Senior Design 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.

The Mechanical Engineer SME is a recognized expert in mechanical systems and equipment within pharmaceutical manufacturing environments. This role is responsible for developing, maintaining, and ensuring adherence to Engineering Standards across the organization. The SME provides technical leadership, drives continuous improvement, and ensures compliance with regulatory and industry best practices, particularly in GMP environments.

Key Responsibilities

Engineering Standards Development & Governance

• Lead the creation, revision, and harmonization of mechanical engineering standards, specifications, and design guidelines.
• Ensure standards align with global regulatory requirements (e.g., FDA, EMA), industry best practices (e.g., ISPE, ASME, ISO), and internal quality systems.
• Collaborate with cross-functional teams (Quality, Validation, EHS, Operations) to ensure standards are practical and compliant.
• Maintain a central repository of engineering standards and ensure version control and accessibility.

Technical Expertise & Support

• Act as the go-to expert for mechanical systems including process and auxiliar equipment and piping, facilities design, HVAC, utilities production and distribution (Purified water, cooling and heating, nitrogen WFI, compressed air).
• Provide technical support for troubleshooting, root cause analysis, and CAPA development related to mechanical failures or deviations.
• Support design reviews, FAT/SAT, commissioning, and qualification of mechanical systems.

Compliance & Risk Management

• Ensure mechanical systems comply with GMP, safety, and environmental regulations.
• Participate in audits and inspections, providing expert input on mechanical engineering topics.
• Lead risk assessments (e.g., FMEA, HAZOP) for mechanical systems and propose mitigation strategies.

Continuous Improvement & Innovation

• Monitor industry trends and emerging technologies to enhance mechanical engineering practices.
• Drive initiatives to improve reliability, maintainability, and energy efficiency of mechanical systems.
• Promote standardization and modular design principles to reduce complexity and lifecycle costs.

Training & Knowledge Sharing

• Develop and deliver training programs on engineering standards and mechanical systems.
• Mentor junior engineers and contribute to talent development within the engineering function.
• Facilitate communities of practice and technical forums to share lessons learned and best practices.

• Master’s degree in mechanical engineering.
• Candidate will typically have at least 10 years of experience in mechanical engineering within pharmaceutical or regulated industries.
• Deep understanding of GMP, validation, and regulatory compliance.
• Proven experience in developing and implementing engineering standards.
• Strong analytical, problem-solving, and communication skills.
• Ability to work in a matrix organization and influence across functions and geographies
• Fluency in both written and spoken English.

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.