CQV Lead (BioPharma)

TL;DR

CQV Lead (BioPharma): Delivering commissioning, qualification, and validation services across the full project lifecycle for large-scale BioPharma projects with an accent on GMP compliance, regulatory requirements, and system integration. Focus on developing CQV strategies, executing validation documentation (FAT, SAT, IQ/OQ/PQ), and ensuring ALCOA+ data integrity.

Location: Onsite in Frankfurt, Germany

Company

hirify.global is an employee-owned international project delivery firm specializing in the pharma, food, and medtech sectors.

What you will do

• Lead CQV strategy and execution across the full project lifecycle, including Design, Construction, CQV, and Start-up.
• Develop and execute critical CQV documentation such as FAT, SAT, IQ, OQ, and PQ.
• Ensure strict compliance with GMP standards and European regulatory requirements.
• Coordinate system boundary definitions, conduct risk assessments, and define CQV plans.
• Interface with engineering, automation, and operations teams to ensure seamless system integration.
• Drive system start-up readiness and ensure ALCOA+ data integrity principles are applied.

Requirements

• Degree in Pharmaceutical Science, Electrical or Mechanical Engineering, Process Engineering, or a related discipline.
• 8+ years of experience in commissioning and qualification within BioPharma, Chemical APIs, or Aseptic Processing environments.
• Proven project execution and construction experience in Germany.
• Expertise in GMP compliance and German/European regulatory requirements.
• Fluent in both German and English.

Culture & Benefits

• Employee-owned company structure ensuring a committed and driven work environment.
• Strong corporate focus on Responsibility and Sustainability (2025 business strategy).
• Inclusive culture valuing diversity, mutual respect, and belonging.
• Fair and accessible hiring process with reasonable accommodations for candidates with disabilities.