The Company
The client is part of the global pharmaceutical company. The facility is focused on the development and manufacturing of biologic medicines, particularly in the fields of immunology, oncology, and infectious diseases. They specialize in producing large-scale biologic drugs, which are typically made from living cells and are used to treat complex diseases.
Role Description
The CQV Engineer provides quality oversight and technical expertise for engineering and validation activities within a regulated environment. This role supports the introduction of new systems and site-impacting changes by ensuring validation strategies are risk-based, compliant, and aligned with regulatory expectations and the Site Validation Master Plan. The position operates with a high degree of autonomy and contributes to continuous improvement across quality and engineering functions.
Responsibilities
- Providing quality oversight for CQV and engineering-related projects, ensuring compliance with regulatory and internal quality standards.
- Supporting new system introductions by acting as a technical subject matter expert throughout commissioning, qualification, and validation activities.
- Defining and applying risk-based validation strategies for site-impacting projects and changes in accordance with the Site Validation Master Plan.
- Reviewing and approving validation deliverables, including initial qualification, change-based validation, and periodic revalidation documentation.
- Developing and implementing strategies to support process changes and continuous improvement initiatives.
- Collaborating effectively across functions to support organizational quality objectives.
- Planning and prioritizing assigned work to meet departmental goals and project timelines.
- Ensuring ongoing compliance with applicable regulatory requirements, including GMP and GLP standards.
- Maintaining and enhancing quality systems and programs to ensure consistent product quality and regulatory compliance.
- Identifying deviations from established practices, performing impact assessments, and developing solutions for complex quality issues.
- Working closely with operating teams to support inspections, audits, statistical process control activities, and ongoing compliance monitoring.
- Supporting internal and external compliance audits as required.
Requirements
- Solid experience in CQV, validation, or quality engineering within a regulated manufacturing or laboratory environment.
- Strong knowledge of GMP, GLP, and applicable regulatory expectations.
- Demonstrated ability to develop and execute risk-based validation strategies.
- Proven experience reviewing and approving validation and qualification documentation.
- Ability to work independently on routine activities and adapt quickly to new or complex assignments.
- Strong analytical, problem-solving, and communication skills.
- Ability to collaborate effectively across engineering, quality, and operations teams.
Apply to our vacancy for more information. Looking forward to getting in touch!
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