MF02-050625 Qualification Scientist - QA Lab - Automation and CQV Projects

Veg Group; Barcelona; Presencial; EUR 45.000 - 75.000; Jornada completa

Descripción de la vacante

An established industry player is looking for a skilled Qualification Scientist for their QA Lab, focusing on Automation and CQV projects. This role demands a strong background in ensuring compliance with Good Manufacturing Practices (GMP) while managing projects efficiently. The ideal candidate will have extensive experience with laboratory automation systems and regulatory requirements, making a significant impact in the Pharmaceutical and Biotechnology sectors. Join a dynamic team where your expertise will contribute to delivering high-quality solutions in a fast-paced environment.

Formación

• 5+ years of project management in GMP-regulated labs.
• Experience with laboratory automation and CQV processes.

Responsabilidades

• Qualify equipment within a QA Laboratory.
• Ensure compliance with Good Manufacturing Practices (GMP).

Conocimientos

CQV Processes

Good Manufacturing Practices (GMP)

Project Management

Regulatory Compliance (FDA, EMA, ICH)

Technical Writing

Educación

Bachelor’s degree in Engineering

Bachelor’s degree in Life Sciences

Herramientas

MS Windows

Microsoft Office

Laboratory Automation Systems

Descripción del empleo

Career Opportunities with Validation & Engineering Group

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Current job opportunities are posted here as they become available.

MF02-050625 Qualification Scientist - QA Lab - Automation and CQV Projects

Validation & Engineering Group, Inc. (V&EG) is a leading service provider offering solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in areas such as Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and more.

We are seeking an experienced Commissioning, Qualification, and Validation (CQV) Scientist to qualify equipment within a Quality Assurance (QA) Laboratory. The ideal candidate will have a strong background in CQV, ensuring compliance with Good Manufacturing Practices (GMP), and capable of delivering projects on time and within budget.

• Qualification Scientist - QA Lab - Automation and CQV Projects

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• At least 5 years of project management experience in a GMP-regulated laboratory environment.
• Proven experience with laboratory automation systems and CQV processes.
• Strong knowledge of regulatory requirements, including FDA, EMA, and ICH guidelines.
• Proficiency in MS Windows and Microsoft Office applications.
• Experience in developing and executing Design Documentation (URS, DS), IQ, OQ, PQ protocols, deviations, and reports.
• Knowledge of SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT), and Site Acceptance Test (SAT).
• Technical writing skills and experience with investigation processes.
• Availability to work extended hours, including weekends and holidays if necessary.