Drug Product Operations Process 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.

• Conduct Impact Assessments and Risk Assessments for new or modified systems;

• Draft User Requirements Specifications (URS) to support project and compliance needs;

• Contribute to Enhanced Design Reviews, ensuring alignment with technical and regulatory standards;

• Develop and execute Design Qualification (DQ) protocols;

• Lead the execution of Commissioning activities and protocols;

• Generate and carry out Installation Qualification (IQ) protocols;

• Implement Operational Qualification (OQ) protocols in line with project requirements;

• Perform Performance Qualification (PQ) protocols to verify process capability;

• Support the commissioning and qualification of equipment, utilities, and systems (e.g., HVAC, production equipment, formulation equipment, pharmaceutical water systems, nitrogen, clean compressed air, QC equipment);

• Collaborate with cross‑functional teams to ensure smooth and compliant project execution throughout the equipment lifecycle.

• Bachelor's degree or higher in engineering or a related field;

• Experience in commissioning, qualification, and validation in the pharmaceutical or life sciences industries in valued;

• Knowledge of industry regulations and standards (e.g. FDA, PIC/S, EMA, GAMP 5, ISPE);

• Project Management, strong analytical and problem-solving skills;

• Excellent written and verbal communication skills;

• Ability to work effectively in cross-functional teams;

• Attention to detail and strong organizational skills;

• Experience with facilities, utilities, systems, and equipment qualification is a must;

• Experience with computerized systems validation is a plus;

• Passion for on-field work.

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.

Notice to Agencies and Search Firms Representatives

Hovione does not accept unsolicited resumes from agencies or search firms for this job posting. Any resumes submitted to Hovione by a third-party agency or search firm without a valid written and signed search agreement will become the sole property of Hovione. No fees will be paid if a candidate is hired for this position as a result of an unsolicited referral.