Lead Engineer CQV (m/f/d)

Exyte; Nürnberg; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A global leader in engineering is seeking a Lead Engineer CQV to manage CQV activities in the life sciences sector. This position involves leading a team, ensuring compliance with GMP and regulatory standards, and liaising with various stakeholders. Candidates must have a relevant degree and several years of experience in CQV. The role is based in Nuremberg, offering mobile working options and various perks including fitness subsidies.

Leistungen

Free specialty coffees

Fitness membership subsidies

Mobile working options

Buddy system for onboarding

Onboarding events

Qualifikationen

• Several years of experience in CQV within the life sciences industry.
• Ability to lead teams and manage complex projects.
• Strong knowledge of ISO, 21 CFR, Annex 15, and data integrity.

Aufgaben

• Lead and mentor CQV engineers.
• Define CQV strategies and ensure compliance.
• Supervise commissioning and validation activities.

Kenntnisse

Leadership

GMP knowledge

Project Management

Fluent German

Good English

Ausbildung

Degree in Biotechnology

Degree in Pharmaceutical Engineering

Degree in Process Engineering

Jobbeschreibung

Description

Discover your exciting role

Exyte is a global leader in design, engineering and delivery of facilities for high-tech industries serving people and planet by energy saving & more sustainable engineering.
As Lead Engineer CQV (m/f/d), you will take a key leadership role in the Bio Life Sciences sector at Exyte Central Europe. You will lead CQV activities for complex pharma and biotech projects, ensuring compliance with GMP and regulatory standards. You will manage a team of engineers, coordinate stakeholders, and drive project success from planning to execution.
Your base will be our regional office in Nuremberg, with regular on-site presence at client facilities.

Explore your tasks and responsibilities

• Lead and mentor CQV engineers, ensuring efficient resource allocation and professional development.
• Define CQV strategies and ensure alignment with project objectives, timelines, and compliance requirements.
• Supervise commissioning, qualification, and validation activities for HVAC, cleanroom, and clean media systems according to GMP regulations.
• Approve CQV documentation (specifications, risk analyses, protocols, reports) and ensure regulatory compliance.
• Act as primary interface between CQV team, clients, technical engineering, automation, QA, and suppliers.
• Oversee FAT/SAT activities and review supplier documentation.
• Implement best practices and drive process optimization across projects.

Show your expertise

• Degree in Biotechnology, Pharmaceutical, Building Services Engineering or Process Engineering or related field.
• Several years of experience in CQV within life sciences industry, including leadership responsibilities.
• Strong knowledge of GMP, ISO, 21 CFR, Annex 15, data integrity
• Proven ability to lead teams and manage complex projects.
• Fluent German and good English skills required.
• High level of quality awareness, efficiency, and accuracy.

What we offer

• Your Start at Exyte:Join a two-day onboarding event with new colleagues.
• Attractive Location: Our site offers spacious workspaces with height-adjustable desks.
• Buddy System: Several weeks of onboarding with your teammates.
• Work-Life Balance: You can switch to mobile working at any time.
• Catering: Free specialty coffees and water dispensers are available on every floor.
• Stay Fit: Exyte subsidizes your fitness membership via Qualitrain at over 5,000 locations across Germany.

Contact:

You want to be part of the Exyte team? We look forward to receiving your application!
For further questions and information, please do not hesitate to contact Snezana Dragojevic via E-Mail at [e-mail]

Please note that we only consider applications submitted through our application portal. Applications sent via email will not be considered due to data protection regulations.