Process Engineer – Equipment & CQV Support
hace 4 horas
Barcelona
Job Title: Process Engineer – Equipment & CQV Support (mAb Manufacturing) Location. Barcelona, Spain (on-site / hybrid) Engagement Type: Contract Duration: 10 months with possibility of extension Asegúrese de leer detenidamente la información sobre esta oportunidad antes de presentar su candidatura. 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., • Act as on-site engineering support during equipment delivery, installation, and commissioning., • Coordinate with vendors, facilities, automation, and validation teams to ensure timely execution., • 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., • 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 • 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)., • 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., • Fluency in English required; Spanish strongly preferred., • 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.