Senior Fill Finish Process Engineer

Biogen

Athlone

On-site

EUR 90,000 - 120,000

Full time

5 days ago
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Job summary

Biogen in Athlone seeks a Senior Fill Finish Process Engineer to lead aseptic fill-finish operations, provide lifecycle engineering for sterile drug product systems, and drive capital projects and operational readiness on site.

You will act as the on-site Global Engineering & Facilities representative, coordinating with global authorities, assessing facility needs, supporting design reviews, and guiding technology deployment to improve capacity, reliability, and compliance.

Qualifications

  • Bachelor's degree in Mechanical, Chemical, Industrial, Pharmaceutical, or related Engineering.
  • Experience in pharmaceutical/biotech regulated manufacturing.
  • Experience in aseptic manufacturing operations and sterile processing technologies.
  • Experience with facility fit assessments, engineering evaluations, and feasibility studies.
  • Experience supporting capital projects and facility changes.

Responsibilities

  • Lead aseptic fill-finish projects and identify process improvements.
  • Provide lifecycle engineering for drug product systems throughout their life cycle.
  • Support technical due diligence, process evaluations, and network assessments.
  • Coordinate with site engineering and operations to expand capacity and deploy technology.
  • Ensure GMP and safety requirements are met across projects.

Skills

Sterile manufacturing
Aseptic processing
Capital project leadership
Engineering leadership

Education

Bachelor's degree in Mechanical, Chemical, Industrial, Pharmaceutical Engineering

Job description

About This Role

The Senior Fill Finish Process Engineer is a site-based member of the Global Engineering & Facilities within the Drug Product Engineering Technical Authority. The role provides technical leadership for aseptic fill-finish and sterile drug-product manufacturing systems, with accountability spanning facility-fit assessments, feasibility studies, front-end capital planning, engineering design, project execution and operational readiness.

As the primary GEF interface at the Athlone site, the position connects site stakeholders with Biogen's Global Engineering Technical Authorities and coordinates the appropriate discipline support for capital projects, technical assessments and operational priorities. The engineer applies lifecycle-based engineering practices to ensure that facilities, equipment and systems are safe, compliant, reliable, scalable and aligned with Biogen standards and long-term manufacturing strategy.

What You'll Do
Aseptic Manufacturing & Drug Product Engineering

Serve as a Subject Matter Expert (SME) for aseptic filling, sterile manufacturing processes, isolators, RABS, lyophilization, autoloading systems, and associated drug product technologies.

Provide engineering leadership and technical guidance for drug product manufacturing systems throughout their lifecycle.

Support technical due diligence, process evaluations, and manufacturing network assessments.

Partner with site engineering and operations teams to identify opportunities for process improvements, capacity expansion, and technology deployment.

Facility Fit & Feasibility Studies

Lead Facility Fit Assessments for new products, technologies, and manufacturing opportunities.

Develop and execute feasibility studies for facility modifications, capacity expansion projects, and new manufacturing investments.

Evaluate process, equipment, utility, infrastructure, automation, and facility requirements to support informed project decisions.

Support business case development and capital planning activities.

Capital Projects & Engineering Design

Support the development and execution of capital projects from concept through operational readiness.

Collaborate with Engineering & Architectural (A&E) firms during feasibility, conceptual design, FEED, detailed design, and construction activities.

Review engineering deliverables including layouts, process flow diagrams, equipment specifications, utility assessments, and design packages.

Ensure projects align with Biogen engineering standards, GMP requirements, and long-term technical strategies.

Provide technical leadership during project reviews, design workshops, and stage-gate governance activities.

Site Technical Authority Representation

Act as the on-site representative for Global Engineering & Facilities.

Provide local coordination and support for Drug Product, Facilities, Automation, and other Technical Authority functions as required.

Facilitate communication and alignment between global technical authorities and site stakeholders.

Support engineering investigations, technical assessments, and site operational issues as required.

New Opportunities

Support assessments of other future modalities as required - finished goods, packaging, assembly, labeling, and related manufacturing opportunities.

Participate in strategic evaluations for future facility expansions and capability development.

Provide engineering support for technology transfers and implementation of new manufacturing platforms.

Technology & Innovation

Monitor industry trends, emerging technologies, and best practices in aseptic processing and pharmaceutical manufacturing.

Support development and deployment of engineering standards, specifications, and best practices.

Partner with vendors, equipment suppliers, and industry experts to identify innovative technical solutions.

Drive continuous improvement and engineering excellence across the manufacturing network.

Who You Are

You are a highly capable engineering professional with strong experience in sterile pharmaceutical manufacturing, facility design, and capital project execution. You apply sound engineering judgement to complex and sometimes ambiguous problems, translate technical risks into practical recommendations, and influence decisions across site, global and external stakeholders

You are comfortable influencing stakeholders across all organizational levels and can effectively represent Global Engineering & Facilities within a manufacturing site environment.

Required Qualifications
  • Bachelor's degree in Mechanical, Chemical, Industrial, Pharmaceutical, or related Engineering discipline.
  • Engineering experience within the pharmaceutical, biotechnology, medical device, or related regulated manufacturing industries.
  • Experience supporting aseptic manufacturing operations and sterile processing technologies.
  • Experience with facility fit assessments, engineering evaluations, and feasibility studies.
  • Experience supporting capital projects and facility
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