Job Title: Critical Process Lead
About the Role:
We are seeking a seasoned professional to lead our qualification and commissioning efforts in two major initiatives at a Small Molecule site. As a Critical Process Lead, you will oversee the remediation project following current assessments and gap analysis, as well as a capacity expansion project involving a new Spray and Post Dryer unit.
Your responsibilities will include:
* Leading qualification and commissioning efforts in both remediation and expansion projects
* Defining C&Q strategy and plans aligned with GMP and Risk-Based C&Q principles
* Ensuring timely execution of documentation, FATs, commissioning, and qualification activities (IQ/OQ/PQ)
* Collaborating with internal and client stakeholders to ensure project alignment
* Supporting audits and regulatory inspections as C&Q subject matter expert
* Cooking validation professionals involved in the project lifecycle
Requirements:
To be successful in this role, you will need:
* BSc/MSc degree in Life Sciences, Engineering, or related field
* Minimum 10 years of experience in Commissioning & Qualification within life sciences
* Solid knowledge of Small Molecule manufacturing and Risk-Based C&Q methodology
* Familiarity with GMP, FDA, EMA regulations
* Fluent in English; Dutch is a plus
* Proven leadership and stakeholder management skills
* Analytical, solution-oriented, and able to manage complex project dynamics
What We Offer:
We offer a dynamic work environment, opportunities for growth and development, and a competitive compensation package.