Drug Product Operations Support Process Engineer

At Hovione, we help partners turn scientific innovation into medicines that reach patients around the world. For more than 65 years, we have connected science and technology to scale complex ideas into high-quality and innovative solutions that truly make a difference.

As an international Contract Development and Manufacturing Organization (CDMO), we support the development and manufacture of drug substances, intermediates and drug products across the full life cycle. We are globally recognized for our leadership in specialized technologies such as Spray Drying and Continuous Tableting. But what truly sets us apart is not just what we do — it is how we do it: with purpose, care, collaboration and a deep commitment to doing the right things right.

Our people are the reason for our success. We are a global and diverse team of more than 2,600 team members across Europe, the USA and Asia, bringing together different experiences and perspectives to help our partners to overcome complex challenges. We believe that an inclusive environment — where everyone, regardless of background, identity or ability, is respected, heard and empowered to contribute — is essential to drive innovation, ensure quality, and secure long‑term sustainable success.

And as we grow, so do the opportunities for our people to develop, broaden their perspectives and build meaningful careers. Because at Hovione, better starts with those who choose to make a difference every day. Will you be one of them?

• 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. We are committed to creating an inclusive recruitment experience and welcome applications from all qualified candidates. If you require any reasonable accommodation or support during the application or interview process, please contact us, and we will be happy to assist.

Notice to Agencies and Search Firms Representatives

Hovione does not accept unsolicited résumes 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. Thank you for your understanding.