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Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Leiden, South Holland, Netherlands, Sassenheim, Netherlands

Job Description:

Janssen Biologics is currently recruiting a Process Microbiologist within our Quality Assurance department to strengthen our team. The Process Microbiologist, Sassenheim is responsible for providing input for microbiological and contamination control of lentiviral product production for clinical trials and commercial operation in a controlled cGMP cleanroom environment.

Function description:

The Process Microbiologist has a background in biopharmaceutical manufacturing process and/or quality. The Process Microbiologist supports the development and/or improvement of the contamination control strategies, contamination prevention, and microbiological hygiene programs. They act as the primary microbiological SME and collaborate with relevant departments to provide input for process/facility contamination control, performance of microbial qualifications, microbiological monitoring, investigation of microbiological contamination issues and provide microbiological training in the facility. Process Microbiologist gives practical advice to production operators, quality and operations departments, and management on topics concerning contamination risk prevention.

Essential Job Duties and Responsibilities:

• Ensure contamination control strategy is followed and maintained

• Review changes related to design/improvement/maintenance of facilities, gowning, cleaning & disinfection, restriction of movement etc.

• Play a lead and proactive role in development and delivery of microbiology related training programs including aseptic operator training

• Identify contamination risks and drives improvements related to the reduction of contamination risks on the shop floor with close cooperation with operators and management of the Manufacturing, and Maintenance departments

• Actively supports technical investigations where microbiological input is required, and is part of contamination task forces

• Oversight of environmental monitoring program including review of routine/process environmental monitoring, water system and utility data for trends and support identification of appropriate corrective/preventive actions as required

• Maintain current knowledge of regulations and industry trends in contamination control

• Work closely with other key stakeholders including the QC Microbiology and QC personnel, Quality Assurance, Compliance groups and Operations

Additional duties

• Work closely with other key stakeholders including the QC Microbiology and QC personnel, Quality Assurance, Compliance groups and Operations

• Network and communicate with other Process Microbiologists at JSC sites within the organization

• May support in internal/external audits

Minimum Qualification

• BSc. or MSc degree in science, preferably in Microbiology

• At least 3 years of work experience in biopharmaceutical production/quality environment.

• Experience in and or knowledge of biological pharmaceutical production related microbial contamination control

• Excellent communication skills, written and verbal in English

Preferred skills

• Experience in and or knowledge of biopharmaceutical production process and EUDRALEX Volume 4 Annex 1 and Annex 2, low bioburden processing, aseptic processing (Fill / Finish), viral production, biosafety level 2 containment facilities and isolators

• Experience affinity with EUDRALEX volume 4 Annex 1, Annex 2, part 4 and cGMP standards

• Excellent communication skills, written and verbal in Dutch

We also would like to see the following Key Competencies

• You are enthusiastic, independent, innovative (be able to think outside the box) and stress resistant (be able to deal with pressure, fast changes)

• You are able to act as trainer on your expertise

• You take ownership of your work and have the ability to plan and structure this

The anticipated base pay range for this position is 53,500 EUR to 85,445 EUR on an annual basis and includes 8% holiday allowance.

In addition to base pay, we offer the following benefits: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, and 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 location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

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

Required Skills:

Preferred Skills:

Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Human-Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards