Documentation & Validation Engineer

GEA Group; Halle (Saale); Vor Ort; EUR 45.000 - 80.000; Vollzeit

Zusammenfassung

An established industry player is seeking a talented Documentation & Validation Engineer to join their dynamic team in Halle. This role involves ensuring compliance with GMP guidelines for automated control systems, writing tests based on user requirements, and performing risk assessments. The ideal candidate will have a technical degree and relevant experience in a pharmaceutical environment. With a commitment to fostering a supportive and collaborative atmosphere, this company offers excellent working conditions and opportunities for professional growth. If you are passionate about validation engineering and thrive in a motivated team, this is the perfect opportunity for you.

Leistungen

Company car

Good primary and secondary working conditions

Pleasant working atmosphere

GSM

Qualifikationen

• At least 2 years of experience in a pharmaceutical GMP environment.
• Knowledge of GAMP5 and computer system validation.

Aufgaben

• Responsible for validation according to GMP guidelines for automated control systems.
• Writing commissioning and qualification tests based on user requirements.

Kenntnisse

GMP guidelines

Risk assessments

Analytical skills

Communication skills

Fluent in English

Knowledge of French and Dutch

Ausbildung

Bachelor or Master in Technical Degree

Tools

Word

Excel

Outlook

PLC

SCADA

GAMP5

21CFR part 11

Jobbeschreibung

For the Documentation & Validation Engineering team at Gea Process Engineering in Halle, we are looking for a Documentation & Validation Engineering.

Responsibilities / Tasks

• Responsible for the validation according to the current GMP guidelines for an automated control system.

• Writing commissioning and qualification tests based on user requirements and functional specifications.

• Executing tests in an accurate and GMP manner.

• Performing risk assessments § Point of contact for validation topics, both internal and external.

• Work in a project team, follow up on schedules and milestones.

Your Profile / Qualifications

• Bachelor or master in technical degree.

• At least 2 years relevant (pharmaceutical GMP environment) experience.

• Knowledge of office applications: Word, Excel, Outlook.

• Experience with GAMP5, 21CFR part 11 and computer system validation.

• Affinity with computerized systems, such as PLC, SCADA.

• Fluent in English and good knowledge of French and Dutch.

• Good analytical & communication skills.

• Willingness to travel (sporadically).

Our offer:

• A responsible and varied job in a motivated and successful team.

• Good primary and secondary working conditions.

• A pleasant and collegial working atmosphere.

• GSM.

• Company car.

What happens once your application is submitted?

You will receive an email when your application has been processed.

One of our Talent Acquisition partners will review and verify if your application meets the qualifications of the role.

If your application has been successfully verified, you will be invited to a first interview either virtually or face-to-face.

Usually after the second/third interview round we will make a decision.
Please do not hesitate to reach out to our team at any stage of your application.

Did we spark your interest?
Then please click apply above to access our guided application process.