Commissioning & Qualification Lead
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This role is an opportunity to take the lead in commissioning and qualification efforts for a Small Molecule site. The successful candidate will oversee two major initiatives: a site-wide C&Q remediation project and a capacity expansion project involving a new Spray and Post Dryer unit.
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Responsibilities:
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* Lead qualification and commissioning efforts in both remediation and expansion projects.
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* Define C&Q strategy and plans aligned with GMP and Risk-Based C&Q principles.
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* Ensure timely execution of documentation, FATs, commissioning, and qualification activities (IQ/OQ/PQ).
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* Collaborate with internal and client stakeholders to ensure project alignment.
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* Support audits and regulatory inspections as C&Q subject matter expert.
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* Coach validation professionals involved in the project lifecycle.
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Requirements:
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* Bachelor's or Master's degree in Life Sciences, Engineering, or related field.
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* Minimum 10 years of experience in Commissioning & Qualification within life sciences.
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* Solid knowledge of Small Molecule manufacturing and Risk-Based C&Q methodology.
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* Familiarity with GMP, FDA, EMA regulations.
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* Fluent in English; Dutch is a plus.
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* Proven leadership and stakeholder management skills.
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* Analytical, solution-oriented, and able to manage complex project dynamics.
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