обновлено 14 дней назад
CQV Manager (Pharma)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
CQV Manager (Pharma): Leading commissioning, qualification, and validation activities across the full project lifecycle in biopharmaceutical, chemical API, and aseptic processing environments with an accent on GMP compliance, CQV strategy, and inspection-ready documentation. Focus on defining system boundaries, executing FAT/SAT and IQ/OQ/PQ protocols, integrating engineering and operations teams, and verifying start-up performance.
Location: Onsite in Basel, Switzerland
Company
is an employee-owned international project delivery firm serving the pharmaceutical, food, medtech, and mission-critical sectors.
What you will do
- Lead commissioning, qualification, and validation activities across design, construction, CQV, and start-up phases.
- Develop and execute CQV strategies, plans, risk assessments, and system boundary definitions.
- Prepare and execute FAT, SAT, IQ, OQ, and PQ documentation.
- Coordinate engineering, automation, quality, manufacturing, operations, and vendor interfaces.
- Drive start-up readiness, performance verification, inspection readiness, and ALCOA+ data integrity.
- Define critical process parameters and critical quality attributes in line with regulatory guidance.
Requirements
- Degree in pharmaceutical science, electrical or mechanical engineering, process engineering, or a related discipline.
- At least 8 years of commissioning and qualification experience across multiple projects in biopharma, chemical API, or aseptic processing environments.
- Project execution or construction experience in Switzerland.
- Expertise in GMP compliance and Swiss regulations.
- Fluent German and English.
- Strong organization, adaptability, and ability to deliver quality work within deadlines, budgets, client standards, and health and safety requirements.
Culture & Benefits
- Employee-owned company with an inclusive and collaborative culture.
- Work across international projects in pharmaceutical, food, medtech, and mission-critical sectors.
- Commitment to inclusion, diversity, sustainability, and corporate responsibility.
- Reasonable accommodations are available during the hiring process for candidates with disabilities.
Hiring process
- Accessible and fair recruitment process with accommodations available upon request.
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