The Company
Our client is an innovative biotechnology organization operating in a highly regulated GMP environment, focused on developing advanced cancer immunotherapy solutions.
Job Description
We are looking for a highly skilled Senior Quality Engineer to join our client’s team. The role focuses on overseeing quality aspects related to the commissioning, qualification, and validation of new systems and processes, ensuring compliance with industry standards and regulatory requirements.
Responsibilities
- Provide expert quality oversight for Commissioning, Qualification, and Validation (CQV) projects.
- Support the introduction of new systems by acting as a technical resource and offering expert guidance.
- Develop risk-based validation strategies for site-impacting projects, ensuring adherence to the Site Validation Master Plan.
- Review and approve all validation documentation, including initial, change-based, and periodic revalidation reports.
- Create strategies for implementing process changes and ensure their compliance with quality standards.
- Collaborate with cross-functional teams to improve organizational processes and ensure smooth project execution.
- Prioritize tasks effectively to meet departmental goals, working with minimal supervision.
- Ensure ongoing compliance with regulatory requirements, including GMP and GLP standards.
- Identify and troubleshoot complex issues, assess deviations, and evaluate the impact on quality and compliance.
- Work closely with operating teams to conduct inspections, audits, and statistical process control activities.
- Support compliance audits and contribute to continuous improvement initiatives as needed.
Requirements
- Significant experience in quality assurance within regulated environments, preferably in life sciences or manufacturing.
- Strong knowledge of validation principles, CQV processes, and regulatory standards (GMP, GLP).
- Ability to develop strategies for process validation and change control.
- Excellent problem-solving and analytical skills.
- Proven ability to work independently and manage multiple priorities.
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.