Senior Compliance & CQV 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.

As a CQV (Commissioning, Qualification, and Validation) Senior Engineer at Hovione, you lead complex engineering initiatives across pharmaceutical and chemical manufacturing environments. The role bridges technical excellence, regulatory compliance, and cross-functional collaboration to ensure robust, GMP-compliant systems and equipment.

Role Overview

You are specialized in the design, implementation, and qualification of manufacturing systems, utility infrastructures, and automation technologies. Your work ensures that engineering solutions consistently meet high standards for quality, safety, and productivity, while fully complying with global regulatory frameworks such as cGMP and FDA guidelines. 

Key Responsibilities

Body of Knowledge & Standards

• Develop and maintain CQV standards, SOPs, and technical guidelines.
• Provide expert feedback on project compliance and mentor engineers on best practices.
• Support readiness for regulatory inspections and internal audits.

Engineering Projects

• Lead CQV scope across project phases: design, commissioning, qualification.
• Define and execute CQV plans, manage resources, and mitigate risks.
• Coordinate cross-functional teams and ensure seamless project delivery.

Technical Services

• Resolve complex equipment/system challenges with a focus on compliance and performance.
• Author and review technical documentation (IQ/OQ protocols, test reports, SOPs).
• Conduct root cause analysis and implement CAPAs for system deviations.
• Deliver training and support documentation for operations and maintenance teams.

Scope & Impact

• Manage vendor scopes and contribute to project budget estimations.
• Ensure lifecycle compliance and mentor junior staff in change management and deviation resolution.

Qualifications & Expertise

• Education: University degree in Engineering (Chemical, Mechanical, Electrical, Automation) or related scientific field.
• Experience: 5+ years in CQV, with strong exposure to system design, implementation, and qualification in pharma/chemical industries.
• Technical Skills:
  • Deep understanding of GMP, GAMP, and engineering compliance.
  • Proficient in MS Office, CAD tools, and digital design platforms.
  • Fluent in English (written and spoken).

Core Competencies

• Advanced problem-solving and analytical thinking.
• Independent contributor with leadership in project teams.
• Strong communication and mentoring capabilities.

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.