Plant Microbiologist

Biopharma Careers; Leiden; On-site; EUR 69,000 - 120,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being reimbursement

Insurance plans

Job summary

Johnson & Johnson in Leiden, Netherlands seeks a Contamination Control Specialist to support and lead contamination control activities in GMP manufacturing. You will drive CCP improvements, investigations, CAPA, and translate microbiological risk into practical shop-floor controls.

The role covers EM program qualification, cleaning validation oversight, data trending, and ongoing training to strengthen aseptic practices across global sites. Fluent English preferred.

Qualifications

• BSc in Microbiology, Biotechnology, Biology, Chemical Engineering, or similar; MSc preferred.
• Several years’ GMP-regulated manufacturing experience in Microbiology/QA/Operations.
• Experience with contamination control concepts and EM programs.

Responsibilities

• Support CCP for Operations, assess procedure effectiveness and drive improvements.
• Lead contamination investigations, root cause analysis, CAPA and verification.
• Translate microbiological risk into operational controls and EM strategies.
• Trend data, monitor KPIs, and drive risk-reduction improvements.
• Deliver aseptic practices training and promote cultural capability.
• Advise on facility/process design from a microbiological perspective.

Skills

GMP manufacturing

Root cause analysis

Data interpretation

English communication

Education

BSc in Microbiology or related

MSc preferred

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through 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 humanity.Learn more at jnj.com .

Job Function:

Supply Chain Manufacturing

Job Sub Function:

Manufacturing Pharmaceutical Process Operations

Job Category:

Professional

All Job Posting Locations:

Leiden, South Holland, Netherlands

Job Description:

Key responsibility areas

• A. Contamination Control Program (CCP) support for Operations.Assesses procedure effectiveness, drives improvements, and ensures inspection readiness.
• B. Leads contamination investigations, root cause analysis, and CAPA.Ensures scientifically sound interpretation and investigation rigor, including:
  • Leads or supports deep-dive analysis of contamination events (protocol review, sample/data assessment, interpretation, and validity of conclusions).
  • Leads or supports remediation of relevant inspection observations.
  • Performs contamination impact assessments for change controls and provides the Operations recommendation.
  • Drives root cause identification and CAPA definition, implementation follow-up, and closure.
  • Validates investigation outcomes and ensures appropriate scientific justification.
  • Ensures effectiveness checks are completed to prevent recurrence and strengthen contamination control.
• C. Translator of microbiological risk into operational controls.supports microbiological risk assessment (facility and process), translates risks into practical controls, and supports practical execution of environmental monitoring (EM) and microbiological control strategies, including:
  • EM program qualification (e.g., EMPQ), periodic review of alert/action limits, and investigation of EM deviations.
  • Effectiveness of cleaning, disinfection, and sanitization strategy in Operations.
  • Oversight of sterilization and filtration validation and routine execution monitoring.
• D. Data trending, performance management, and continuous improvement.Reports and trends contamination and leakage rates and other performance indicators; communicates insights and priorities to stakeholders; and drives risk-reduction improvements by identifying opportunities, challenging the status quo, and supporting implementation of sustainable microbiological controls.
• E. Enabler of culture, qualification, and training in aseptic practices.Executes the training curriculum for microbiological hygiene and contamination prevention.
• F. Subject matter expert (SME) for contamination control.Advises on facility and process design from a microbiological perspective and shares expertise with other sites and global stakeholders.

Minimum Qualifications and Drivers

• BSc in Microbiology, Biotechnology, Biology, Chemical Engineering, or similar (MSc preferred), or equivalent experience.
• Several years’ experience in GMP-regulated manufacturing (biopharmaceutical/sterile/aseptic preferred) in Microbiology, Manufacturing Science & Technology, QA, or Operations support.
• Demonstrated experience with contamination control concepts and environmental monitoring (EM program design/optimization, EM qualification such as EMPQ, sampling strategies, and trending).
• Working knowledge of relevant GMP expectations and guidance (e.g., EU GMP/EudraLex Annex 1; FDA aseptic processing guidance) and how to translate them into practical shop-floor controls.
• Proven investigation and problem-solving capability (root cause analysis, CAPA definition/follow-up; handling deviations/inspection observations with scientific rigor).
• Ability to interpret microbiological and process data, build meaningful metrics/KPIs, and communicate insights to stakeholders.
• Strong written and verbal communication skills in English; Dutch preferred.

Pay Ranges

• The anticipated pay range for this position, in the primary posting location, is: €68600,00 - €119600,00
• The anticipated pay ranges for additional locations are: Netherlands – The anticipated base pay range for this position is 82,900.00 - 166,000.00

Benefits:

• 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, 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.