Spezialist in der Qualifizierung und Softwarevalidierung (Mensch)

Responsibilities

We are representing a confidential pharmaceutical organization seeking a specialist in qualification and software validation. In this role, you will ensure that production equipment—including filling lines, clean utilities systems, and autoclaves—meets GMP requirements throughout their lifecycle.

Your core responsibilities include:

• Planning, executing, and documenting qualifications and requalifications of existing pharmaceutical production systems
• Creating and maintaining recurring assessments, annual requalification protocols, and audit trail reviews
• Developing User Requirement Specifications (URS) and conducting risk analyses in accordance with GMP guidelines
• Writing and updating Standard Operating Procedures (SOPs) for equipment operation and cleaning processes
• Supporting audits, preparing deviation reports, managing change control requests, and implementing CAPAs
• Driving continuous improvement in GMP compliance and assisting with regulatory authority inspections

What We're Looking For

Our ideal candidate brings a strong technical foundation combined with pharmaceutical compliance expertise:

• Completed degree in pharmaceutical engineering or chemical engineering, or technical vocational training with relevant advanced certification (e.g., pharmaceutical operator or chemical technician with further qualification)
• Proven experience in pharmaceutical production with solid knowledge of GMP compliance and qualification systems
• Hands-on experience in computer software validation
• Expertise in audit trail reviews, URS development, and risk analysis methodologies such as FMEA
• Proficient in MS Office with very good German and good English language skills
• Self-motivated with a structured work approach and strong sense of responsibility
• Technical understanding paired with a pragmatic, solution-oriented mindset
• Communicative, team-oriented personality who thrives under pressure

How We Work With You

Candidates apply directly through Get A Job.ai. Our talent team will conduct an initial screening to understand your background and career goals. We then present qualified candidates to our client for consideration. Please do not contact the employer directly—all communication flows through our recruitment process to ensure a professional experience for everyone involved.

This position offers excellent work-life balance with partial remote work options, flat hierarchies with significant autonomy, comprehensive professional development opportunities, and additional benefits including company pension scheme and supplementary health insurance.

Pay

Compensation details will be discussed during the screening process based on your qualifications and experience.

Equal Employment Opportunity: Get A Job.ai is committed to inclusive hiring practices and considers all qualified applicants regardless of background.