The Company
Our client is a global biotech leader focused on developing innovative treatments for serious illnesses. With decades of groundbreaking research, they are recognized for their commitment to improving patient care through advanced medical solutions.
Role Description
As a CQV Engineer (GMP), you will support technical projects with minimal supervision, reporting to the Validation & Compliance Manager. You will perform hands-on commissioning and qualification tasks, ensuring compliance with internal standards and procedures.
Key Responsibilities:
Documentation:
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Develop and update various validation documents, such as:
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System Level Criticality Assessments
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Validation, Commissioning, and Qualification plans
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Risk assessments
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Test protocols
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Requirement traceability matrices
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Commissioning, Qualification, and Validation summary reports
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Testing:
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Lead and participate in commissioning, qualification, and validation activities.
Technical Support:
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Provide guidance to project teams to ensure technical solutions align with validation plans and internal requirements.
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Ensure adherence to relevant standard operating procedures (SOPs).
Requirements
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Bachelor’s degree in Engineering or a related field.
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3+ years of experience in commissioning, qualification, and validation within manufacturing or related industries.
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Experience with computerized systems validation.
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Hands-on experience with commissioning and qualification activities.
- Good understanding of the validation process and documentation.
- Familiarity with GMP compliance
Other Information
If you are passionate about working in a collaborative environment and contributing to technical projects, apply to this vacancy now!
Look forward to chatting with you!
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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.