Engineering Director, Pharmaceutical Ops & Compliance

Biopharma Careers; Inverin; Sur place; EUR 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

Health insurance

Pension

Bonus scheme

Work-life balance initiatives

Résumé du poste

Viatris is a global healthcare company focused on bridging generics and brands to improve access to medicines worldwide, with a commitment to building a diverse and inclusive workplace. Viatris seeks an engineering leader to drive multi-year capital strategies, ensure regulatory compliance, and lead cross-functional teams across site infrastructure, validation, and continuous improvement.

The role emphasizes leadership in pharmaceutical engineering, sterile manufacturing knowledge, and adherence

Qualifications

• Extensive plant engineering leadership experience in the pharmaceutical industry with knowledge of sterile drug manufacture and cGMP requirements.
• Strong understanding of Annex I, US and EMA GMP regulations, with practical experience in regulatory audits (HPRA, FDA).
• Experience in aseptic process and contamination control strategies, including cleaning and disinfection validation.
• Demonstrated ability to plan, design and manage significant capital expansion projects, with equipment qualification, validation and facilities upgrades.
• Strong people leadership skills with a proven track record of building high-performing, multidisciplinary teams.

Responsabilités

• Lead, mentor and develop multidisciplinary maintenance, engineering and facilities teams.
• Develop and execute multi-year engineering and capital investment strategies to support capacity, compliance and business growth.
• Drive engineering reliability, asset lifecycle management, preventive maintenance and technical problem-solving across site infrastructure.
• Develop, implement and promote a Reliability Centred Maintenance (RCM) strategy using FMECA/FMEA assessments, trend analysis and control charts.
• Oversee validation and qualification protocols (IQ, OQ, PQ) for pharmaceutical manufacturing equipment and facilities.
• Ensure full compliance with HPRA, FDA, GMP, cGMP, ISO and other global regulatory standards, supporting inspections and maintaining audit-ready operations.
• Manage annual and multi-year capital budgets, overseeing capital projects and facility upgrades to deliver cost-effective, sustainable solutions.
• Partner closely with Manufacturing, Quality, Supply Chain and MS&T teams to align on operational needs and drive sustainability initiatives.

Connaissances

Engineering leadership

cGMP compliance

Regulatory audits

Aseptic processing

Capital project management

Six Sigma Black Belt

Formation

Bachelor’s or Master’s in Engineering

Description du poste

Viatris is a global healthcare company focused on bridging generics and brands to improve access to medicines worldwide, with a commitment to building a diverse and inclusive workplace. Viatris seeks an engineering leader to drive multi-year capital strategies, ensure regulatory compliance, and lead cross-functional teams across site infrastructure, validation, and continuous improvement.

The role emphasizes leadership in pharmaceutical engineering, sterile manufacturing knowledge, and adherence