Our client – Northway Biotech – a group of companies in the biopharmaceutical sector, developing innovative and biosimilar biologic products for clinical use and large-scale production. Company aims to be the leader in development & production of biopharmaceuticals for a better life for patients. As CDMO (Contract Development and Manufacturing Organization), company supports the global pharmaceuticals market with the capability to develop biopharmaceuticals from the gene to the manufacturing of the final drug product.
We are seeking a motivated and detail-oriented Validation Engineer to join our client biologics CDMO operations team. The successful candidate will support qualification and validation activities for GMP manufacturing equipment, utilities, facilities, computerized systems, and processes used in the production of biologics products.
This role works cross-functionally with Manufacturing, Quality Assurance, Quality Control, Engineering, Automation, and Regulatory teams to ensure compliance with cGMP, FDA, EMA, and industry standards.
Position description
- Execute and support qualification and validation activities including:
- IQ/OQ/PQ protocols
- Cleaning validation
- Computer system validation (CSV)
- Utility and facility qualification
- Prepare, review, and approve validation documentation, protocols, reports, risk assessments, and deviations.
- Coordinate validation activities with internal departments and external vendors.
- Support commissioning and startup of new manufacturing equipment and systems.
- Ensure compliance with GMP requirements and company quality standards.
- Participate in change control, CAPA, and deviation investigations related to validated systems.
- Maintain validation master plans and lifecycle documentation.
- Assist during regulatory inspections and customer audits.
- Drive continuous improvement initiatives within validation and engineering processes.
Expectations for the new colleague
- Bachelor’s degree in Engineering, Biotechnology, Pharmaceutical Sciences, or related technical field.
- Strong technical writing and documentation skills.
- Ability to manage multiple projects and work independently.
- Excellent communication and teamwork skills.
- Experience with GMP validation in a regulated industry (advantage).
- Knowledge of FDA, EMA, EU GMP, ISPE, and GAMP guidelines (advantage).
- Familiarity with biologics manufacturing processes and cleanroom operations is preferred.
- Experience in biologics CDMO or sterile manufacturing environments.
- Experience with single-use systems and upstream/downstream processing equipment.
- Understanding of data integrity and Annex 11 / 21 CFR Part 11 requirements (advantage).
Company offers
- Competitive salary. Salary range for this position: 2500 EUR to 3000 EUR gross (before taxes).
The final offer depends on competence, qualifications and experience. - Exposure to a cutting-edge biologics manufacturing environment.
- Opportunities for professional growth, career development in a state-of-the-art biotechnology setting.
- Innovative, hard-working and quality-driven, collaborative, supportive company culture.
