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Open nowPosted 84 days ago

Validation Engineer

Northway Biotech10 open roles

Where
Vilnius, Lithuania
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Your applicationOpen nowValidation EngineerNorthway Biotech · Vilnius, Lithuania

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  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

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The clock on this job

Early applications get read.

11.5% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.0%1 day
  2. 4.3%3 days
  3. 11.5%7 days
  4. 18.1%14 days
  5. 35.6%30 days
  6. 44.6%60 days
This job: posted 84 days ago

The posting

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).
  • Proficiency in English and Lithuanian.

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.
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