Qualification & Validation Engineer (80–100%)

Atp Group; Indiana (PA); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Attractive remuneration packages

Professional development and continuous training

Excellent social security coverage

Job summary

A Life Science compliance firm is looking for a Qualification & Validation Engineer to support clients in complex GMP-regulated projects. You'll plan, coordinate, and execute qualification activities for laboratory equipment and cleanrooms. The ideal candidate has a university degree in Engineering or Sciences, at least 5 years of experience in the pharmaceutical industry, and strong knowledge of GMP regulations. The role offers attractive remuneration and professional development opportunities.

Qualifications

• Minimum 5 years of relevant experience in qualification & validation.
• Fluent in English and German and/or French.
• Experience in facility projects and/or digital quality systems is advantageous.

Responsibilities

• Plan and execute commissioning, qualification, and validation activities.
• Oversee on-site qualification and validation testing.
• Manage small project teams ensuring quality standards.

Skills

GMP regulations knowledge

Analytical mindset

Customer-oriented communication

Project management

Education

University degree in Engineering or Sciences

Tools

MS Office

MS Project

LIMS

TrackWise

SAP

Job description

Job Brief

ATP-CGPharm has been supporting clients in the Life Science Industry for more than 30 years, delivering expertise in facility and process engineering, commissioning, qualification & validation, quality assurance and quality control consulting, environmental monitoring, and GxP Digital Solutions.

We contribute every day to ensuring pharmaceutical product quality, patient safety, and full regulatory compliance by supporting the continuous improvement of our clients's manufacturing processes and quality systems. Today, we are proud to be recognized across the Life Science Industry as a preferred business partner and employer of choice.

To support our continued growth, we are looking for motivated professionals and experienced experts.

Your Role

As a Qualification & Validation Engineer, you will support our clients in complex GMP-regulated projects within pharmaceutical, biotechnology, and medical device environments.

Your responsibilities include:

• Planning, coordinating, and executing commissioning, qualification and validation (CQV) activities for:

  • Process and laboratory equipment
  • Cleanrooms and HVAC systems
  • GMP utilities (PW, WFI, clean steam, compressed gases, etc.)
  • Cleaning validation
  • Computerized Systems Validation (CSV)
  • Supporting facility and process engineering projects from Design Qualification (DQ) through operational readiness
  • Authoring and reviewing GMP lifecycle documentation such as:
    • Risk Assessments (FMEA, HACCP)
    • URS, FS/DS, DQ
    • FAT and SAT documentation
    • IQ, OQ and PQ protocols and reports
    • Validation Master Plans
• Performing and overseeing on-site qualification and validation testing
• Supporting deviation investigations, CAPAs, and change control processes
• Applying risk-based validation strategies in line with current regulatory expectations (EU GMP, FDA, Annex 1, GAMP 5, data integrity guidelines)
• Managing work packages or small project teams, ensuring compliance with timelines, budgets, and quality standards
• Contributing to digital validation initiatives and GxP Digital Solutions where applicable

About You

• University degree in Engineering, Pharmaceutical Sciences, Biotechnology, Chemistry, or a related technical/scientific discipline
• Minimum 5 years of relevant experience in qualification & validation within the pharmaceutical, biotech, or medical device industry
• Strong knowledge of GMP regulations (EU GMP, FDA)
• Experience in facility projects and/or digital quality systems is an advantage
• Strong analytical mindset and structured working approach
• Customer-oriented with excellent communication skills
• Mobile and flexible regarding project assignments within Switzerland
• Fluent in English and German and/or French (spoken and written)
• Confident use of MS Office; familiarity with MS Project, LIMS, TrackWise, SAP, or electronic document management systems is beneficial

Our Offer

ATP-CGPharm offers long-term career opportunities within a stable and growing organization operating at the forefront of Life Science engineering and compliance.

In addition to an inspiring and collaborative work environment, we offer:

• Attractive remuneration packages
• Excellent social security coverage
• Professional development and continuous training
• Diverse and challenging projects with leading Life Science companies
• A culture that values expertise, commitment, and personal growth

Start Date: Immediately

Additional Requirements:

• No visa sponsorship required
• Must be authorized to work in Switzerland