Process Engineer

hace 2 semanas

Barcelona, España Adryan A tiempo completo

Job Title: Process Engineer – Equipment & CQV Support (mAb Manufacturing)Consulte la descripción del puesto a continuación. Si confía en que tiene las habilidades y la experiencia adecuadas, envíe su solicitud hoy mismo. Location. Barcelona, Spain (on-site / hybrid) Engagement Type: Contract Duration: 10 months with possibility of extension Role Overview Adryan is seeking a Process Engineer to support a monoclonal antibody (mAb) program through the specification, procurement, installation, and qualification of manufacturing and quality control equipment. The role will work closely with manufacturing, QC, quality, engineering, and external vendors to ensure equipment is fit for purpose, compliant with GMP requirements, and ready for operational use. Key Responsibilities Equipment Specification & Procurement Support the definition of User Requirement Specifications (URS) for manufacturing and QC equipment used in mAb production. Provide technical input into vendor selection, technical evaluations, and purchase decisions. Review vendor documentation, FAT/SAT protocols, and technical design packages. Installation & Commissioning Oversight Act as on-site engineering support during equipment delivery, installation, and commissioning. Coordinate with vendors, facilities, automation, and validation teams to ensure timely execution. Identify and resolve technical issues arising during installation or start-up. Commissioning, Qualification & Validation (CQV) Support or lead IQ/OQ (and PQ where applicable) activities for manufacturing and QC equipment. Ensure qualification activities are aligned with GMP, internal standards, and regulatory expectations. Review and approve CQV documentation, protocols, and final reports. Cross-Functional Collaboration Interface with process development, manufacturing, QC, QA, and external suppliers. Support knowledge transfer to operations and quality teams for long-term equipment use. Required Qualifications & Experience Education Degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related technical discipline. Experience Experience supporting mAb or biologics manufacturing environments . Hands-on experience with equipment specification, installation, and CQV in a GMP-regulated setting. Familiarity with manufacturing and/or QC equipment typically used in biologics facilities (e.g., bioreactors, chromatography systems, filtration, analytical/QC instruments). Experience working with vendors and managing on-site activities during installation and qualification phases. Skills & Competencies Strong understanding of GMP and GxP requirements. Practical, solution-oriented engineering mindset. Ability to work independently while coordinating with cross-functional teams. Clear and effective communication skills. Comfortable operating in a project-based, fast-paced environment. Language & Location Fluency in English required; Spanish strongly preferred. Ability to work on-site in Barcelona during key project phases. Why This Role Direct involvement in a high-visibility mAb manufacturing project. Hands-on ownership from equipment selection through qualification. xcskxlj Opportunity to act as the local technical interface between client teams and vendors.

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