Senior Engineer MSAT Validation

Senior Engineer MSAT Validation – Biotherapeutics Drug Substance

Location:

Leiden, South Holland, Netherlands.

Key Responsibilities

Lead the execution of validation activities such as sterilization (moist heat) performance qualification.

Write and review validation plans, protocols and reports.

Act as a project core team member responsible for performance qualification activities:

Defining validation strategy.

Representing MSAT in multidisciplinary teams and aligning with extended team members.

Planning and delivering team and project goals and objectives.

Communicating with stakeholders, managing timelines, providing project status updates and escalating issues.

Defining validation strategy.

Participate in preparation and represent MSAT as SME in audits and inspections.

Perform change control assessments and execute against assigned actions.

Act as coach for more junior engineers.

Maintain compliance with all company policies and procedures (e.g., Quality, EH&S, Business, Credo, etc.).

Qualifications
Education : A relevant MS/MBA/Ph.D. degree (e.g., Science, Engineering, Biotechnology) or equivalent with minimum of 2 years of relevant experience OR a Bachelor’s degree (e.g., Science, Engineering, Biotechnology) with minimum of 4 years of relevant experience in the (bio) pharmaceutical industry.

Relevant experience in the (bio) pharmaceutical industry or related academic experience or education.

Experience with GMP, following data integrity principles (e.g., ALCOA+) ensuring proper documentation.

Experience in performance qualifications of equipment and related regulatory requirements and industry guidelines specific to the pharmaceutical industry (e.g., FDA, EMA, WHO, ISO, ICH, ISPE, PDA).

Experience in sterilization (moist heat) qualification.

Skills in technical writing and documentation practices, effective communication, planning, risk management, root‑cause problem solving, knowledge management and stakeholder management.

Capability to coach and train others within the team.

Preferred

Experience in audits and inspections (e.g., IGJ, FDA).

6‑Sigma/Lean or similar continuous improvement methodology experience.

Language
English proficiency required;
Dutch is a plus.

Compensation and Benefits
The anticipated base pay range for this position is €53,500.00 – €85,445.00.

In addition to base pay, we offer the following benefits: an annual bonus with a target percentage of pay depending on pay grade/location, vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well‑being reimbursement, programs for financial, physical and mental health. We also offer service‑anniversary and recognition awards, and, subject to the terms of their respective plans, employees—and in some locations eligible dependents—can participate in several insurance plans.

This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

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