Company
A leading biotech organization specializing in advanced cell therapies in oncology, known for its innovative and patient-focused approach. It operates with strong emphasis on quality, compliance, and GMP standards within a fast-paced, collaborative environment..
Role Description
As a Senior Quality Engineer, you are responsible for overseeing and supporting commissioning, qualification, and validation (CQV) activities, ensuring compliance with GMP, GLP, and regulatory standards while supporting engineering projects and new system implementations.
Responsibilities
- Provide quality oversight for CQV and engineering projects
- Support the introduction of new systems with technical expertise
- Develop and implement risk-based validation strategies
- Review and approve validation documents (initial, changes, revalidation)
- Handle deviations, investigations, and impact assessments
- Drive process improvements and support change management
- Ensure compliance with GMP, GLP, and regulatory requirements
- Collaborate with cross-functional teams and support audits
- Work closely with operations to maintain quality and process control
Requirements
- Proven experience in CQV within regulated industries (pharma/biotech)
- Strong knowledge of GMP, GLP, and regulatory compliance
- Experience with validation strategies and risk-based approaches
- Ability to analyze complex issues and provide effective solutions
- Good communication and stakeholder management skills
- Ability to work independently and in a team environment
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.