CQV Lead/Experts (BioPharma)

Location: Onsite in Frankfurt, Germany

Company

hirify.global is an employee-owned international project delivery firm serving the pharmaceutical, food, medtech, and mission-critical sectors.

What you will do

• Deliver commissioning, qualification, and validation scope across design, construction, CQV, and start-up.
• Lead CQV strategy and execution as a cross-functional workstream lead.
• Coordinate system boundaries, risk assessments, CQV plans, and regulatory alignment.
• Develop and execute FAT, SAT, IQ, OQ, and PQ documentation.
• Integrate engineering, automation, operations, manufacturing, quality, and vendor activities.
• Drive start-up readiness, performance verification, data integrity, documentation quality, and inspection readiness.

Requirements

• Degree in pharmaceutical science, electrical, mechanical, or process engineering, or a related discipline.
• 8+ years of commissioning and qualification experience across multiple BioPharma, chemical API, or aseptic processing projects.
• Project execution or construction experience in Germany.
• Expertise in GMP compliance and German and European regulatory requirements.
• Strong organization, adaptability, and ability to deliver quality work within project deadlines, budgets, client standards, and health and safety procedures.
• Fluent German and English required.

Culture & Benefits

• Employee-owned organization with an inclusive and collaborative culture.
• Commitment to mutual respect, belonging, inclusion, and diversity.
• Focus on corporate responsibility and sustainability.
• Reasonable accommodations are available during the hiring process for candidates with disabilities.