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Viatris

Global pharma selling generics and biosimilars

Technical Services Lead

Bioprocess & BiomanufacturingUpdated on Nov 11
Full-timeMinna, Inverin, Co. Galway, IrelandIn-person

About the Job

Requirements

  • A Bachelor's or Master's degree in Pharmaceutical Science, Chemical Engineering, Biochemical Engineering, or a related field.
  • Experience in pharmaceutical process development, technical services, or manufacturing, ideally in sterile injectables.
  • Strong knowledge of aseptic processing, process validation (PPQ), and scale-up.
  • Experience with design of experiments (DOE), statistical process control (SPC), and process modeling tools such as Minitab.
  • Deep understanding of critical process parameters (CPPs), critical quality attributes (CQAs), and control strategy design.
  • Knowledge of microbiological principles and sterility assurance.
  • Ability to lead cross-functional teams and deliver complex technical projects.

Responsibilities

  • Support delivery of the 3-year commercialization program for a new cartridge-filling product line, focusing on product and process performance and the design, development, transfer, and optimization of aseptic pharmaceutical manufacturing processes while ensuring compliance with current Good Manufacturing Practice (cGMP) and global regulatory expectations.
  • Lead process validation (PPQ) and ongoing process verification activities for sterile drug products.
  • Ensure product- and process-related technical services align with regulatory and internal standards.
  • Lead the design, development, and optimization of aseptic manufacturing processes for robustness, scalability, and efficiency.
  • Define critical process parameters (CPPs) and critical quality attributes (CQAs) for manufacturing processes.
  • Initiate and lead process risk assessments using failure mode and effects analysis (FMEA), Ishikawa diagrams, and other methods, and implement risk mitigation strategies.
  • Analyze process and performance data to identify trends, reduce variability, and improve yield.
  • Support investigations, root cause analyses, and corrective and preventive action (CAPA) implementation for process deviations or non-conformances.
  • Lead technical aspects of scale-up, technology transfer, and commercialization of new products.
  • Collaborate with Research and Development, Manufacturing, Quality, Engineering, and Regulatory Affairs to support transitions from development to commercial production.
  • Provide subject-matter-expert input into process validation protocols, batch records, and regulatory documentation.
  • Identify qualification and validation requirements for new product introductions.
  • Stay current with evolving regulatory expectations, including Annex 1, FDA, EMA, and ICH Q8–Q10, and integrate best practices into process management.
  • Ensure completion of PPQs, transfers, and process improvement projects within agreed timelines.
  • Maintain zero critical or major audit findings related to process validation or robustness.
  • Demonstrate measurable gains in process consistency, quality, and productivity.

Desired Qualifications

  • Project Management certification would be an advantage.

About the Company

Viatris

Global pharma selling generics and biosimilars

Viatris is a global pharmaceutical company that provides access to medicines through a diverse portfolio of branded drugs, generics, complex generics, and biosimilars, serving patients in more than 165 countries. Medicines are produced and distributed via Viatris's extensive global supply chain and commercial network, making therapies available across cardiovascular, infectious diseases, immunology, and oncology. The company differentiates itself with a large, diversified product mix, broad international reach, and a focus on access and public health rooted in the Mylan-Upjohn lineage. Its strategy combines organic growth with partnerships and acquisitions to expand patient access while pursuing sustainable operations.

Company size
10,001+
Company stage
IPO
Headquarters
Canonsburg, PA
Founded
1961

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