Senior Engineer

2 dagen geleden

Breda, Noord-Brabant, Nederland Real Voltijd

Senior Engineer

Location:
Breda

Working Hours:
Full-time (40 hours/week)

Start Date:
ASAP

About the Company

We are a values-based organization with a powerful sense of shared purpose toward our mission: to serve patients. We provide the capabilities, resources, and rewards of a global enterprise while maintaining the entrepreneurial spirit that marked our early days as a biotechnology innovator. We encourage our team members to have fulfilling and meaningful careers through challenging assignments, career development, and valuable opportunities.

What You Will Do

The CPO site PD and PE department is responsible for introducing new products and technologies to packaging operations and ensuring smooth line performance. As a Senior Engineer, you will work closely with the operating team as an advisor while driving long-term projects such as new products, equipment, and process improvements.

Key responsibilities include:

  • Managing new product introductions or transfers into the packaging line, including characterization, functional testing, sample creation, and RTE/CRT analysis.
  • For this role, you will focus on transferring products to a partner manufacturing organization in Algeria.
  • Evaluating, recommending, and selecting new packaging materials.
  • Assessing complex problems related to process, equipment, or materials and implementing solutions.
  • Writing test and characterization protocols, performing technical evaluations, and submitting technical assessment reports.
  • Ensuring all projects meet deadlines and providing updates to senior management and the wider team.
  • Participating in Pre-Approval Inspections (PAI) and interacting with regulatory bodies (e.g., FDA, EMEA).
  • Collaborating with cross-functional teams (Methods Transfer, Engineering, Validation, QA, Supply Chain, Maintenance, Manufacturing, etc.).

What We Expect of You

Must-have qualifications:

  • Bachelor's or Master's degree in Engineering or similar.
  • Minimum 5 years of experience directly related to packaging materials.
  • Proven track record in the pharmaceutical industry or similarly regulated environment.
  • Experience or ambition to lead teams and develop team members.
  • Independent thinker with demonstrated ability to work in teams or lead projects.
  • Strong interpersonal and communication skills.

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