Contamination Control Program Lead
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Job Location:
Leiden - Netherlands
Monthly Salary:
€ 144210 - 144210
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:
QualityJob Sub Function:
Quality SystemsJob Category:
People LeaderAll Job Posting Locations:
Leiden NetherlandsJob Description:
J&J Innovative Medicine is recruiting for a Contamination Control Program Lead reporting to the Site Quality Head Leiden Biotherapeutics and to be based in Leiden (Netherlands).
Job Summary
Key microbiological expert partnering with site leadership to develop maintain and improve contamination prevention and hygiene programs. You will act as the primary subject matter expert providing pragmatic guidance on contamination risk prevention under cGMP standards.
Key Responsibilities
Lead contamination control program risk assessments and strategies in line with cGMP Johnson & Johnson and regulatory standards.
Drive initiatives to reduce contamination risks and enhance microbiological hygiene practices.
Oversee environmental monitoring programs trend analysis and microbiological investigations for excursions.
Design implement and deliver microbiology training and contamination control measures including aseptic techniques cleaning disinfection and sterilization.
Collaborate on equipment and facility design validation and critical change approvals.
Review quality control documents such as SOPs and work instructions.
Innovate strategies for contamination reduction including hand hygiene gowning and hygiene practices.
Ensure microbiological quality standards are met for cleaning sterilization filtration and depyrogenation.
Advise on aseptic techniques and operator behaviors to minimize cross-contamination.
Analyze microbiological and particulate trends supporting corrective and preventative actions.
Coordinate with microbiology and contamination control teams and ensure supplier compliance.
Support regulatory compliance safety policies and best practices.
Collaborate across teams to share best practices and support resource planning.
Requirements:
Minimum of 10 years GMP experience in microbiology preferably within the pharmaceutical or biotech industry
Masters degree or PhD in Microbiology or a related field
Fluent in English (spoken and written)
Proven leadership experience including leading teams and projects with demonstrated ability to operate effectively in a matrix organization
Strong understanding of microbiological testing methods validation and regulatory compliance
Preferred Skills:
Experience working in a highly regulated environment
Excellent communication organizational and problem-solving skills
Ability to work independently and as part of a multidisciplinary team
This role offers an exciting opportunity to impact microbiological quality and contamination control in a dynamic manufacturing environment.
The anticipated base pay range for this position is 82900 EUR to 144210 EUR on an annual basis and includes 8% holiday allowance
Required Skills:
Contamination Control Quality Control SystemsPreferred Skills:
Data Quality Developing Others Leadership Quality Control (QC) Quality Management Systems (QMS) System Integration Team ManagementRequired Experience:
Senior IC
Key Skills
- Project Management Methodology
- Project / Program Management
- Program Management
- Management Experience
- Microsoft Powerpoint
- Project Management
- Microsoft Project
- Budgeting
- DoD Experience
- Leadership Experience
- Supervising Experience
- Contracts
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
