Engineer Msat Lm Validation

Johnson & Johnson MedTech

Leiden, South Holland, Netherlands
Base: 44,700.00 - 80,300.00 eur annually; bonus/eq...
Process validation of pharmaceutical equipment
Good manufacturing practices (gmp)
Data integrity principles (alcoa+)
The Manufacturing Science & Technology (MSAT) department is the leading partner in supporting process validation, technical product ownership, and deploying sophisticated technologies to enable the best value for patients

Job Summary

  • The Manufacturing Science & Technology (MSAT) department is the leading partner in supporting process validation, technical product ownership, and deploying sophisticated technologies to enable the best value for patients.
  • The Validation Engineer will assess, plan, and coordinate execution of process validation activities including qualification of mixing, buffer hold time, microbial hold time, and sterilization processes.
  • The role supports audits and inspections, maintains compliance with company policies, and leverages a global MSAT network to implement best practices.

Matching Summary

The Manufacturing Science & Technology (MSAT) department is the leading partner in supporting process validation, technical product ownership, and deploying sophisticated technologies to enable the best value for patients.

Salary

Base: 44,700.00 - 80,300.00 EUR annually; Bonus/Equity: Not specified; Benefits: Includes 8% holiday allowance

Skills & Requirements

Must-have

  • Process validation of pharmaceutical equipment
  • Good Manufacturing Practices (GMP)
  • Data integrity principles (ALCOA+)
  • Risk management and root cause problem solving
  • Technical product ownership
  • Audit and inspection support

Nice-to-have

  • Mixing validation expertise
  • Buffer and microbial hold time qualification
  • Sterilization process qualification
  • 6-Sigma/Lean continuous improvement
  • Effective communication skills
  • Mentoring and training capabilities

Key Requirements

  • Relevant MS/MBA or bachelor's degree with experience
  • 0-2 years relevant experience with MS degree or 2+ years with bachelor's
  • Experience in (bio)pharmaceutical industry or related academic experience
  • Knowledge of pharmaceutical regulatory requirements (FDA, EMEA, ICH, ISPE, PDA)
  • English proficiency required

Work Rights

Not specified

Tailored Resume

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