About the Role

We are looking for a Project Engineer (Process) Compounding to lead engineering projects related to manufacturing and compounding processes within a highly regulated environment. The successful candidate will be responsible for managing process equipment and auxiliary systems projects from the design specification phase through commissioning and start-up, ensuring compliance with quality standards, safety regulations, and operational efficiency requirements.

This is a key position focused on delivering projects on time, within budget, and according to technical specifications, while collaborating with multidisciplinary internal teams and external suppliers.

Key Responsibilities

- Manage process equipment and auxiliary systems engineering projects from design specification through commissioning and start-up.

- Independently define technical requirements for equipment and installations.

- Coordinate and monitor activities, milestones, and deliverables from internal teams and external suppliers.

- Ensure compliance with GMP regulations, EU GMP Annex 1 requirements, and machinery safety directives.

- Lead and coordinate:

- FAT (Factory Acceptance Tests)

- SAT (Site Acceptance Tests)

- Equipment installation and commissioning activities

- Equipment start-up and operational handover

- Provide support during equipment qualification and validation phases.

- Oversee project planning, budget control, and overall project financial management.

- Identify technical risks and implement corrective actions to ensure successful project execution.





- Drive initiatives focused on improving production efficiency, equipment reliability, and process performance.

Requirements

Must-Have

- Minimum of 2 years of experience as a Project Engineer , Process Engineer , or in a similar role.

- Proven experience within Compounding, Manufacturing, or Production environments.

- Solid knowledge and application of GMP standards and regulated industry requirements.

- Experience managing suppliers and industrial engineering projects.

- Ability to work autonomously while leading complex technical projects.

- Hands‑on experience with FAT, SAT, commissioning, and equipment start‑up activities .

- English proficiency B2 level (written and spoken).

Nice-to-Have

- Knowledge of EU GMP Annex 1 requirements.

- Experience within the pharmaceutical, biotechnology, or related industries .

- Familiarity with equipment qualification and validation processes.

- Experience in continuous improvement initiatives and process optimization.

- Additional technical certifications relevant to project or process engineering.

What We Offer

- Opportunity to join a strategic long‑term project.

- Dynamic and highly technological working environment.

- The chance to lead impactful engineering projects with direct operational visibility.

- Professional growth within a multidisciplinary and collaborative team.

Schedule

- 08:00 - 17:00, Monday to Friday (versátil schedule)

- On‑site position

Conditions

- Competitive salary package based on experience and qualifications.

- Meal voucher provided for office working days

📌 Project Engineer (Sant Cugat del Vallès)
🏢 Ambit Iberia
📍 Sant Cugat del Vallès