Engineer MSAT LM Validation

Validation Engineer MSAT Biotherapeutics Drug Substance (Fixed Term)
Leiden, South Holland, Netherlands.
Johnson & Johnson seeks a Validation Engineer for our Manufacturing Science & Technology (MSAT) department to support process validation, technical product ownership, and new technology deployment for biotherapeutic drug substance.

Key Responsibilities   Assess, plan and coordinate execution of SPV activities, including qualification of mixing, buffer hold time, microbial hold time, and sterilization processes.
Support projects as a core team member responsible for qualification activities, providing regular status updates in a timely manner.
Act as subject‑matter expert (SME) for one or more validation categories.
Leverage the global MSAT network to identify and implement best practices.
Support audits, inspections, and the department’s perpetual audit‑readiness activities.
Support the site change‑control program by performing validation impact assessments and delivering resulting implementation plans.
Maintain compliance with all company policies and procedures, including Quality, EH&S, Business, Credo, etc.
Qualifications

Education:

MS/MBA (e.g. (Bio)
Chemical Engineering, Biotechnology) with 0‑2 years of relevant experience OR bachelor’s degree with 2+ years of relevant experience.

Required experience:

(bio) pharmaceutical industry or related academic experience or education; knowledge of GMP, ALCOA+ data integrity principles, and equipment validation processes in regulatory environments (FDA, EMEA, ICH, ISPE, PDA, etc.).

Required skills:

effective communication, planning, documentation, risk management, root‑cause problem solving, knowledge management, and mentorship.

Preferred experience:

mixing validation, buffer and microbial hold time, sterilization (moist heat) qualification; 6‑Sigma/Lean or similar continuous improvement methodologies.
Language:
English required;
Dutch a plus.
Salary  Base salary 44,700.00–80,300.00

EUR annually, plus 8% holiday allowance.

#J-18808-Ljbffr