Project Engineer (Process) Compounding - On-Site

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 (flexible schedule)

• On-site position

Conditions 🌱

• Competitive salary package based on experience and qualifications.

• Meal voucher provided for office working days.

• Flexible compensation plan (free of income tax) where we provide you with medical insurance, public transport ticket and childcare check.

• Access to discounted gym memberships through partner networks.

• Extensive training and professional development catalogue.

At Ambit Iberia, we are committed to equal opportunities and workplace diversity. Applications from candidates with a certified disability of 33% or higher will be given due consideration, in accordance with applicable legislation. 

Our goal is that you are well in every way!