Automation Engineer- API ( pharma)

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.

This role can be based out of any of our manufacturing sites or remotely in the follwoing regions- Cork ( Ireland), New Jersey, Macau and Lisbon.

• Design, project coordinarion and execution/qualification of strategic projects across all sites as part of the Global Engineering team;

• Performs automation and qualification activities on facilities, equipment and utility systems, according to regulatory demands (cGMP, GAMP, FDA requirements, etc), industry applicable guidelines and internal procedures;

• Planning, executing and supervising new or business continuity projects (MS Project, Meeting project deadlines and operation targets, milestones);
• Prepare Project Budgets and Coordinate outside contractors working on facility projects;
• Proactively develop, maintain, drive and communicate project timelines to broader cross-functional team on a weekly basis.

• Subject Matter Expert / minimum of 2 years of industry experience;
• Equipment Qualification (Pharma, Chemical, Oil&Gas, Food);
• Equipment automation design (user interfaces, control logic, alarms and interlocks);
• Participating in Design Reviews, FMEA and HAZOP meetings;
• Anticipates and/or develops/applies Risk Mitigation (Reviews engineering technical risks and take appropriate action to Improve Safety, Quality and Efficiency of Industrial Operations);
• Documenting and managing change (Justifies changes, quality and regulatory information, and manufacturing readiness information);
• Qualification / Validation Protocols and Summary Reports;
• Traceability Matrix;
• Participate in Equipment commissioning and qualification activities (e.g., FAT, SAT, IQ, OQ) and conduct verification activities as required by site change control program;
• Provide automation guidance and training to other functional groups (e.g., Operations, Validation, Maintenance, etc.);
• Continuous improvement in the current Automation strategy and equipment optimization;
• Requires prior experience performing validations of systems and equipment in a time-sensitive projects;
• Strong technical knowledge of process control manufacturing techniques;
• Knowledge of requirements for design, installation, commissioning, qualification and validation of pharmaceutical equipment, systems and utilities using risk-based approaches;
• Knowledge of leveraging test data from early stage project testing into later stages (e.g. FAT into SAT/IOQ);
• Knowledge of regulatory validation requirements including FDA, EMA and all other applicable worldwide Regulatory requirements (ICH Q7, Q8, Q9);
• Team spirit, initiative, dynamism, flexibility and creativity;
• Available to work on-call, in short term shift work and international travels.

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.