QA Engineer (m/f/d)
EPM Scientific are currently partnered with a global pharmaceutical manufacturing organization operating within a GMP-regulated environment. They are currently seeking a QA Engineer to support engineering-related quality activities across manufacturing and laboratory sites. This role plays a key part in ensuring compliance of qualification, validation, and engineering systems in line with regulatory requirements.
The QA Engineer will be responsible for QA oversight of qualification and validation activities related to facilities, utilities, equipment, computerized systems, and cleaning processes. The role ensures full GMP compliance across manufacturing and laboratory environments, supporting both ongoing operations and project-based activities.
- Act as QA representative for engineering-related GMP activities on site, ensuring compliance across qualification and validation processes.
- Review and approve deviations, change controls, CAPAs, and validation variations, ensuring appropriate risk assessment and effectiveness checks.
- Support regulatory and client inspections, including preparation, participation, and response coordination for engineering-related topics.
- Oversee and continuously improve calibration and preventive maintenance programs for GMP-relevant equipment.
- Provide QA oversight during equipment qualification, requalification, and lifecycle management activities.
- Review and approve User Requirement Specifications (URS) and support definition of system requirements.
- Review and provide QA input on design documentation, including Functional Specifications and Configuration Specifications for systems.
- Approve qualification protocols, executed documentation, and validation reports in line with GMP expectations.
- Collaborate cross-functionally to drive continuous improvement initiatives within engineering quality processes.
Requirements:
- Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
- Minimum of 5 years of experience in the pharmaceutical or life sciences industry, including at least 3 years within a Quality function.
- Fluent in English; German language skills are preferred.
- Strong knowledge of GMP regulations and European regulatory requirements, with familiarity of German regulations considered an advantage.
- Experience in qualification/validation (IQ/OQ/PQ), computerized systems, and engineering processes in a GMP environment.
- Ability to work in a fast-paced, cross-functional environment with strong problem-solving skills.
- Detail-oriented with strong documentation skills and proficiency in Microsoft Office tools.
If this role is of interest to you, please apply directly to learn more. If not, feel free to share with your network.