Senior Automation Engineer

Hovione is an independent family owned international group of companies. From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market.

Our people are the main asset for our continued success. Reaching over 1950 team members, from 36 different nationalities, that are located across Asia, Europe and North America (Portugal, US, Macao, Ireland, China, Hong Kong, Japan, India, and Switzerland), including 4 production sites.

Working at Hovione means reaching for innovation and excellence in everything we do: for our clients, our partners and, above all, our patients. That is why we are In it for life.

• Contribute to the development and periodic revision of automation standards, SOPs, and technical guidelines; take ownership of specific technical areas within the Body of Knowledge. 
• Review new automation projects for compliance with internal standards and regulatory expectations; provide formal feedback and mentor project engineers on best practices. 
• Act as a senior reference for automation standards, supporting internal teams and external partners in consistent and effective implementation. 
• Deliver expert guidance and technical support for resolving complex automation challenges, drawing on standards and past experiences to drive effective solutions. 
• Lead readiness activities for regulatory inspections and internal/client audits in the automation scope, by ensuring standards are followed, deviations justified, and documentation ready. 
• Interface with Quality Assurance, IT/Digital, and Manufacturing to ensure automation practices align with requirements such as data integrity (e.g., 21 CFR Part 11), cybersecurity, and operational workflows. 
• Mentor and coach junior and mid-level engineers in understanding the intent, structure, and practical use of the Body of Knowledge; promote a culture of technical excellence and regulatory compliance. 

- University degree, or equivalent qualification in Engineering (Mechanical, Electrical, Civil) or similar scientific field (mandatory)

- Candidate will typically have at least 10 years of extensive experience in installation management or equipment qualification, preferably with a focus in chemical plants or Pharmaceutical industry

- Training and experience of GMP and HSE practices (mandatory) 

- Advanced knowledge of legislation applicable to engineering projects and quality requirements applicable to technical installations.

- Advanced knowledge of equipment (Mechanical, E&I), of Quality, cGxPs, ICH, ISPE and ISO guidelines as well as experience on their application.

- Ability to respond to audits

- Fluency in written and verbal English  

- Computer literate with good working knowledge of the MS Office package

- Strong knowledge of legislation applicable to engineering projects and GMP compliance 

- Proven experience with control systems (PLC, SCADA, DCS), software validation, alarm management, and network architecture 

- Ability to respond to audits and represent the automation scope during regulatory inspections 

- Proficient with MS Office and CAD tools; familiarity with version control and digital design tools preferred 

- Must demonstrate ability to independently perform and document technical tasks in line with internal procedures and external regulations 

Hovione is a proud Equal Opportunity Employer

Inclusion and diversity are key to us. At Hovione, that means a work environment where differences are valued, and everyone is treated with fairness and respect. We want all our team members worldwide to feel supported, respected, and have the opportunity to achieve their full potential, regardless of their age, gender, religion, disability, sexual orientation or ethnicity.