Drug Product Operations Support Process Engineer

Drug Product Operations Support Process Engineer

Hovione

Loures, Portugal

You will be responsible to:

• 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.

We are looking to recruit a Candidate:

• 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.