Automation CQV/CSV 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.

• Develop and execute commissioning, qualification, and validation protocols (DQ, IQ, OQ) for automation and control systems;
• Ensure compliance with GMP, GAMP 5, and 21 CFR Part 11 during all phases of system implementation and operation;
• Author and maintain validation documentation, including protocols, reports, and traceability matrices for computerized systems;
• Conduct risk assessments and impact analyses to determine validation scope and ensure data integrity;
• Support deviation management, including investigation, resolution, and documentation of issues encountered during validation;
• Collaborate with cross-functional teams (QA, IT, Engineering, Manufacturing) to ensure seamless integration and validation of automation systems;
• Participate in internal and external audits and inspections, providing documentation and subject matter expertise as needed;
• Monitor and track validation lifecycle activities, ensuring timely execution and closure of validation deliverables;
• Implement and maintain change control procedures for validated systems to ensure continued compliance;
• Stay current with industry trends and regulatory updates, applying best practices to validation strategies and documentation.

• University degree, or equivalent qualification in Engineering or similar scientific field;
• Relevant experience in installation management or equipment qualification and automation preferably with a focus in chemical plants or Pharmaceutical industry;
• Training and experience of GMP and HSE practices;
• Relevant understanding and knowledge of legislation applicable to engineering projects and quality requirements applicable to technical installations;
• Competent (written and verbal) English;
• Computer literate with good working knowledge of the MS Office package;
• Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.

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.