Process Validation Engineer
WHO ARE WE?
ROPU MIDI is a Regional Operating Unit that covers all local Human Pharma and Animal Health Operating Units across Belgium, Denmark, Norway, Finland, Greece, Portugal, Sweden, and The Netherlands. MIDI has a multicultural and diverse work environment. More than 1.800 employees are striving to work together to improve lives for patients and animals in our region.
THE OPPORTUNITY
As our Process Validation Engineer you will be responsible for performing end‑to‑end lifecycle process validation activities at our production site, supporting smooth technology transfer, the establishment of robust and compliant manufacturing processes, and continuous process optimization.
The position plays a key role in ensuring GMP compliance, adherence to regulatory and quality standards, and the effective implementation of validation processes to prevent operational risks.
This position based in Koropi, and reports directly to the Process Validation Coordinator.
Boehringer Ingelheim's site in Koropi, Greece, is a vital facility dedicated to the production of high-quality pharmaceutical products. Established in a strategic location near Athens, the Koropi site has played a significant role in the company's global operations, focusing on manufacturing, and distribution. Over the last year the facility is committed to innovation and excellence for human pharmaceuticals. Boehringer Ingelheim Koropi upholds the highest standards of safety, quality, security and environmental stewardship, aligning with the company's global priorities.
YOUR KEY RESPONSIBILITIES
- Execute process validation and technology transfer activities between production sites in line with defined requirements.
- Prepare, review, and maintain GMP‑compliant process validation documentation, including protocols and reports.
- Provide expert input during the review of process manufacturing procedures.
- Collaborate closely with production and cross‑functional stakeholders and proactively escalate bottlenecks, deviations, or issues when required.
- Coordinate and follow up on local process validation and transfer activities, ensuring timely and compliant execution.
- Maintain risk assessments (FMEAs) and Control Strategy Summaries (CSS) at local and/or global product level.
- Act as a Subject Matter Expert (SME) for process validation in local and global forums, sharing feedback and escalating topics as needed.
WHAT YOU SHOULD BRING TO THE TEAM
- Bachelor’s or Master’s degree in Chemical or Process Engineering, Pharmacology or related field.
- Some years of experience in the pharmaceutical industry, preferably in production and/or Quality.
- Customer‑focused mindset with strong decision‑making and planning skills, and the ability to work effectively in a cross‑functional environment
- Excellent command of Greek and good knowledge of English is required.
- Strong organizational abilities. You can manage multiple priorities and consistently meet deadlines.
WHAT WILL YOU GET IN RETURN?
Next to the opportunity to develop and challenge yourself while learning from a fast-paced environment:
- Work in a wellbeing-oriented organization (Premium access to Headspace and ongoing support and initiatives related to ways of working to help our employees to stay healthy and constantly improve the physical, emotional, mental, and spiritual well-being)
- Customized Development plan based on your role and aspirations, with several learning platforms such as LinkedIn Learning Premium, and access to international development opportunities and languages + training programs.
- Competitive salary (plus annual bonus, participation in company life insurance and private healthcare program)
We kindly ask you to submit your CV in English. Application deadline is April 17th
What’s next?
We will have a look at your CV and cover letter. If we see a match, we will invite you for an interview to get to know each other. We will keep you posted during the process!
Screening:
In order to comply with applicable export control laws, Boehringer Ingelheim periodically screens business relations (including job applicants) against sanctioned party lists (“SPL”). These checks may be performed by Boehringer Ingelheim or by any of its Affiliates. You acknowledge that Boehringer Ingelheim and/or its Affiliates will screen you against SPL and that for this purpose your personal data may be processed in relevant databases, including databases of third-party vendors that perform SPL screening for or on behalf of Boehringer Ingelheim or its Affiliates which may be located or accessible outside the EU. Boehringer Ingelheim is committed to ensuring an adequate level of protection of your personal data.