The Company
Our client is a leading biopharmaceutical organization committed to ensuring product quality and patient safety through rigorous quality assurance processes. With a strong focus on compliance and continuous improvement, the company plays a key role in delivering high-quality pharmaceuticals worldwide.
Role Description
As a CQV Engineer, you will be responsible for supporting technical projects, developing commissioning, qualification, and validation (CQV) strategies, and driving the creation of system documentation. You will work independently under minimal supervision, ensuring that technical solutions meet internal customer requirements and align with company SOPs and quality standards.
Responsibilities
- Develop and update validation documents (Criticality Assessments, Validation/Commissioning/Qualification Plans, Risk Assessments, Test Protocols, Traceability Matrices, and Summary Reports)
- Lead Commissioning, Qualification, and Validation activities across assigned projects
- Provide technical guidance to ensure compliance with validation plans and SOPs
- Support project teams to deliver technical solutions aligned with regulatory and company standards
- Collaborate with cross-functional teams to drive project success
- Perform additional tasks or projects assigned by the supervisor.
- Bachelor’s degree in engineering, Life Sciences, or related field
- Minimum 3 years' experience in CQV execution within pharmaceutical manufacturing
- Hands-on experience with Secondary Packaging Systems and Print/Inspection Systems (e.g., Systech, Cognex)
- Strong background in Computerized Systems Validation
- Good understanding of GMP regulations and compliance environments
- Proficient technical writing skills in English
- Ability to work independently and manage multiple priorities
- Strong communication, problem-solving, and critical thinking skills
- Experience with project planning tools and reporting
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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.