The Company
A global pharmaceutical organization focused on developing, producing and commercializing vaccines and antibody-based solutions to fight infectious diseases. The site operates in a highly innovative, fast-paced environment with strong emphasis on technical excellence, compliance and continuous improvement.
About the Role
This role supports quality, GMP compliance and process excellence within the engineering, validation and maintenance organization. The Senior Quality Engineer drives continuous improvement, ensures compliant qualification and maintenance activities, leads process excellence initiatives, supports investigations and CAPA management, and acts as the quality representative for all EVM sub-groups.
Responsibilities
- Lead continuous improvement initiatives across engineering, maintenance and validation
- Serve as subject matter expert for validation activities
- Support all EVM sub-groups to optimize processes and communication flows
- Apply methodologies such as six sigma and greenbelt tools for process excellence
- Maintain performance measurement systems, metrics and KPIs
- Safeguard compliance of engineering and maintenance activities within GMP boundaries
- Support CAPA, deviations, events and quality investigations
- Conduct internal audits and follow-up actions
- Align closely with business partners and stakeholders across departments
- Advise on process excellence in maintenance and project execution
Requirements
- Bachelor degree in mechanical engineering, electrical engineering, installation techniques or process engineering
- Experience in process excellence
- Yellow belt or greenbelt certification preferred
- Strong knowledge of GMP, validation and qualification principles
- Familiarity with relevant guidelines such as FDA, GMP, ICH, ASTM, ISPE
- Experience in pharmaceutical, biotechnology or process industry environments preferred
- Minimum 4–8 years experience as a quality engineer or strong GMP exposure in a similar setting
- Strong communication, analytical skills and stakeholder management
- Ability to work independently, handle changing priorities and manage workload under pressure
Other Information
If you are interested and want to apply, please submit your application via the apply button below and contact me.
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About us
Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.
SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.
Our team of knowledgeable professionals provides customized staffing services to clients and candidates, including secondment, direct hire, temporary-to-hire, temporary staffing, brokering, Statement of Work and we approach each type with the same degree of professional assessment. Our refined and collaborative style is unmatched in the staffing industry. We’re able to see beyond the surface to create matches that result in successful careers for our candidates and valuable talent for our clients.
Effective employment solutions need to put the right person in the relevant place every time, using advanced systems to streamline costs and time-frames for clients.