Why Louth?
Located in the heart of Ireland, Louth offers an exceptional quality of life, combining rich history with beautiful landscapes and a welcoming community, perfect for both career growth and life outside of work.

If you're passionate about making a difference and want to work at the forefront of biopharmaceutical innovation, this Process Engineer role in Louth could be the next step in your career!

For further information on this role, please contact Diarmuid Lannon on +353 861287246 or email consulting@hero.ie Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

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Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.