Qualification Engineer (m/f/d) Pharmaceutical Plants

Would you like to support challenging projects in the pharmaceutical industry and ensure that production facilities meet regulatory requirements? Then become part of our Industrial Solutions team at the Frankenthal (Pfalz) location and support our customers in the qualification of pharmaceutical plants and systems.

Tasks

• Planning, execution, and documentation of qualification measures for pharmaceutical plants and technical systems in accordance with GMP requirements
• Creation and maintenance of qualification documents such as risk analyses, URS, DQ, IQ, OQ, and PQ plans, as well as the associated reports
• Preparation, coordination, and execution of Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT)
• Support of commissioning and ensuring GMP-compliant plant release
• Processing and follow-up of deviations, CAPA measures, and changes in the qualification process
• Taking responsibility in sub-projects or independently leading qualification projects

Qualification

• Successfully completed degree in Pharmaceutical Technology, Process Engineering, Medical Technology, Mechanical Engineering, Electrical Engineering, or a comparable qualification
• Several years of professional experience in qualification and validation in a GMP-regulated environment
• In-depth knowledge of plant qualification (DQ, IQ, OQ, PQ) and experience with risk analyses
• Experience with pharmaceutical production plants, laboratory plants, or utility systems is an advantage
• Proficient in GMP requirements and relevant regulatory guidelines
• Structured and independent way of working, as well as a high level of quality awareness
• Very good German skills (minimum C1 level) and good English skills (minimum B2)

Benefits

Permanent employment with security: We have been around since 1994!

Flexible working hours: You can organize your working hours freely within the framework of flexible working hours.

Hybrid working: We offer you a modernly equipped workplace and additionally give you the opportunity for mobile working.

Start with an onboarding program: You will be accompanied by a mentor so that you can quickly feel comfortable and find your way around.

Family-friendly company: We support you and your family, e.g., with a kindergarten subsidy and 5 days of sick leave for children with 100% wage compensation.

Attractive remuneration models: You will receive an annual salary, enjoy additional vacation days, and paid special leave for certain occasions. Overtime will be compensated by time off in lieu, or with a surcharge of 25%.

Individual coaching: Standing still is regressing. Therefore, we give you the opportunity to develop further. We organize training tailored to you.

Company events: At regular intervals, we organize leisure events for you and your colleagues, where fun and enjoyment of working together are the focus.

Bike leasing offers: We offer you the opportunity to lease bicycles at attractive conditions. The bikes are available for both private and business use.

Employee benefits and company social benefits: You will enjoy many corporate benefits, e.g., a company pension plan with employer contribution, accident insurance that is also valid privately, changing offers of courses in cooperation with Techniker Krankenkasse, discounts at the Fitnessstudio Pfitzer Gruppe and company headquarters with employee parking. Our company headquarters is conveniently located and easily accessible by car or public transport.

Why you should start at EXCO

EXCO is a owner-managed technical service provider for development and quality assurance with a now 30-year success and growth story. With over 150 employees at 8 locations, we realize innovative projects for our globally active customers from the medical technology, pharmaceutical, biotechnology, and chemical industries. We offer our employees long-term career prospects and the opportunity to grow with us in a crisis-proof industry.

Further information about EXCO as an employer and your entry and development opportunities can be found on our career page.

We look forward to getting to know you!

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