Senior CQV Engineer
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We are urgently seeking senior-level CQV Subject Matter Experts (SMEs) to assist in developing User Requirement Specifications (URS) and conducting risk assessments for process-equipment projects. The ideal candidates will bring extensive experience in CQV activities, particularly in brownfield settings, and will have a hands‑on understanding of complex process equipment.
Key Responsibilities
- Lead and support the development of User Requirement Specifications (URS) for process equipment.
- Facilitate and participate in risk assessments ensuring comprehensive analysis and mitigation planning.
- Provide technical expertise and guidance to project teams throughout CQV activities.
- Collaborate closely with stakeholders, including engineering, quality, and operations teams.
Qualifications
- Minimum of 10 years of direct CQV experience on process-equipment projects, preferably in brownfield environments.
- Deep knowledge of reactors, centrifuges, filters/filter dryers, dryers, storage tanks, and containment solutions is a strong advantage.
- Senior professionals with biopharma backgrounds and proven experience in CQV execution and complex process equipment are highly valued.
- Familiarity with digital CQV platforms, specifically Kneat, is a significant plus.
- Excellent communication skills and ability to work collaboratively in multidisciplinary teams.
Preferred Skills
- Hands‑on experience with process equipment in pharmaceutical or biopharma environments.
- Demonstrated expertise with containment solutions and advanced CQV methodologies.
- Proven track record of success in senior-level CQV project roles.
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