Ambit Iberia fournit des services technologiques et de conseil aux entreprises, notamment dans les sciences de la vie.
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 …
Repères sur Ambit Iberia
- Domaine officiel
- ambit-iberia.com
- Offres ouvertes
- 13
Détails de l’offre
La description complète publiée par Ambit Iberia.
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. If you are passionate about process engineering and project management in regulated manufacturing environments, we would love to hear from you. Apply now and become part of an exciting long-term project. Our goal is that you are well in every way!
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