Engineer MSAT LM Validation
Share
Job Location:
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 .
As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Supply Chain EngineeringJob Sub Function:
Manufacturing EngineeringJob Category:
Scientific/TechnologyAll Job Posting Locations:
Leiden South Holland NetherlandsJob Description:
Validation Engineer MSAT Biotherapeutics Drug Substance (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 (e.g. mixing validation buffer and microbial hold time sterilization).
Process improvements benchmarking and standardization.
New technology deployment.
Key Responsibilities:
Assess plan and coordinate execution of SPV activities such as 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 expert matter (SME) for one or more validation categories. Leverage global MSAT network to identify and implement best practices.
Support audits and inspections 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 (e.g. (Bio)Chemical Engineering Biotechnology) with 0-2 years of relevant experience OR bachelors degree with 2 years of relevant experience.
Experience and Skills:
Required:
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.
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 mentor and train others within the team.
Preferred:
Experience in mixing validation buffer and microbial hold time sterilization (moist heat) qualification.
6-Sigma/Lean or similar continuous improvement methodology experience.
Other:
Language: English proficiency required; Dutch is a plus.
The anticipated base pay range for this position is 44700.00 - 80300.00 EUR on an annual basis and includes 8% holiday allowance
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 SavvyRequired Experience:
IC
Key Skills
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more
