Senior Design Engineer

Senior Design Engineer

Hovione

Lisbon, Portugal

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.

We are looking to recruit a Candidate

• 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.