Senior Process Engineer

Johnson & Johnson is hiring a Process Engineer to join our Downstream Processing (DSP) team in Leiden, the Netherlands. This role focuses on commercial-scale purification processes and related equipment, supporting four commercial products.

As a Process Engineer, you'll play a key role in maintaining and improving production processes, driving operational efficiency, and supporting continuous improvement initiatives. You'll collaborate closely with management, operations, and cross-functional teams to ensure alignment with production goals and regulatory standards.

Responsibilities

• Maintain and optimize DSP processes and purification equipment at commercial scale.
• Lead and support investigations into non-conformances (NCs), deviations, CAPAs, and change controls.
• Drive process improvements and support tech transfer and new product introductions (NPI).
• Ensure compliance with GMP and quality management systems (e.g., Comet, Viva, Trackwise).
• Manage and maintain documentation including batch records, SOPs, work instructions, and DPFD structures.
• Conduct Gemba walks to observe manufacturing processes and lead sustainable improvements in safety, quality, reliability, cost, and scheduling.
• Collaborate on Continuous Process Verification (CPV) activities and data analysis.
• Act as a key contributor to Product Impact Assessments and Change Control processes.

Your First Tasks

• Get familiar with existing commercial cell lines, DSP processes, and equipment.
• Review batch records and participate in NC investigations.
• Adapt to variable batch outcomes and workload peaks with flexibility and resilience.

Functie-eisen

• Preferred: Master's degree with 4-5 years of relevant experience OR Bachelor's degree with 8+ years of experience.
• English C1 language levels are required.
• Also considered: PhD holders with hands-on process engineering or development experience.
• Industry background: Candidates from the pharmaceutical industry are strongly preferred due to familiarity with regulatory environments and shorter onboarding times.
• GMPcertificate
• Experienced with laboratory management systems (e.g., Comet, Viva, Trackwise).

Competenties

• DeAbility to deliver assigned tasks independently and collaboratively.
• Strong communication with stakeholders.
• Resilience in fluctuating workload environments.

Arbeidsvoorwaarden

• Duration: 1-year contractor role with potential for extension.
• Working model: Hybrid - 3 days onsite, 2 days remote.
• One-year contract with the intention to offer a permanent contract afterward.
• Discount on the collective health insurance plan via Zilveren Kruis.
• Access to the Yacht network of companies and industry specialists.
• Generous referral program - up to €1,500.
• Attractive pension scheme (STIPP).
• 8.33% holiday allowance.
• Commuting reimbursement - €0.23 per kilometer up to 26km one way.
• Soft skills coaching - you'll be assigned a coach (if desired) from your professional field to spar with and guide you. Additionally, you'll have a dedicated Yacht contact person to help shape your career ambitions and create a development plan together

Contactinformatie

Voor meer informatie neem contact op met Nicole Miggels 06-

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