Senior Process Development Engineer

5 days ago

Dún Laoghaire, Dún Laoghaire-Rathdown, Ireland beBeeEngineering Full time €90,000 - €120,000

Technical Lead Job Opportunity

We are seeking a seasoned technical expert to lead process development initiatives and teams. This role offers an opportunity to contribute to team development and technical leadership in a dynamic environment.

Key Responsibilities:

  • Providing technical expertise in sterile drug product unit operations, including formulation, vial filling, pre-filled syringe filling, lyophilization, and vial capping.
  • Leading and coaching process development teams, fostering technical development and supporting team growth.
  • Leading or contributing significantly to product and process investigations, including root cause analysis and product impact assessments.
  • Acting as a subject matter expert during change control, assessing the impact of proposed changes on the product and process performance.
  • Supporting new product introductions (NPI), including recipe and protocol development, batch execution support, and troubleshooting.
  • Driving continuous improvement initiatives to enhance process capability, reduce variability, and improve productivity.
  • Analyzing manufacturing data trends to identify opportunities for improvement and prevent potential issues.
  • Reviewing and approving GMP documentation, such as SOPs, electronic batch records, and product technical documentation.
  • Collaborating with cross-functional and global teams to ensure alignment and execution of strategies.

Requirements:

  • Bachelor's or Master's degree in Engineering, Science, or related discipline, or PhD with relevant experience.
  • Demonstrated leadership skills, ability to build teams, and operate across functional boundaries.

Preferred Qualifications:

  • Typically 6+ years of drug product experience in areas such as drug product formulation, vial/pre-filled syringe filling, or lyophilisation.
  • Strong leadership capabilities, with experience guiding teams or technical initiatives and supporting team development.
  • Demonstrated experience in parenteral drug product manufacturing and delivery of complex technical projects.
  • Strong problem-solving technical skills related to parenteral drug product manufacturing.
  • Thorough knowledge of GMP biotechnology manufacturing and significant understanding of cGMPs.

What We Offer:

This role offers a unique opportunity to develop your technical expertise and leadership skills in a fast-paced environment. You will be working with a talented team of experts, collaborating on cutting-edge projects, and driving innovation in the field of pharmaceutical manufacturing.

About Us:

Our company is a leading player in the pharmaceutical industry, committed to delivering high-quality products and services to our customers. We value innovation, teamwork, and customer satisfaction above all else.

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