Job detail for Computer System Validation Specialist - Engineering Human Health

Job Description

Our IT team sees itself as a strategic partner to the business, developing innovative ideas and solutions that create new organizational opportunities. Through close international collaboration, we provide services and solutions that boost productivity and enable innovation.

Do you want to combine modern automation technology, GMP requirements, and innovative production processes? Then join our Qualification & Automation team at our Burgwedel site.

In this role, you will take responsibility for automated production facilities and computer-based systems in a highly regulated pharmaceutical environment. Together with production, engineering, quality assurance, and engineering teams, you will ensure that our facilities are operated safely, efficiently, and in compliance with GMP.

Your Tasks

Automation & System Support

• Support and further development of automated production facilities
• Assistance with error analysis and technical problem-solving in the production environment
• Participation in facility modernizations and new acquisitions

Computer System Validation (CSV)

• Planning, execution, and documentation of qualification and validation activities
• Creation and maintenance of lifecycle documents (URS, risk analyses, test documentation, periodic reviews)
• Ensuring compliance with GMP and Data Integrity requirements

Continuous Improvement

• Identification and implementation of optimization potential
• Participation in investment and improvement projects
• Promotion of Lean and Continuous Improvement principles

Your Profile

• Completed degree in automation technology, electrical engineering, computer science, process engineering, pharmaceutical engineering, or a comparable qualification
• Experience in the automation of industrial facilities
• Ideally, knowledge of GMP-regulated environments
• Experience with PLC systems (e.g., Siemens S7/TIA Portal) and HMI systems is an advantage
• Knowledge in the field of Computer System Validation (CSV) or qualification/validation is desirable
• Structured and solution-oriented way of working
• Good written and spoken German and English skills

What We Offer

• Exciting tasks in a state-of-the-art vaccine plant
• Responsibility for innovative production and automation systems
• collaboration with international teams
• Extensive training and development opportunities
• Attractive compensation and social benefits
• Flexible working time models

Together, we ensure that life-saving vaccines are produced safely and reliably.

Our Support Functions create value for the company by providing services and recommendations for the further development of our work environment and corporate culture. This includes, among others, the areas of Human Resources, Finance, Information Technology, Legal, Procurement, Administration, Facility Management, and Security.

We are convinced that diverse perspectives, experiences, and talents form the foundation for innovation. Therefore, we promote an inclusive work environment where respectful exchange, collaboration, and equal opportunity are a matter of course. We welcome applications regardless of gender, age, ethnic origin and nationality, disability, religion or belief, sexual orientation, or other legally protected characteristics.

We are proud to be a company built on the values of its diverse, talented, and committed employees. The fastest way to drive innovative developments is to bring different ideas together in an inclusive environment. We encourage our colleagues to discuss their ideas objectively and tackle problems together. We see ourselves as an equal opportunity employer and are committed to promoting inclusive, diverse workplaces.

Required Skills:

Automation Engineering, Automation Technology, Building Automation Systems, Computer System Validation (CSV), Control Systems Integration, Cross-Functional Leadership, Customer Satisfaction, Customized Reporting, PLC Programming

Preferred Skills:

English Language, German Language

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

11/6/2026

***A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.