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Hovione

Senior Process Engineer - API Chemistry

19h

Hovione

Cork, IE · Full-time · €70,000 – €95,000

About this role

Hovione is an independent family-owned international CDMO and market leader in innovative pharmaceutical manufacturing. We help customers bring new and off-patent drugs to market through advanced technological capabilities. Our 1950 team members from 36 nationalities drive success across Asia, Europe, and North America.

As Senior Process Engineer, enable efficient manufacture of pharmaceutical products, including highly potent compounds, in cGMP and HSE compliance. Define, implement, and optimize processes to meet schedules, manage resources, and fulfill customer requirements. Plan manufacturing for reliable, right-first-time production of intermediates and finals within budget.

Coordinate new procedures, enforce GMP and HSE policies, and support inspections across areas. Act as lead engineer on high-complexity projects, liaising directly with customer teams for transparent communication. Oversee less experienced engineers, providing training on processes and systems.

Manage risks, deviations, and CAPAs autonomously to prevent goal deviations. Prepare and approve critical documentation like batch records, validation reports, and change controls. Join a culture reaching for innovation and excellence—for clients, partners, and patients—in it for life.

Requirements

  • Expertise in API chemistry manufacturing processes and scale-up
  • In-depth knowledge of cGMP regulations and HSE policies for pharmaceuticals
  • Experience handling highly potent compounds in production
  • Proficiency in process optimization, resource allocation, and schedule management
  • Skilled in risk assessment, deviation investigation, and CAPA implementation
  • Ability to prepare and approve GMP documentation including batch records and validation reports
  • Strong capabilities in leading complex projects and customer liaison

Responsibilities

  • Enable the efficient manufacture of pharmaceutical products, including highly potent compounds, in compliance with cGMP and HSE regulations
  • Define, implement, and optimize manufacturing processes and systems to adhere to schedules and customer requirements
  • Plan and design manufacturing processes ensuring reliable production of intermediates and final products on time and within budget
  • Prepare, review, and approve manufacturing documentation including batch records, campaign reports, validation plans, and change controls
  • Supervise, execute, and ensure risk assessments for assigned activities and projects
  • Report, investigate, and document deviations, non-conformances, and implement CAPAs
  • Act autonomously as lead process engineer in high-complexity projects and liaise with customer teams
  • Provide training on manufacturing processes and oversee less experienced engineers

Benefits

  • Work in a family-owned international group with 4 production sites worldwide
  • Join a diverse team of 1950 members from 36 nationalities
  • Pursue innovation and excellence in pharmaceutical development for patients