Validation Engineer, MSAT Biotherapeutics DS

Leiden - Netherlands

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

Job Function:

Supply Chain Engineering

Job Sub Function:

Manufacturing Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Leiden South Holland Netherlands

Job Description:

Validation Engineer MSAT Biotherapeutics DS (Fixed Term)

J&J Innovative Medicine a member of the Johnson & Johnson Family of Companies is recruiting for a Validation Engineer MSAT to be based in Leiden the Netherlands. Our site produces biotherapeutic drug substance and is growing our portfolio with the introduction of new clinical and commercial products.

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

The Validation Engineer is a member of the MSAT-SPV Team with the dedicated focus on:

Validation of Supporting Processes used for manufacturing equipment (i.e. cleaning mixing)
Process improvements benchmarking and standardization.
New technology deployment.

Key Responsibilities:

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

Qualifications

Education:

A relevant MS/MBA (i.e. (Bio)Chemical Engineering Biotechnology) with 0-2 years of relevant experience OR bachelors degree with 2 years of relevant experience (i.e. (bio)pharmaceutical industry).

Experience and Skills:

Required:

Experience with GMP following data integrity principles (e.g. ALCOA) ensuring accurate documentation.
Knowledge of validation process of equipment and related regulatory requirements and industry guidelines specific for the pharmaceutical industry (e.g. FDA EMEA ICH ISPE PDA etc.).
Skills in effective communication planning documentation practices risk management root cause problem solving and knowledge management.
Capability to train others within the team.

Preferred:

Experience in validation of cleaning processes for different manufacturing systems (i.e. clean in place systems cleaning vessels/ transfer lines equipment washers chromatography skids and packed chromatography columns).
6-Sigma/Lean or similar continuous improvement methodology experience

Other:

6-Sigma/Lean or similar continuous improvement methodology experience

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Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to racecolor religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contactAskGSto be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Accelerating Communication Detail-Oriented Execution Focus Facility Management Good Manufacturing Practices (GMP) Lean Manufacturing Principles Lean Supply Chain Management Manufacturing Engineering Manufacturing Science and Technology (MSAT) Problem Management Project Engineering Project Management Tools Project Support Report Writing Safety-Oriented Science Technology Engineering and Math (STEM) Application Technologically Savvy

Required Experience: